Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01672294
Collaborator
(none)
286
1
2
34
8.4
Study Details
Study Description
Brief Summary
Informal caregivers provide a majority of care for patients during serious illness. Lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care.
This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators propose a randomized control trial to evaluate an intervention of preparation and completion with Veterans and their caregivers during serious illness. Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate the impact of the intervention session's qualitative content, examining variation associated with selected demographic variables, quality of family communication, and stage of illness on change.
Caregivers in the first group ("Treatment", or "Preparation and life completion") will meet with a facilitator three times for a period of forty-five minutes each. In the first session, subjects will be asked to discuss issues related to relationship life review.
In session two, participants will be asked to speak in more depth about issues such as regret and forgiveness. In the final session, subjects will focus on legacy and celebration. Caregivers in the second group ("attention control" or "relaxation meditation") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation compact disk (CD) or participate in a guided relaxation exercise.
Participants in both groups will receive pre and post-test measures administered by a blinded interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy
- General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale, Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient days at home.
Study Design
Study Type:
Interventional
Actual Enrollment
:
286 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Study Start Date
:
Jun 1, 2013
Actual Primary Completion Date
:
Dec 1, 2015
Actual Study Completion Date
:
Apr 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: treatment three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver |
Other: Preparation and life completion
Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
| Active Comparator: attention control three facilitator led sessions of listening to a relaxation CD. |
Other: Attention Control
Caregiver subjects will listen to a non-guided relaxation CD with facilitator.
|
Outcome Measures
Primary Outcome Measures
- Caregiver Anxiety [Measured at baseline, 5 weeks, and 8 weeks]
Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).
Secondary Outcome Measures
- Spirituality [Measured at baseline, 5 weeks, and 8 weeks]
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).
- Depression [Measured at baseline, 5 weeks, and 8 weeks]
Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms
- Patient Days of VA Hospital Use [In the 6 months after randomization]
The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.
- Caregiver Burden [Measured at baseline, 5 weeks, and 8 weeks]
Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.
- Caregiver Completion [Measured at baseline, 5 weeks, and 8 weeks]
Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).
- Prolonged Grief - Number of Participants With Anticipatory Grief [Measured at baseline, 5 weeks, and 8 weeks]
The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.
- Caregiver Preparation [Measured at baseline, 5 weeks, and 8 weeks]
Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease.
Exclusion Criteria:
-
No caregiver present.
-
Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Durham VA Medical Center, Durham, NC | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Karen E Steinhauser, PhD, Durham VA Medical Center, Durham, NC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01672294
Other Study ID Numbers:
- IIR 11-347
First Posted:
Aug 24, 2012
Last Update Posted:
Apr 17, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study conducted recruitment from June 2013 to October 2015. Potential patients were identified by data pulls and then medical record review as well as obtaining approval to approach from providers. Patients were approached both at select outpatient clinics at the Durham VAMC as well as being sent invitation letters with subsequent phone calls. |
|---|---|
