Trial Outcomes & Findings for Online Education and Gentle Exercise Intervention (NCT NCT03440320)
NCT ID: NCT03440320
Last Updated: 2025-06-13
Results Overview
Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference. Caregiver and care receiver completed the assessment on their own pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Administered at baseline and again following the 8-week intervention
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
MY-Skills Intervention - Online
MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
|
MY-Plan Control - Online
MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
|
Overall Study
COMPLETED
|
18
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
MY-Skills Intervention - Online
MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
|
MY-Plan Control - Online
MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
unreported data from one participant
Baseline characteristics by cohort
| Measure |
Online Pilot, MY-Skills (Intervention), Caregivers
n=9 Participants
Participants in the MY-Skills program who provide the most care to their partner (other member of the dyad).
|
Online Pilot, MY-Skills (Intervention), Care Receivers
n=9 Participants
Participants in the MY-Skills program who receive the most care from their partner (other member of the dyad).
|
Online Pilot, MY-PLAN (Control), Caregivers
n=7 Participants
Participants in the MY-PLAN control group who provide the most care to their partner (other member of the dyad).
|
Online Pilot, MY-PLAN (Control), Care Receivers
n=7 Participants
Participants in the MY-PLAN control group who receive the most care from their partner (other member of the dyad).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.33 years
STANDARD_DEVIATION 20.72 • n=9 Participants
|
65.00 years
STANDARD_DEVIATION 18.97 • n=9 Participants
|
37.57 years
STANDARD_DEVIATION 12.73 • n=7 Participants
|
39.86 years
STANDARD_DEVIATION 21.04 • n=7 Participants
|
52.19 years
STANDARD_DEVIATION 21.68 • n=32 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants • unreported data from one participant
|
8 Participants
n=9 Participants • unreported data from one participant
|
1 Participants
n=7 Participants • unreported data from one participant
|
6 Participants
n=6 Participants • unreported data from one participant
|
21 Participants
n=31 Participants • unreported data from one participant
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants • unreported data from one participant
|
1 Participants
n=9 Participants • unreported data from one participant
|
6 Participants
n=7 Participants • unreported data from one participant
|
0 Participants
n=6 Participants • unreported data from one participant
|
10 Participants
n=31 Participants • unreported data from one participant
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=32 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=32 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=32 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=32 Participants
|
|
PROMIS-29 Profile v2
|
78.56 units on a scale
STANDARD_DEVIATION 12.05 • n=9 Participants • unreported data from one participant
|
80.22 units on a scale
STANDARD_DEVIATION 16.08 • n=9 Participants • unreported data from one participant
|
69.17 units on a scale
STANDARD_DEVIATION 12.47 • n=6 Participants • unreported data from one participant
|
88.57 units on a scale
STANDARD_DEVIATION 3.95 • n=7 Participants • unreported data from one participant
|
79.48 units on a scale
STANDARD_DEVIATION 13.33 • n=31 Participants • unreported data from one participant
|
PRIMARY outcome
Timeframe: Administered at baseline and again following the 8-week interventionChange from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference. Caregiver and care receiver completed the assessment on their own pain.
Outcome measures
| Measure |
Online Pilot, MY-Skills (Intervention), Caregivers
n=9 Participants
Participants in the MY-Skills program who provide the most care to their partner (other member of the dyad).
|
Online Pilot, MY-Skills (Intervention), Care Receivers
n=8 Participants
Participants in the MY-Skills program who receive the most care from their partner (other member of the dyad).
|
Online Pilot, MY-PLAN (Control), Caregivers
n=6 Participants
Participants in the MY-PLAN control group who provide the most care to their partner (other member of the dyad).
|
Online Pilot, MY-PLAN (Control), Care Receivers
n=7 Participants
Participants in the MY-PLAN control group who receive the most care from their partner (other member of the dyad).
|
|---|---|---|---|---|
|
Brief Pain Inventory
|
0.23 Change in score of units on a scale
Standard Deviation 1.34
|
-0.29 Change in score of units on a scale
Standard Deviation 1.63
|
-1.38 Change in score of units on a scale
Standard Deviation 1.83
|
-1.32 Change in score of units on a scale
Standard Deviation 1.87
|
Adverse Events
MY-Skills Intervention - Online
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
MY-Plan Control - Online
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MY-Skills Intervention - Online
n=18 participants at risk
MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
|
MY-Plan Control - Online
n=14 participants at risk
MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Extreme leg pain
|
0.00%
0/18 • 9 months, the span of time we conducted every intervention cohort
Serious adverse event information collected and evaluated by our Institutional Review Board.
|
7.1%
1/14 • Number of events 1 • 9 months, the span of time we conducted every intervention cohort
Serious adverse event information collected and evaluated by our Institutional Review Board.
|
|
Cardiac disorders
High blood pressure
|
5.6%
1/18 • Number of events 1 • 9 months, the span of time we conducted every intervention cohort
Serious adverse event information collected and evaluated by our Institutional Review Board.
|
0.00%
0/14 • 9 months, the span of time we conducted every intervention cohort
Serious adverse event information collected and evaluated by our Institutional Review Board.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place