Trial Outcomes & Findings for Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness (NCT NCT01672294)
NCT ID: NCT01672294
Last Updated: 2017-04-17
Results Overview
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 ).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
286 participants
Primary outcome timeframe
Measured at baseline, 5 weeks, and 8 weeks
Results posted on
2017-04-17
Participant Flow
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.
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.
Participant milestones
| Measure |
Caregiver Outlook - Caregiver
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.
|
Caregiver Outlook - Patient
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.
|
Relaxation Meditation - Caregiver
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
Relaxation Meditation - Patient
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
72
|
72
|
|
Overall Study
COMPLETED
|
65
|
50
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
6
|
21
|
11
|
13
|
Reasons for withdrawal
| Measure |
Caregiver Outlook - Caregiver
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.
|
Caregiver Outlook - Patient
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.
|
Relaxation Meditation - Caregiver
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
Relaxation Meditation - Patient
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
4
|
4
|
|
Overall Study
Excluded by study
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
16
|
7
|
9
|
Baseline Characteristics
Primary diagnosis of veteran only collected from patient half of dyad, which =143
Baseline characteristics by cohort
| Measure |
Caregiver Outlook - Caregiver
n=71 Participants
Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
|
Caregiver Outlook - Patient
n=71 Participants
Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
|
Relaxation Meditation - Caregiver
n=72 Participants
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
Relaxation Meditation - Patient
n=72 Participants
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.32 • n=71 Participants
|
66.8 years
STANDARD_DEVIATION 7.85 • n=71 Participants
|
60.1 years
STANDARD_DEVIATION 12.05 • n=72 Participants
|
65.4 years
STANDARD_DEVIATION 9.21 • n=72 Participants
|
63.3 years
STANDARD_DEVIATION 10.59 • n=286 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=71 Participants
|
4 Participants
n=71 Participants
|
67 Participants
n=72 Participants
|
3 Participants
n=72 Participants
|
141 Participants
n=286 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=71 Participants
|
67 Participants
n=71 Participants
|
5 Participants
n=72 Participants
|
69 Participants
n=72 Participants
|
145 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=71 Participants
|
2 Participants
n=71 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
7 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=71 Participants
|
69 Participants
n=71 Participants
|
68 Participants
n=72 Participants
|
72 Participants
n=72 Participants
|
277 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=286 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=71 Participants
|
29 Participants
n=71 Participants
|
30 Participants
n=72 Participants
|
32 Participants
n=72 Participants
|
122 Participants
n=286 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=71 Participants
|
38 Participants
n=71 Participants
|
33 Participants
n=72 Participants
|
38 Participants
n=72 Participants
|
145 Participants
n=286 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=71 Participants
|
4 Participants
n=71 Participants
|
7 Participants
n=72 Participants
|
2 Participants
n=72 Participants
|
17 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=286 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=71 Participants
|
71 participants
n=71 Participants
|
72 participants
n=72 Participants
|
72 participants
n=72 Participants
|
286 participants
n=286 Participants
|
|
Dyad Relationship
Spouse
|
52 Participants
n=71 Participants
|
52 Participants
n=71 Participants
|
53 Participants
n=72 Participants
|
53 Participants
n=72 Participants
|
210 Participants
n=286 Participants
|
|
Dyad Relationship
Adult Child
|
6 Participants
n=71 Participants
|
2 Participants
n=71 Participants
|
3 Participants
n=72 Participants