| Pre-assignment Detail | Participant pairs (seriously-ill veteran and primary informal caregiver) were consented and then each completed a baseline interview before the dyad was randomized. Enrolled participants may be excluded if either of the pair refused to consent or did not complete a baseline. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient |
|---|---|---|---|---|
| Arm/Group Description | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. |
| Period Title: Overall Study | ||||
| STARTED | 71 | 71 | 72 | 72 |
| COMPLETED | 65 | 50 | 61 | 59 |
| NOT COMPLETED | 6 | 21 | 11 | 13 |
Baseline Characteristics
| Arm/Group Title | Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.. | Total of all reporting groups |
| Overall Participants | 71 | 71 | 72 | 72 | 286 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
60.8
(11.32)
|
66.8
(7.85)
|
60.1
(12.05)
|
65.4
(9.21)
|
63.3
(10.59)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
67
94.4%
|
4
5.6%
|
67
93.1%
|
3
4.2%
|
141
49.3%
|
| Male |
4
5.6%
|
67
94.4%
|
5
6.9%
|
69
95.8%
|
145
50.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
3
4.2%
|
2
2.8%
|
2
2.8%
|
0
0%
|
7
2.4%
|
| Not Hispanic or Latino |
68
95.8%
|
69
97.2%
|
68
94.4%
|
72
100%
|
277
96.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
2
2.8%
|
0
0%
|
2
0.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
31
43.7%
|
29
40.8%
|
30
41.7%
|
32
44.4%
|
122
42.7%
|
| White |
36
50.7%
|
38
53.5%
|
33
45.8%
|
38
52.8%
|
145
50.7%
|
| More than one race |
4
5.6%
|
4
5.6%
|
7
9.7%
|
2
2.8%
|
17
5.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
2
2.8%
|
0
0%
|
2
0.7%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
71
100%
|
71
100%
|
72
100%
|
72
100%
|
286
100%
|
| Dyad Relationship (Count of Participants) | |||||
| Spouse |
52
73.2%
|
52
73.2%
|
53
73.6%
|
53
73.6%
|
210
73.4%
|
| Adult Child |
6
8.5%
|
2
2.8%
|
3
4.2%
|
1
1.4%
|
12
4.2%
|
| Sibling |
3
4.2%
|
3
4.2%
|
3
4.2%
|
3
4.2%
|
12
4.2%
|
| Parent |
2
2.8%
|
6
8.5%
|
1
1.4%
|
3
4.2%
|
12
4.2%
|
| Other |
8
11.3%
|
8
11.3%
|
12
16.7%
|
12
16.7%
|
40
14%
|
| Primary Diagnosis of Veteran (Count of Participants) | |||||
| Cancer |
43
60.6%
|
52
73.2%
|
95
131.9%
|
||
| Congestive Heart Failure |
6
8.5%
|
6
8.5%
|
12
16.7%
|
||
| Chronic obstructive pulmonary disease |
12
16.9%
|
5
7%
|
17
23.6%
|
||
| End Stage Renal Disease |
6
8.5%
|
6
8.5%
|
12
16.7%
|
||
| Multiple Qualifying Disease |
4
5.6%
|
3
4.2%
|
7
9.7%
|
||
| Education (Count of Participants) | |||||
| HS or less |
34
47.9%
|
33
46.5%
|
28
38.9%
|
31
43.1%
|
126
44.1%
|
| Some College |
22
31%
|
25
35.2%
|
31
43.1%
|
29
40.3%
|
107
37.4%
|
| College Degree |
12
16.9%
|
6
8.5%
|
5
6.9%
|
6
8.3%
|
29
10.1%
|
| Graduate Work or Degree |
3
4.2%
|
7
9.9%
|
8
11.1%
|
6
8.3%
|
24
8.4%
|
| Finances (Count of Participants) | |||||
| Difficulty paying bills |
10
14.1%
|
13
18.3%
|
6
8.3%
|
6
8.3%
|
35
12.2%
|
| Money to pay bills, cut back on things |
13
18.3%
|
14
19.7%
|
22
30.6%
|
13
18.1%
|
62
21.7%
|
| Enough to pay bills, little extras |
26
36.6%
|
22
31%
|
23
31.9%
|
30
41.7%
|
101
35.3%
|
| enough to pay bills and special things |
22
31%
|
22
31%
|
21
29.2%
|
22
30.6%
|
87
30.4%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
1
1.4%
|
1
0.3%
|
| Employment (Count of Participants) | |||||
| Working Full or Part Time |
21
29.6%
|
1
1.4%
|
19
26.4%
|
4
5.6%
|
45
15.7%
|
| Retired/Not Working |
43
60.6%
|
38
53.5%
|
42
58.3%
|
40
55.6%
|
163
57%
|
| Disabled |
7
9.9%
|
32
45.1%
|
10
13.9%
|
28
38.9%
|
77
26.9%
|
| Other |
0
0%
|
0
0%
|
1
1.4%
|
0
0%
|
1
0.3%
|
| Self-rated Quality of Health (Count of Participants) | |||||
| Excellent |
0
0%
|
0
0%
|
1
1.4%
|
0
0%
|
1
0.3%
|
| Very Good |
10
14.1%
|
1
1.4%
|
13
18.1%
|
4
5.6%
|
28
9.8%
|
| Good |
16
22.5%
|
11
15.5%
|
14
19.4%
|
8
11.1%
|
49
17.1%
|
| Fair |
9
12.7%
|
14
19.7%
|
9
12.5%
|
14
19.4%
|
46
16.1%
|
| Poor |
0
0%
|
9
12.7%
|
0
0%
|
12
16.7%
|
21
7.3%
|
| Missing |
36
50.7%
|
36
50.7%
|
35
48.6%
|
34
47.2%
|
141
49.3%
|
| Years of caregiving given or received (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
4.6
(5.6)
|
5.2
(5.95)
|
3.7
(4.06)
|
3.4
(4.2)
|
4.2
(5.04)
|
| Number of Hours patient requires assistance (hours) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [hours] |
2.4
(1.24)
|
2.3
(1.34)
|
2.3
(1.2)
|
2.1
(1.25)
|
2.3
(1.26)
|
Outcome Measures
| Title | Caregiver Anxiety |
|---|---|
