Trial Outcomes & Findings for At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's (NCT NCT04512040)
NCT ID: NCT04512040
Last Updated: 2023-06-15
Results Overview
% of classes attended in 12 weeks of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
AD Patients
Yoga will be delivered in either a 1-on-1 format or a group format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
Caregivers
Yoga will be delivered in either a 1-on-1 format or a group format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 caregiver did not provide their age at baseline
Baseline characteristics by cohort
| Measure |
AD Patients
n=15 Participants
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
Caregivers
n=15 Participants
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.33 Years
STANDARD_DEVIATION 9.79 • n=15 Participants • 1 caregiver did not provide their age at baseline
|
63.86 Years
STANDARD_DEVIATION 9.31 • n=14 Participants • 1 caregiver did not provide their age at baseline
|
68.60 Years
STANDARD_DEVIATION 9.55 • n=29 Participants • 1 caregiver did not provide their age at baseline
|
|
Sex: Female, Male
Female
|
10 Participants
n=13 Participants • Number of analyzed in rows differ from overall number due to no responses by some participants.
|
10 Participants
n=14 Participants • Number of analyzed in rows differ from overall number due to no responses by some participants.
|
20 Participants
n=27 Participants • Number of analyzed in rows differ from overall number due to no responses by some participants.
|
|
Sex: Female, Male
Male
|
3 Participants
n=13 Participants • Number of analyzed in rows differ from overall number due to no responses by some participants.
|
4 Participants
n=14 Participants • Number of analyzed in rows differ from overall number due to no responses by some participants.
|
7 Participants
n=27 Participants • Number of analyzed in rows differ from overall number due to no responses by some participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
24 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
3 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 12 weeks% of classes attended in 12 weeks of treatment
Outcome measures
| Measure |
AD Patients
n=14 Participants
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
Caregivers
n=14 Participants
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
|---|---|---|
|
Attendance
|
85.12 percentage of classes attended
Standard Deviation 15.75
|
86.31 percentage of classes attended
Standard Deviation 15.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately after the final treatment session (1 day)Population: 1 dyad dropped out during intervention, 1 dyad lost to follow up after intervention (total of 13 dyads completed outcome measures)
Satisfaction of treatment was measured using the Multi-Dimensional Treatment Satisfaction Measure (MDTSM), which is composed of 33 questions that assess treatment process and outcome attributes. Each of the 33 questions is scored on a zero to 4 Likert rating scale with a score of zero indicating "not at all satisfied" and a score of 4 indicating "very satisfied". For each participant the mean score from all 33 ratings is calculated, which produces a score ranging from zero (not at all satisfied) to 4 (very satisfied). For the assessment of feasibility, we set the group mean target score on the MDTSM to ≥2, representing neutral or positive satisfaction.
Outcome measures
| Measure |
AD Patients
n=13 Participants
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
Caregivers
n=13 Participants
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
|
|---|---|---|
|
Treatment Satisfaction: Questionnaire
|
3.01 score on a scale
Standard Deviation 0.69
|
3.30 score on a scale
Standard Deviation 0.63
|
Adverse Events
AD Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place