|
1 Participants
n=72 Participants
|
12 Participants
n=286 Participants
|
|
Dyad Relationship
Sibling
|
3 Participants
n=71 Participants
|
3 Participants
n=71 Participants
|
3 Participants
n=72 Participants
|
3 Participants
n=72 Participants
|
12 Participants
n=286 Participants
|
|
Dyad Relationship
Parent
|
2 Participants
n=71 Participants
|
6 Participants
n=71 Participants
|
1 Participants
n=72 Participants
|
3 Participants
n=72 Participants
|
12 Participants
n=286 Participants
|
|
Dyad Relationship
Other
|
8 Participants
n=71 Participants
|
8 Participants
n=71 Participants
|
12 Participants
n=72 Participants
|
12 Participants
n=72 Participants
|
40 Participants
n=286 Participants
|
|
Primary Diagnosis of Veteran
Cancer
|
—
|
43 Participants
n=71 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
—
|
52 Participants
n=72 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
95 Participants
n=143 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
|
Primary Diagnosis of Veteran
Congestive Heart Failure
|
—
|
6 Participants
n=71 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
—
|
6 Participants
n=72 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
12 Participants
n=143 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
|
Primary Diagnosis of Veteran
Chronic obstructive pulmonary disease
|
—
|
12 Participants
n=71 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
—
|
5 Participants
n=72 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
17 Participants
n=143 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
|
Primary Diagnosis of Veteran
End Stage Renal Disease
|
—
|
6 Participants
n=71 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
—
|
6 Participants
n=72 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
12 Participants
n=143 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
|
Primary Diagnosis of Veteran
Multiple Qualifying Disease
|
—
|
4 Participants
n=71 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
—
|
3 Participants
n=72 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
7 Participants
n=143 Participants • Primary diagnosis of veteran only collected from patient half of dyad, which =143
|
|
Education
HS or less
|
34 Participants
n=71 Participants
|
33 Participants
n=71 Participants
|
28 Participants
n=72 Participants
|
31 Participants
n=72 Participants
|
126 Participants
n=286 Participants
|
|
Education
Some College
|
22 Participants
n=71 Participants
|
25 Participants
n=71 Participants
|
31 Participants
n=72 Participants
|
29 Participants
n=72 Participants
|
107 Participants
n=286 Participants
|
|
Education
College Degree
|
12 Participants
n=71 Participants
|
6 Participants
n=71 Participants
|
5 Participants
n=72 Participants
|
6 Participants
n=72 Participants
|
29 Participants
n=286 Participants
|
|
Education
Graduate Work or Degree
|
3 Participants
n=71 Participants
|
7 Participants
n=71 Participants
|
8 Participants
n=72 Participants
|
6 Participants
n=72 Participants
|
24 Participants
n=286 Participants
|
|
Finances
Difficulty paying bills
|
10 Participants
n=71 Participants
|
13 Participants
n=71 Participants
|
6 Participants
n=72 Participants
|
6 Participants
n=72 Participants
|
35 Participants
n=286 Participants
|
|
Finances
Money to pay bills, cut back on things
|
13 Participants
n=71 Participants
|
14 Participants
n=71 Participants
|
22 Participants
n=72 Participants
|
13 Participants
n=72 Participants
|
62 Participants
n=286 Participants
|
|
Finances
Enough to pay bills, little extras
|
26 Participants
n=71 Participants
|
22 Participants
n=71 Participants
|
23 Participants
n=72 Participants
|
30 Participants
n=72 Participants
|
101 Participants
n=286 Participants
|
|
Finances
enough to pay bills and special things
|
22 Participants
n=71 Participants
|
22 Participants
n=71 Participants
|
21 Participants
n=72 Participants
|
22 Participants
n=72 Participants
|
87 Participants
n=286 Participants
|
|
Finances
Missing
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=72 Participants
|
1 Participants
n=286 Participants
|
|
Employment
Working Full or Part Time
|
21 Participants
n=71 Participants
|
1 Participants
n=71 Participants
|
19 Participants
n=72 Participants
|
4 Participants
n=72 Participants
|
45 Participants
n=286 Participants
|
|
Employment