| Description | Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ). |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 71 | 71 |
| Baseline |
6.9
(5.3)
|
7.3
(4.6)
|
| 5 week follow up |
5.9
(5.2)
|
5.4
(4.9)
|
| 8 week follow up |
5.8
(5.7)
|
6.4
(5.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.511 |
| Comments | Between Outlook Intervention and Attention Control caregivers at 5 weeks | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.5376 | |
| Confidence Interval |
(2-Sided) 95% -1.0776 to 2.1528 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6348 |
| Comments | Between Outlook Intervention and Attention Control caregivers at 8 weeks | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.4275 | |
| Confidence Interval |
(2-Sided) 95% -1.3505 to 2.2055 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Spirituality |
|---|---|
| Description | Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being). |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 71 | 72 |
| Baseline |
35.4
(9.0)
|
37.3
(7.2)
|
| 5 week |
36.1
(8.0)
|
37.3
(7.0)
|
| 8 week |
37.3
(8.3)
|
36.6
(7.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5225 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.6836 | |
| Confidence Interval |
(2-Sided) 95% -1.4278 to 2.7950 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1972 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.2764 | |
| Confidence Interval |
(2-Sided) 95% -0.6728 to 3.2257 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Depression |
|---|---|
| Description | Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary and secondary results are comparing caregiver scores in the two arms, not patient arms. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 71 | 72 |
| Baseline |
8.2
(6.6)
|
8.8
(5.5)
|
| 5 weeks |
8.7
(6.8)
|
8.0
(6.4)
|
| 7 weeks |
8.3
(6.2)
|
9.0
(6.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.3332 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.9358 | |
| Confidence Interval |
(2-Sided) 95% -0.9726 to 2.8443 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3842 |
| Comments | Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.6929 | |
| Confidence Interval |
(2-Sided) 95% -0.8783 to 2.2642 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Patient Days of VA Hospital Use |
|---|---|
| Description | The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations. |
| Time Frame | In the 6 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Caregiver Outlook - Patient | Relaxation Meditation - Patient |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 71 | 72 |
| Mean (Standard Deviation) [Days in VA hospital or ER] |
4.4
(11.8)
|
4.4
(9.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8748 |
| Comments | ||
| Method | Standard negative binomial with offset | |
| Comments | ||
| Method of Estimation | Estimation Parameter | expected change in difference in logs |
| Estimated Value | 0.0593 | |
| Confidence Interval |
(2-Sided) 95% -0.6784 to 0.797 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The expected change in the difference of the logs of expected Days in VA inpatient care or ED. | |
| Title | Caregiver Burden |
|---|---|
| Description | Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions. |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 70 | 70 |
| Baseline |
4.2
(0.6)
|
4.2
(0.6)
|
| 5 week |
4.2
(0.6)
|
4.2
(0.6)
|
| 8 week |
4.2
(0.6)
|
4.1
(0.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Between Outlook Intervention caregivers and active control caregivers at 5 weeks. Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7687 |
| Comments | Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01777 | |
| Confidence Interval |
(2-Sided) 95% -0.1372 to 0.1017 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9863 |
| Comments | Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.00087 | |
| Confidence Interval |
(2-Sided) 95% -0.1003 to 0.09861 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Caregiver Completion |
|---|---|
| Description | Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome). |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 70 | 71 |
| Baseline |
2.7
(0.8)
|
2.8
(0.8)
|
| 5 Week |
2.5
(0.9)
|
2.6
(0.9)
|
| 8 Week |
2.5
(1.0)
|
2.7
