Trial Outcomes & Findings for Personal Resilience Empowerment Program Study (NCT NCT03644173)
NCT ID: NCT03644173
Last Updated: 2021-10-15
Results Overview
Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
COMPLETED
NA
37 participants
Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)
2021-10-15
Participant Flow
Participant milestones
| Measure |
Personal Resilience Empowerment Program
Participants who were enrolled and completed all visits
|
|---|---|
|
Participants at Last Visit (Pre-surveys)
STARTED
|
37
|
|
Participants at Last Visit (Pre-surveys)
COMPLETED
|
16
|
|
Participants at Last Visit (Pre-surveys)
NOT COMPLETED
|
21
|
|
Participants at the 1-month Follow up
STARTED
|
16
|
|
Participants at the 1-month Follow up
COMPLETED
|
12
|
|
Participants at the 1-month Follow up
NOT COMPLETED
|
4
|
|
Participants at the 3-month Follow up
STARTED
|
12
|
|
Participants at the 3-month Follow up
COMPLETED
|
10
|
|
Participants at the 3-month Follow up
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Personal Resilience Empowerment Program
Participants who were enrolled and completed all visits
|
|---|---|
|
Participants at Last Visit (Pre-surveys)
Lost to Follow-up
|
21
|
|
Participants at the 1-month Follow up
Lost to Follow-up
|
2
|
|
Participants at the 1-month Follow up
Death
|
2
|
|
Participants at the 3-month Follow up
Lost to Follow-up
|
2
|
Baseline Characteristics
Personal Resilience Empowerment Program Study
Baseline characteristics by cohort
| Measure |
Personal Resilience Empowerment Program
n=16 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
67.68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=16 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
7-8 hours of sleep/day
|
-1.06 scores on a scale
Standard Deviation 1.95
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Waking up rested
|
-0.80 scores on a scale
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=16 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Remaining physically active
|
-0.13 scores on a scale
Standard Deviation 1.78
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Needing help with everyday activities
|
0.56 scores on a scale
Standard Deviation 1.90
|
PRIMARY outcome
Timeframe: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=16 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
|
-0.19 scores on a scale
Standard Deviation 0.66
|
PRIMARY outcome
Timeframe: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=15 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
5-10 servings of fruits/day
|
0.60 scores on a scale
Standard Deviation 1.40
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Avoiding fast food
|
1.00 scores on a scale
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: At 1 month Post intervention (survey was sent at 30 days after the last couching session)Population: Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey
Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre-intervention survey and 1-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=12 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
7-8 hours of sleep/day
|
-0.33 scores on a scale
Standard Deviation 1.23
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Waking up rested
|
0.08 scores on a scale
Standard Deviation 1.16
|
PRIMARY outcome
Timeframe: At 1 month Post intervention (survey was sent at 30 days after the last couching session)Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 1-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=12 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Remaining physically active
|
0.67 scores on a scale
Standard Deviation 1.23
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Needing help with everyday activities
|
-0.08 scores on a scale
Standard Deviation 1.73
|
PRIMARY outcome
Timeframe: At 1 month Post intervention (survey was sent at 30 days after the last couching session)Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 1-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=12 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
|
-0.33 scores on a scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: At 1 month Post intervention (survey was sent at 30 days after the last couching session)Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 1-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=12 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
5-10 servings of fruits/day
|
0.45 scores on a scale
Standard Deviation 1.51
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Avoiding fast food
|
0.36 scores on a scale
Standard Deviation 1.96
|
PRIMARY outcome
Timeframe: At 3 month Post intervention (survey was sent at 90 days after the last couching session)Population: Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey
Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre-intervention survey and 3-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=10 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
7-8 hours of sleep/day
|
-0.63 scores on a scale
Standard Deviation 1.51
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Waking up rested
|
-0.80 scores on a scale
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: At 3 month Post intervention (survey was sent at 90 days after the last couching session)Population: Change in the question regarding activity (t-test) between the pre and the 3-month post intervention survey
Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=10 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Remaining physically active
|
0.70 scores on a scale
Standard Deviation 0.95
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Needing help with everyday activities
|
-0.80 scores on a scale
Standard Deviation 1.48
|
PRIMARY outcome
Timeframe: At 3 month Post intervention (survey was sent at 90 days after the last couching session)Population: Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey
Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=9 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
|
-0.22 scores on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: At 3 month Post intervention (survey was sent at 90 days after the last couching session)Population: Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey
Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=9 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
5-10 servings of fruits/day
|
0.44 scores on a scale
Standard Deviation 1.81
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Avoiding fast food
|
0.89 scores on a scale
Standard Deviation 2.42
|
PRIMARY outcome
Timeframe: Post intervention (survey completed at the end of last coaching session)Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=16 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Adapting to changes
|
0.00 scores on a scale
Standard Deviation 0.63
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Bouncing back from illness/injury and hardship
|
-0.13 scores on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: At 1 month Post intervention (survey was sent at 30 days after the last couching session)Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 1-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=12 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Adapting to changes
|
0.00 scores on a scale
Standard Deviation 0.95
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Bouncing back from illness/injury and hardship
|
-0.36 scores on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: At 3 month Post intervention (survey was sent at 90 days after the last couching session)Population: Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey
Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=9 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Adapting to changes
|
0.00 scores on a scale
Standard Deviation 0.87
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Bouncing back from illness/injury and hardship
|
-0.11 scores on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Post intervention (survey completed at the end of last coaching session)Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=16 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Knowledge to manage own health
|
-0.13 scores on a scale
Standard Deviation 0.52
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Being in control of own health and well-being
|
-0.25 scores on a scale
Standard Deviation 1.13
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Knowing where to turn in times of crisis/stress
|
-0.13 scores on a scale
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: At 1 month Post intervention (survey was sent at 30 days after the last couching session)Population: Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey
Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 1-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=12 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Being in control of own health and well-being
|
-0.33 scores on a scale
Standard Deviation 0.49
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Knowing where to turn in times of crisis/stress
|
-0.25 scores on a scale
Standard Deviation 1.14
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Knowledge to manage own health
|
-0.33 scores on a scale
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: At 3 month Post intervention (survey was sent at 90 days after the last couching session)Population: Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey
Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey
Outcome measures
| Measure |
Personal Resilience Empowerment Program
n=10 Participants
Participants who were enrolled and attended at least one visit
|
|---|---|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Knowledge to manage own health
|
-0.20 scores on a scale
Standard Deviation 0.42
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Being in control of own health and well-being
|
-0.40 scores on a scale
Standard Deviation 0.70
|
|
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Knowing where to turn in times of crisis/stress
|
-0.22 scores on a scale
Standard Deviation 0.83
|
Adverse Events
Personal Resilience Empowerment Program (All Visits and Follow up)
Personal Resilience Empowerment Program (Visits Only)
Serious adverse events
| Measure |
Personal Resilience Empowerment Program (All Visits and Follow up)
n=10 participants at risk
Participants who were enrolled, completed all visits and completed the two follow-up visits (1 month and 3 months post-op)
|
Personal Resilience Empowerment Program (Visits Only)
n=16 participants at risk
Participants who were enrolled and completed the first three visits (but not follow-up)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to underlining cancer
|
0.00%
0/10 • 3 months post-op
Any adverse events related to the Personal Resilience Empowerment Program Study
|
12.5%
2/16 • Number of events 2 • 3 months post-op
Any adverse events related to the Personal Resilience Empowerment Program Study
|
Other adverse events
Adverse event data not reported
Additional Information
Manager, Investigator Initiated Research Program
Hackensack meridian Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place