Trial Outcomes & Findings for Outlook Quality of Life Intervention (NCT NCT00784095)
NCT ID: NCT00784095
Last Updated: 2016-03-22
Results Overview
Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 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 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline, 6 and 8 week follow up
Results posted on
2016-03-22
Participant Flow
Participant milestones
| Measure |
Preparation and Completion
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outlook Quality of Life Intervention
Baseline characteristics by cohort
| Measure |
Preparation and Completion
n=12 Participants
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=12 Participants
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
n=12 Participants
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
68 years
STANDARD_DEVIATION 10 • n=7 Participants
|
69 years
STANDARD_DEVIATION 14 • n=5 Participants
|
67 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 and 8 week follow upQuality Of Life At The End Of Life (the QUAL-E 2009) is a 31 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 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.
Outcome measures
| Measure |
Preparation and Completion
n=12 Participants
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=11 Participants
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
n=11 Participants
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
|---|---|---|---|
|
Quality of Life - Preparation
Baseline
|
14.4 units on a scale
Standard Deviation 3.9
|
16.0 units on a scale
Standard Deviation 3.7
|
15.4 units on a scale
Standard Deviation 4.4
|
|
Quality of Life - Preparation
6 week follow up
|
15.2 units on a scale
Standard Deviation 3.8
|
14.8 units on a scale
Standard Deviation 5.1
|
14.5 units on a scale
Standard Deviation 3.9
|
|
Quality of Life - Preparation
8 week follow up
|
16.3 units on a scale
Standard Deviation 2.7
|
16.1 units on a scale
Standard Deviation 4.6
|
14.5 units on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Baseline, 6 and 8 week follow upA sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.
Outcome measures
| Measure |
Preparation and Completion
n=12 Participants
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=11 Participants
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
n=11 Participants
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
|---|---|---|---|
|
QUAL-E Completion Sub-scale
Baseline
|
22.4 units on a scale
Standard Deviation 6.5
|
24.5 units on a scale
Standard Deviation 5.2
|
22.5 units on a scale
Standard Deviation 6.9
|
|
QUAL-E Completion Sub-scale
6 week follow up
|
22.6 units on a scale
Standard Deviation 5.6
|
25.3 units on a scale
Standard Deviation 5.2
|
23.1 units on a scale
Standard Deviation 6.1
|
|
QUAL-E Completion Sub-scale
8 week follow up
|
23.4 units on a scale
Standard Deviation 5.6
|
24.1 units on a scale
Standard Deviation 5.9
|
24.4 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, 6 and 8 week follow upsRosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
Outcome measures
| Measure |
Preparation and Completion
n=12 Participants
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=11 Participants
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
n=11 Participants
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
|---|---|---|---|
|
Functional Status ADL
Baseline
|
22.3 units on a scale
Standard Deviation 4.4
|
21.0 units on a scale
Standard Deviation 2.3
|
29.7 units on a scale
Standard Deviation 6.4
|
|
Functional Status ADL
6 week follow up
|
23 units on a scale
Standard Deviation 5.7
|
24 units on a scale
Standard Deviation 8.1
|
30.6 units on a scale
Standard Deviation 8.2
|
|
Functional Status ADL
8 week follow up
|
23.1 units on a scale
Standard Deviation 5.3
|
21.8 units on a scale
Standard Deviation 4.0
|
29.8 units on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, 6 and 8 week follow upCenter for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
Outcome measures
| Measure |
Preparation and Completion
n=12 Participants
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=11 Participants
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
n=11 Participants
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
|---|---|---|---|
|
Center for Epidemiology Studies - Depression Scale (CES-D)
Baseline
|
12.0 units on a scale
Standard Deviation 5.0
|
12.0 units on a scale
Standard Deviation 8.3
|
13.4 units on a scale
Standard Deviation 6.6
|
|
Center for Epidemiology Studies - Depression Scale (CES-D)
6 week follow up
|
12.4 units on a scale
Standard Deviation 5.4
|
12.6 units on a scale
Standard Deviation 7.7
|
12.3 units on a scale
Standard Deviation 6.8
|
|
Center for Epidemiology Studies - Depression Scale (CES-D)
8 week follow up
|
9.4 units on a scale
Standard Deviation 4.2
|
12.5 units on a scale
Standard Deviation 8.9
|
12.1 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, 6 and 8 week follow upsThe anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.
Outcome measures
| Measure |
Preparation and Completion
n=12 Participants
Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=11 Participants
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD.
|
True Control
n=11 Participants
Subjects in the third group ("true control") will be exposed to no intervention or attention control.
|
|---|---|---|---|
|
POMS Anxiety Sub-scale
Baseline
|
5.0 units on a scale
Standard Deviation 5.5
|
4.1 units on a scale
Standard Deviation 4.1
|
5.3 units on a scale
Standard Deviation 4.4
|
|
POMS Anxiety Sub-scale
6 week follow up
|
5.1 units on a scale
Standard Deviation 4.9
|
5.0 units on a scale
Standard Deviation 4.0
|
5.9 units on a scale
Standard Deviation 4.4
|
|
POMS Anxiety Sub-scale
8 week follow up
|
4.6 units on a scale
Standard Deviation 3.3
|
4.8 units on a scale
Standard Deviation 5.4
|
5.3 units on a scale
Standard Deviation 4.2
|
Adverse Events
Preparation and Completion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
True Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preparation and Completion
n=12 participants at risk
Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
Attention Control
n=12 participants at risk
The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects listened to a non-guided relaxation CD.
|
True Control
n=12 participants at risk
Subjects in the third group ("true control") were exposed to no intervention or attention control.
|
|---|---|---|---|
|
General disorders
Death
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen Steinhauser
VA Health Services Research and Development
Phone: 9196682148
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place