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | At 5 weeks - Completion subscale | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9221 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01166 | |
| Confidence Interval |
(2-Sided) 95% -0.2475 to 0.2241 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Caregiver Outlook - Caregiver, Relaxation Meditation - Caregiver |
|---|---|---|
| Comments | Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3249 |
| Comments | Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.1154 | |
| Confidence Interval |
(2-Sided) 95% -0.3466 to 0.1158 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Prolonged Grief - Number of Participants With Anticipatory Grief |
|---|---|
| Description | The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms. |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 71 | 72 |
| Baseline |
6
8.5%
|
2
2.8%
|
| 5 week |
2
2.8%
|
3
4.2%
|
| 8 week |
2
2.8%
|
2
2.8%
|
| Title | Caregiver Preparation |
|---|---|
| Description | Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome). |
| Time Frame | Measured at baseline, 5 weeks, and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate. |
| Arm/Group Title | Caregiver Outlook - Caregiver | Relaxation Meditation - Caregiver |
|---|---|---|
| Arm/Group Description | Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention). | Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
| Measure Participants | 36 | 37 |
| Baseline |
2.7
(0.7)
|
2.4
(0.8)
|
| 5 Week |
2.4
(0.8)
|
2.7
(0.7)
|
| 8 Week |
2.6
(0.8)
|
2.6
(0.8)
|
Adverse Events
| Time Frame | During time of study participation, 8 weeks per participant. Adverse events were collected both systematically, by asking of events at each time point, and non-systematically. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient | ||||
| Arm/Group Description | Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy. | Patients of the caregivers in the Outlook Intervention arm. | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. | Patients of the caregivers in the Attention Control arm. | ||||
All Cause Mortality |
||||||||
| Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/71 (0%) | 13/71 (18.3%) | 0/72 (0%) | 11/72 (15.3%) | ||||
| Cardiac disorders | ||||||||
| Cardiac | 0/71 (0%) | 0 | 2/71 (2.8%) | 2 | 0/72 (0%) | 0 | 2/72 (2.8%) | 2 |
| Gastrointestinal disorders | ||||||||
| Gastro-Intestinal | 0/71 (0%) | 0 | 1/71 (1.4%) | 1 | 0/72 (0%) | 0 | 0/72 (0%) | 0 |
| Infections and infestations | ||||||||
| Infection | 0/71 (0%) | 0 | 2/71 (2.8%) | 2 | 0/72 (0%) | 0 | 1/72 (1.4%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Injury | 0/71 (0%) | 0 | 0/71 (0%) | 0 | 0/72 (0%) | 0 | 1/72 (1.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Neoplasm | 0/71 (0%) | 0 | 3/71 (4.2%) | 6 | 0/72 (0%) | 0 | 3/72 (4.2%) | 5 |
| Neoplasm-death | 0/71 (0%) | 0 | 4/71 (5.6%) | 4 | 0/72 (0%) | 0 | 3/72 (4.2%) | 3 |
| Renal and urinary disorders | ||||||||
| Renal | 0/71 (0%) | 0 | 1/71 (1.4%) | 1 | 0/72 (0%) | 0 | 1/72 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Respiratory | 0/71 (0%) | 0 | 1/71 (1.4%) | 1 | 0/72 (0%) | 0 | 1/72 (1.4%) | 1 |
| Surgical and medical procedures | ||||||||
| Surgery | 0/71 (0%) | 0 | 1/71 (1.4%) | 1 | 0/72 (0%) | 0 | 0/72 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/71 (5.6%) | 7/71 (9.9%) | 4/72 (5.6%) | 11/72 (15.3%) | ||||
| General disorders | ||||||||
| Multiple/general | 0/71 (0%) | 0 | 4/71 (5.6%) | 4 | 0/72 (0%) | 0 | 2/72 (2.8%) | 2 |
| Infections and infestations | ||||||||
| Infection | 0/71 (0%) | 0 | 2/71 (2.8%) | 2 | 0/72 (0%) | 0 | 7/72 (9.7%) | 7 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Neoplasm | 0/71 (0%) | 0 | 5/71 (7%) | 5 | 0/72 (0%) | 0 | 3/72 (4.2%) | 5 |
| Psychiatric disorders | ||||||||
| Psychiatric | 4/71 (5.6%) | 6 | 0/71 (0%) | 0 | 4/72 (5.6%) | 5 | 0/72 (0%) | 0 |
| Vascular disorders | ||||||||
| Vascular/blood | 0/71 (0%) | 0 | 5/71 (7%) | 6 | 0/72 (0%) | 0 | 1/72 (1.4%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Karen Steinhauser, PhD |
|---|---|
| Organization | VA HSRD Durham VA Medical Center |
| Phone | 9196682148 |
| karen.steinhauser@va.gov |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01672294
Other Study ID Numbers:
- IIR 11-347
First Posted:
Aug 24, 2012
Last Update Posted:
Apr 17, 2017
Last Verified:
Mar 1, 2017