Retired/Not Working
|
43 Participants
n=71 Participants
|
38 Participants
n=71 Participants
|
42 Participants
n=72 Participants
|
40 Participants
n=72 Participants
|
163 Participants
n=286 Participants
|
|
Employment
Disabled
|
7 Participants
n=71 Participants
|
32 Participants
n=71 Participants
|
10 Participants
n=72 Participants
|
28 Participants
n=72 Participants
|
77 Participants
n=286 Participants
|
|
Employment
Other
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=286 Participants
|
|
Self-rated Quality of Health
Excellent
|
0 Participants
n=71 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=286 Participants
|
|
Self-rated Quality of Health
Very Good
|
10 Participants
n=71 Participants
|
1 Participants
n=71 Participants
|
13 Participants
n=72 Participants
|
4 Participants
n=72 Participants
|
28 Participants
n=286 Participants
|
|
Self-rated Quality of Health
Good
|
16 Participants
n=71 Participants
|
11 Participants
n=71 Participants
|
14 Participants
n=72 Participants
|
8 Participants
n=72 Participants
|
49 Participants
n=286 Participants
|
|
Self-rated Quality of Health
Fair
|
9 Participants
n=71 Participants
|
14 Participants
n=71 Participants
|
9 Participants
n=72 Participants
|
14 Participants
n=72 Participants
|
46 Participants
n=286 Participants
|
|
Self-rated Quality of Health
Poor
|
0 Participants
n=71 Participants
|
9 Participants
n=71 Participants
|
0 Participants
n=72 Participants
|
12 Participants
n=72 Participants
|
21 Participants
n=286 Participants
|
|
Self-rated Quality of Health
Missing
|
36 Participants
n=71 Participants
|
36 Participants
n=71 Participants
|
35 Participants
n=72 Participants
|
34 Participants
n=72 Participants
|
141 Participants
n=286 Participants
|
|
Years of caregiving given or received
|
4.6 years
STANDARD_DEVIATION 5.6 • n=71 Participants
|
5.2 years
STANDARD_DEVIATION 5.95 • n=71 Participants
|
3.7 years
STANDARD_DEVIATION 4.06 • n=72 Participants
|
3.4 years
STANDARD_DEVIATION 4.2 • n=72 Participants
|
4.2 years
STANDARD_DEVIATION 5.04 • n=286 Participants
|
|
Number of Hours patient requires assistance
|
2.4 hours
STANDARD_DEVIATION 1.24 • n=71 Participants
|
2.3 hours
STANDARD_DEVIATION 1.34 • n=71 Participants
|
2.3 hours
STANDARD_DEVIATION 1.2 • n=72 Participants
|
2.1 hours
STANDARD_DEVIATION 1.25 • n=72 Participants
|
2.3 hours
STANDARD_DEVIATION 1.26 • n=286 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.
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 ).
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=71 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=71 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Caregiver Anxiety
Baseline
|
6.9 units on a scale
Standard Deviation 5.3
|
7.3 units on a scale
Standard Deviation 4.6
|
|
Caregiver Anxiety
5 week follow up
|
5.9 units on a scale
Standard Deviation 5.2
|
5.4 units on a scale
Standard Deviation 4.9
|
|
Caregiver Anxiety
8 week follow up
|
5.8 units on a scale
Standard Deviation 5.7
|
6.4 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.
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).
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=71 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=72 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Spirituality
Baseline
|
35.4 units on a scale
Standard Deviation 9.0
|
37.3 units on a scale
Standard Deviation 7.2
|
|
Spirituality
5 week
|
36.1 units on a scale
Standard Deviation 8.0
|
37.3 units on a scale
Standard Deviation 7.0
|
|
Spirituality
8 week
|
37.3 units on a scale
Standard Deviation 8.3
|
36.6 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.
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
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=71 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=72 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Depression
7 weeks
|
8.3 units on a scale
Standard Deviation 6.2
|
9.0 units on a scale
Standard Deviation 6.4
|
|
Depression
Baseline
|
8.2 units on a scale
Standard Deviation 6.6
|
8.8 units on a scale
Standard Deviation 5.5
|
|
Depression
5 weeks
|
8.7 units on a scale
Standard Deviation 6.8
|
8.0 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: In the 6 months after randomizationThe 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.
