SOPHI: Self-care in Older Frail Persons With Heart Failure Intervention

Sponsor

Karolinska Institutet (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05009706

Collaborator

Karolinska University Hospital (Other)

212

Enrollment

Location

Arms

41.8

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall purpose of the randomized controlled study is to evaluate the effects of physical exercise, nutrition and symptom management on physical capacity in older, frail persons with heart failure.

Condition or Disease	Intervention/Treatment	Phase
Self Care Heart Failure Frailty	Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)	N/A

Detailed Description

The randomized controlled study will be conducted in order to evaluate the effects of individual needs of physical exercise, nutrition, and symptom management in patients with heart failure who are frail and older. Patients discharged from a geriatric hospital will be recruited and included after informed consent. Two weeks after hospital discharge patients are randomized to intervention or control group. The intervention period is 3 months. With support from a physioterapeut, dietician and a registered nurse, the intervention will be performed in the participants´ home. Once a week participants will come to the hospital for physical exercise led by a physiotherapist. Once a week or every other week participants will meet a dietician and a nurse. Data will be collected at baseline, and 3 and 6 months after baseline. Data consist of e.g. study flow description, number of eligible patients, number of drop-outs, patients sociodemographic- and clinical data, physical function and performance, nutritional status, symptom burden, self-care, appetite, thirst, health-related quality of life. At 12 months after baseline, data will be collected on hospital admissions, reasons for hospital admissions, length of stay and mortality.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Self-care in Older Frail Persons With Heart Failure Intervention (SOPHI). Individualized Physical Exercise, Diet and Symptom Management- A Randomized Controlled Trial.

Actual Study Start Date :

Sep 6, 2021

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self Care group Patients who are randomized to the intervention Self Care group will get advice and support on physical excercise, nutrition and symptom management to perform at home for 12 weeks. Once a week, patients will come to the hospital for follow-up and to exercise with a physiotherapist.	Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI) Patients who are randomized to the Self Care group will receive oral and written information, advice and support on following activities: excercise (from physiotherapist), nutrition (dietician) and symptom management (nurse), based on patient´s individual needs and abilities. The Self Care group will perform the activities daily at home. Once a week, patients come to the hospital to exercise with the support of a physiotherapist. Once a week or every other week patients will meet (at hospital or by phone) the dietician and nurse to solve possible problems and to follow-up food/nutrition intake and symptoms/symptom management.
No Intervention: Control group Patients who are randomized to the Control group will receive ordinary health care (from an outpatient clinic), but will also be encouraged to follow recommendation of 150 minutes/week of moderate physical activity (12 weeks). To compensate for the extra attention received by the intervention group by the advice/support, the patients in the control group will be dialed with a nurse at 3, 6 and 9 weeks to discuss their current activity.

Arm

Intervention/Treatment

Experimental: Self Care group

Patients who are randomized to the intervention Self Care group will get advice and support on physical excercise, nutrition and symptom management to perform at home for 12 weeks. Once a week, patients will come to the hospital for follow-up and to exercise with a physiotherapist.

Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)

Patients who are randomized to the Self Care group will receive oral and written information, advice and support on following activities: excercise (from physiotherapist), nutrition (dietician) and symptom management (nurse), based on patient´s individual needs and abilities. The Self Care group will perform the activities daily at home. Once a week, patients come to the hospital to exercise with the support of a physiotherapist. Once a week or every other week patients will meet (at hospital or by phone) the dietician and nurse to solve possible problems and to follow-up food/nutrition intake and symptoms/symptom management.

No Intervention: Control group

Patients who are randomized to the Control group will receive ordinary health care (from an outpatient clinic), but will also be encouraged to follow recommendation of 150 minutes/week of moderate physical activity (12 weeks). To compensate for the extra attention received by the intervention group by the advice/support, the patients in the control group will be dialed with a nurse at 3, 6 and 9 weeks to discuss their current activity.

Outcome Measures

Primary Outcome Measures

Change in physical performance [3 months]
The "Short Physical Performance Battery" is composed of "standing balance", "gait speed", and "timed repeated chair rise". The total score range from minimum 0 to maximum 12, with higher scores indicating better physical performance.

