HSS: Insomnia Self-Management in Heart Failure
Study Details
Study Description
Brief Summary
Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.
The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined.
A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education.
Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may contribute to the development and exacerbation of HF and incident mortality. It is also associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.However, insomnia is under-diagnosed and under-treated in this population.
Cognitive behavioral therapy for insomnia (CBT-I) is a multi-modal behavioral treatment focused on modifying beliefs and attitudes about sleep and is efficacious in many populations. The purposes of RCT are to evaluate the sustained effects of CBT-I, compared with HF self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention-control condition and explore the effects of CBT-I on event-free survival. We will address the following specific aims (*primary outcomes): (1) Test the sustained effects (baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks, compared with HF self-management education (attention control condition), on: (1a) *insomnia severity and self-reported and actigraph-recorded sleep characteristics (*sleep quality, *sleep efficiency, sleep latency, and duration); (1b) symptoms (*fatigue, anxiety, depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and (1c) symptom clusters [membership in clusters characterized by severity of specific symptoms; transition between clusters over time]; (2) Test the sustained effects of CBT-I on self-reported and objective functional performance; and (3) Examine the cost-effectiveness of CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival.
A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost-effectiveness analysis, and survival analysis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive Behavioral Therapy Cognitive behavioral therapy for insomnia (CBT-I) will be provided in a group format, led by an interventionist. CBT-I includes strategies for modifying thoughts and behaviors about sleep. Participants will be instructed on and practice methods for modifying their thoughts and behaviors about sleep and insomnia. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks. |
Behavioral: Cognitive Behavioral Therapy for Insomnia
This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.
Other Names:
|
| Active Comparator: Heart Failure Self-Management Education Heart Failure Self-management education is an intervention that will be provided by a nurse in a group format. This includes standard components, such as education about fluid and sodium management, heart failure medications, diet and physical activity. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks. |
Behavioral: Self-Management Education for Heart Failure
This is an educational education designed to teach patients about self-management their heart failure. It includes information on medications, lifestyle, cardiac devices, diet, and when to seek assistance from a health care provider.
|
Outcome Measures
Primary Outcome Measures
- Insomnia Severity [2 weeks post treatment]
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
- Fatigue [2 weeks post treatment]
The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
- Sleep Efficiency [2 weeks post treatment]
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
Secondary Outcome Measures
- Sleep duration [2 weeks post-treatment]
Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Sleep duration [6 months post-treatment]
Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Sleep duration [9 months post treatment]
Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Sleep duration [12 months post treatment]
Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Anxiety [2 weeks post intervention]
Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.
- Anxiety [6 months post intervention]
Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.
- Anxiety [9 months post intervention]
Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.
- Anxiety [12 months post iintervention]
Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.
- Depressive symptoms [Baseline]
Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.
- Depressive symptoms [2 weeks Post Treatment]
Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.
- Depressive symptoms [6 months post treatment]
Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.
- Depressive symptoms [9 months post treatment]
Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.
- Depressive symptoms [12 months post treatment]
Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.
- Sleepiness [Baseline]
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.
- Sleepiness [2 weeks Post treatment]
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.
- Sleepiness [6 months post treatment]
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.
- Sleepiness [9 months post treatment]
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.
- Sleepiness [12 months post treatment]
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.
- Dyspnea [Baseline]
Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.
- Dyspnea [2 weeks Post intervention]
Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.
- Dyspnea [6 months post treatment]
Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.
- Dyspnea [9 months post treatment]
Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.
- Dyspnea [12 months post treatment]
Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.
- Psychomotor vigilance [Baseline]
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
- Psychomotor vigilance [2 weeks Post treatment]
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
- Psychomotor vigilance [6 months post treatment]
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
- Psychomotor vigilance [9 months post treatment]
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
- Psychomotor vigilance [12 months post treatment]
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
- Functional performance [Baseline]
Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.
- Functional performance [2 weeks Post treatment]
Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.
- Functional performance [6 months post treatment]
Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.
- Functional performance [9 months post treatment]
Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.
- Functional performance [12 months post treatment]
Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.
- Functional capacity [Baseline]
Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
- Functional capacity [2 weeks Post treatment]
Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
- Functional capacity [6 months post treatment]
Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
- Functional capacity [9 months post treatment]
Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
- Functional capacity [12 months post treatment]
Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
- Cost effectiveness [Baseline]
Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.
- Cost effectiveness [2 months post treatment]
Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.
- Cost effectiveness [6 months post treatment]
Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.
- Cost effectiveness [9 months post treatment]
Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.
- Cost effectiveness [12 months post treatment]
Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.
- Event-free survival [1 year post treatment]
Event free survival will be measured as the absence of death (all cause), heart failure hospitalizations, heart failure emergency department visits, heart transplantation, or artificial heart (LVAD) until the end of the study period. Events will be assessed events through participant/family report and confirmed with the electronic medical record; a sub-set of the team blinded to group assignment will review data to determine cause of death/hospitalization. The National Death Index will be queried if information is otherwise unavailable.
- Insomnia Severity [Baseline]
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
- Insomnia Severity [6 months post treatment]
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
- Insomnia Severity [9 months post treatment]
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
- Insomnia Severity [12 months post treatment]
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
- Fatigue [Baseline]
The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
- Fatigue [6 months post treatment]
The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
- Fatigue [9 months post treatment]
The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
- Fatigue [12 months post treatment]
The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
- Sleep Efficiency [Baseline]
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Sleep Efficiency [6 months post treatment]
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Sleep Efficiency [9 months post treatment]
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
- Sleep Efficiency [12 months post treatment]
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
Eligibility Criteria
Criteria
Inclusion Criteria:
- stable chronic heart failure, chronic insomnia, English speaking/reading,
Exclusion Criteria:
- untreated sleep disordered breathing or restless legs syndrome, rotating/night shift work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting the non-dominant arm end-stage renal failure, significant cognitive impairment, unstable medical or psychiatric disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University School of Nursing | West Haven | Connecticut | United States | 06516-7399 |
Sponsors and Collaborators
- Yale University
- Milton S. Hershey Medical Center
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Nancy S Redeker, PhD, Yale University School of Nursing
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0904005041a
- R01NR016191