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=71 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=72 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Patient Days of VA Hospital Use
|
4.4 Days in VA hospital or ER
Standard Deviation 11.8
|
4.4 Days in VA hospital or ER
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=70 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=70 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Caregiver Burden
Baseline
|
4.2 units on a scale
Standard Deviation 0.6
|
4.2 units on a scale
Standard Deviation 0.6
|
|
Caregiver Burden
5 week
|
4.2 units on a scale
Standard Deviation 0.6
|
4.2 units on a scale
Standard Deviation 0.6
|
|
Caregiver Burden
8 week
|
4.2 units on a scale
Standard Deviation 0.6
|
4.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=70 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=71 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Caregiver Completion
Baseline
|
2.7 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 0.8
|
|
Caregiver Completion
5 Week
|
2.5 units on a scale
Standard Deviation 0.9
|
2.6 units on a scale
Standard Deviation 0.9
|
|
Caregiver Completion
8 Week
|
2.5 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=71 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=72 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Prolonged Grief - Number of Participants With Anticipatory Grief
Baseline
|
6 participants
|
2 participants
|
|
Prolonged Grief - Number of Participants With Anticipatory Grief
5 week
|
2 participants
|
3 participants
|
|
Prolonged Grief - Number of Participants With Anticipatory Grief
8 week
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Measured at baseline, 5 weeks, and 8 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Caregiver Outlook - Caregiver
n=36 Participants
Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
|
Relaxation Meditation - Caregiver
n=37 Participants
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
|
|---|---|---|
|
Caregiver Preparation
Baseline
|
2.7 units on a scale
Standard Deviation 0.7
|
2.4 units on a scale
Standard Deviation 0.8
|
|
Caregiver Preparation
5 Week
|
2.4 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.7
|
|
Caregiver Preparation
8 Week
|
2.6 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 0.8
|
Adverse Events
Caregiver Outlook - Caregiver
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Caregiver Outlook - Patient
Serious events: 13 serious events
Other events: 7 other events
Deaths: 0 deaths
Relaxation Meditation - Caregiver
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Relaxation Meditation - Patient
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caregiver Outlook - Caregiver
n=71 participants at risk
Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.
|
Caregiver Outlook - Patient
n=71 participants at risk
Patients of the caregivers in the Outlook Intervention arm.
|
Relaxation Meditation - Caregiver
n=72 participants at risk
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
Relaxation Meditation - Patient
n=72 participants at risk
Patients of the caregivers in the Attention Control arm.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac
|
0.00%
0/71 • 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.
|
2.8%
2/71 • Number of events 2 • 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.
|
0.00%
0/72 • 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.
|
2.8%
2/72 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Gastro-Intestinal
|
0.00%
0/71 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
0.00%
0/72 • 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.
|
0.00%
0/72 • 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.
|
|
Infections and infestations
Infection
|
0.00%
0/71 • 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.
|
2.8%
2/71 • Number of events 2 • 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.
|
0.00%
0/72 • 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.
|
1.4%
1/72 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/71 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/72 • 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.
|
1.4%
1/72 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/71 • 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.
|
4.2%
3/71 • Number of events 6 • 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.
|
0.00%
0/72 • 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.
|
4.2%
3/72 • Number of events 5 • 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.
|
|
Renal and urinary disorders
Renal
|
0.00%
0/71 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
0.00%
0/72 • 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.
|
1.4%
1/72 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.00%
0/71 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
0.00%
0/72 • 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.
|
1.4%
1/72 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/71 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
0.00%
0/72 • 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.
|
0.00%
0/72 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm-death
|
0.00%
0/71 • 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.
|
5.6%
4/71 • Number of events 4 • 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.
|
0.00%
0/72 • 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.
|
4.2%
3/72 • Number of events 3 • 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.
|
Other adverse events
| Measure |
Caregiver Outlook - Caregiver
n=71 participants at risk
Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.
|
Caregiver Outlook - Patient
n=71 participants at risk
Patients of the caregivers in the Outlook Intervention arm.
|
Relaxation Meditation - Caregiver
n=72 participants at risk
Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
|
Relaxation Meditation - Patient
n=72 participants at risk
Patients of the caregivers in the Attention Control arm.
|
|---|---|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/71 • 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.
|
2.8%
2/71 • Number of events 2 • 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.
|
0.00%
0/72 • 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.
|
9.7%
7/72 • Number of events 7 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/71 • 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.
|
7.0%
5/71 • Number of events 5 • 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.
|
0.00%
0/72 • 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.
|
4.2%
3/72 • Number of events 5 • 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.
|
|
Psychiatric disorders
Psychiatric
|
5.6%
4/71 • Number of events 6 • 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.
|
0.00%
0/71 • 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.
|
5.6%
4/72 • Number of events 5 • 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.
|
0.00%
0/72 • 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.
|
|
Vascular disorders
Vascular/blood
|
0.00%
0/71 • 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.
|
7.0%
5/71 • Number of events 6 • 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.
|
0.00%
0/72 • 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.
|
1.4%
1/72 • Number of events 1 • 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.
|
|
General disorders
Multiple/general
|
0.00%
0/71 • 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.
|
5.6%
4/71 • Number of events 4 • 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.
|
0.00%
0/72 • 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.
|
2.8%
2/72 • Number of events 2 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place