Secondary Outcome Measures

Symptom burden [Baseline, 3 and 6 months]
Assessed by the questionnaire titled "The Memorial Symptom Assessment Scale- Heart Failure", that evaluates symptoms experienced by the patient in the last week (a total of 36 symptoms, for example pain, nausea, tiredness). A score of 0 is given to a symptom if it is absent. If the symptom is present, it is rated using a four-point rating scale (1-4) for frequency and severity, and a five-point rating scale (0-4) for distress of the symptom with higher scores indicating greater frequency, more severity and higher distress. For each symptom, the average of the frequency, severity and distress will be calculated to produce the outcome symptom burden (total scores ranging from minimum 0 to maximum 4, with higher scores indicating greater symptom burden).
Health related quality of life [Baseline, 3 and 6 months]
Assessed with the Euroqol questionnaire titled "The EQ-5D". It comprises five questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answer options are no problems (score 1), moderate problems (score 2), severe/extreme problems (score 3). The results are converted into a single index value (minimum value 0 to maximum value 1). Higher value indicate better health related quality of life
Aerobic capacity/endurance [Baseline, 3 and 6 months]
Assessed with the 6-minute walk test, the distance in meters covered over a time of 6 minutes
Frailty [Baseline, 3 and 6 months]
Assessed by the scale titled "Clinical Frailty Scale". From the minimum value 1 (patient is very fit) to the maximum value 9 (terminally ill). Higher score indicates more frailty
Perceived physical effort [Baseline, 3 and 6 months]
Assessed with the scale titled "Borg Category Ratio-10 Scale" of perceived exertion. The minimum value is 0 (nothing at all) to the maximum value 10 (extremely strong or maximal). Higher value indicate worse physical effort
Hand strength [Baseline, 3 and 6 months]
Assessed with the hand-gripdynamometer (JAMAR)
Hospital readmissions [12 months]
The number of hospital readmissions during a 12 month period will be retrieved from the patients medical record
Lower body strength [Baseline, 3 and 6 months]
Sit to stand test measure the number of uprising from a chair during 30 seconds
Nutrition status [Baseline, 3 and 6 months]
Assessed by the "Mini Nutritional Assessment" screening. The total score range from minimum 0 to maximum 14. Higher scores indicate better nutrition status
Inflammation marker [Baseline, 3 and 6 months]
Plasma C-reactive protein (mg/L), reference interval value below 3 mg/L. Higher value indicate inflammation in the body
Sarcopenia [Baseline, 3 and 6 months]
Measured by the criteria of European Working Group on Sarcopenia in Older People's

Other Outcome Measures

Objective physical activity [Baseline, 3 and 6 months]
Measured with a non-invasive miniature electronic logger during 4-5 days per time frame
Subjective physical activity [Baseline, 3 and 6 months]
Assessed by the instrument titled "International Physical Activity Questionnaire" (IPAQ). Measure the minutes of physical activity during a day.
Experiences of patients [3 months]
A qualitative interview will be used to collect data on patient´s experiences of the intervention
Self-care [Baseline, 3 and 6 months]
Assessed with the questionnaire titled "Self-care of chronic illness inventory" (30 questions). Minimum score is 28 and maximum score is 150. Higher score indicate better self care
Appetite [Baseline, 3 and 6 months]
Assessed with the questionnaire titled "The Council on Nutrition Appetite Questionnaire" (8 questions)Failure". Minimum score is 8 and maximum score is 40. Higher score indicate better appetite
Thirst distress [Baseline, 3 and 6 months]
Assessed with the questionnaire titled "Thirst Distress Scale for patients with Heart Failure" (8 questions) Minimum score is 8 and maximum score is 40. Higher score indicate higher thirst distress

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients at geriatric clinic
Diagnosed with heart failure (independent of Ejection Fraction (EF): both patients with preserved EF or reduced EF can be included
New York Heart Association functional class II - III
Clinical frailty level 4-6 (moderate frailty)
Discharge from hospital to home

Exclusion Criteria:

New York Heart Associacion functional class I or IV
Clinical frailty level 1-3 (no/mild frailty) and 7-9 (severe frailty)
The patient is unable to perform gait tests due to visual (see a TV screen at a 3 meter distance), cognitive (assessed by nurse or doctor) or motor impairment (the patient should be able to stand up from sitting and have the ability to walk with or without a walker or other walking aid).
The patient is unable to follow instructions (assessed by nurse or doctor)