Yoga for Caregivers and Persons With Dementia

Study Overview
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Brief Summary
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The purpose of this research is to determine the feasibility and acceptability of yoga classes for persons living with dementia (PLWD) and their care partners. A secondary aim of this study is to examine the impact of yoga on caregiver burden.

Detailed Description
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Participants will be recruited from the D-Care Study in dyads. Both the caregiver and person with dementia must agree to participate. Screening will be done either in clinics or by telephone in the participants' homes. The intervention will be conducted in community facilities and participants' homes. The sample size will consist of 10 caregiver/person with dementia dyads. This number was chosen to provide evidence of feasibility of conducting yoga classes with dyads.

Official Title
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A Pilot Study Yoga for Caregivers and Persons With Dementia

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Gentle Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregivers: Providing unpaid care to a family member of friend diagnosed Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD) Persons with dementia: A diagnosis of dementia; live in the community (assisted living facility is allowed); cognitively able to participate in yoga as determined by study staff Exclusion Criteria: Non-English-speaking; and practicing yoga or meditation within the last 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga for Caregivers and Persons With Dementia<br>Persons With Dementia and their caregivers will participate in up to 20 group yoga classes. | Behavioral: Gentle Yoga<br>* Yoga classes are twice a week for up to 10 weeks with a trained yoga instructor at a location in the community. Classes will last up to 75 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual Percentage--Persons with Dementia | Number of people randomized/Number of people approached about the study | Baseline | 
| Accrual Percentage--Caregivers | Number of people randomized/Number of people approached about the study | Baseline | 
| Percentage Adherence to Intervention Sessions--Persons with Dementia | Number of sessions attended/Total number of sessions offered | Week 10 | 
| Percentage Adherence to Intervention Sessions--Caregivers | Number of sessions attended/Total number of sessions offered | Week 10 | 
| Retention Percentage--Persons With Dementia | Number of people who complete the Week 10 assessment/Total Number Enrolled | Week 10 | 
| Retention Percentage--Caregivers | Number of people who complete the Week 10 assessment/Total Number Enrolled | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire--Persons With Dementia | 8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction. | Week 10 | 
| Client Satisfaction Questionnaire--Caregivers | 8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction. | Week 10 | 
| Zarit Burden Interview | Completed by caregiver. 22-item measure of caregiver burden. Scores range from 0 to 88, with higher scores indicating greater caregiver burden. | Baseline, Week 10 | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia | 8-item measure of anxiety symptoms 8-item measure of anxiety symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and standard deviation of 10; higher scores indicate greater severity of anxiety. | Baseline, Week 10 | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers | 8-item measure of anxiety symptoms 8-item measure of anxiety symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10; higher scores indicate greater severity of anxiety. | Baseline, Week 10 | 
| PROMIS Depression--Persons with Dementia | 8-item measure of depressive symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10. higher scores indicate greater severity of depression. | Baseline, Week 10 | 
| PROMIS Depression--Caregivers | 8-item measure of depressive symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10. higher scores indicate greater severity of depression. | Baseline, Week 10 | 
| PROMIS Self-efficacy for Managing Emotions--Persons with Dementia | 8-item measure of emotional regulation. Responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10 higher scores indicate greater self-efficacy. | Baseline, Week 10 | 
| PROMIS Self-efficacy for Managing Emotions--Caregivers | 8-item measure of emotional regulation. Responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10 higher scores indicate greater self-efficacy. | Baseline, Week 10 | 
| Neuropsychiatric Inventory Questionnaire--Severity | Completed by caregivers. Severity and distress from 12 care recipient behavioral symptoms. Severity and distress from 12 care recipient behavioral symptoms are rated. Severity is rated on 3 point Likert scale and scores range from 12-36, with higher scores indicating greater severity. | Baseline, Week 10 | 
| Neuropsychiatric Inventory Questionnaire--Distress | Completed by caregivers. Severity and distress from 12 care recipient behavioral symptoms. Severity and distress from 12 care recipient behavioral symptoms are rated. Distress is rated on a 6 point Likert scale and scores range from 0 to 60, with higher scores indicating greater distress | Baseline, Week 10 | 
| Insomnia Sleep Index--Persons with Dementia | 7-item self-report measure of type and severity of insomnia symptoms. 7-item measure of type and severity of insomnia symptoms; responses are made on a 5-point Likert scale and summed, with higher scores indicating greater insomnia; scores range from 0 to 28 | Baseline, Week 10 | 
| Insomnia Sleep Index--Caregivers | 7-item self-report measure of type and severity of insomnia symptoms. 7-item measure of type and severity of insomnia symptoms; responses are made on a 5-point Likert scale and summed, with higher scores indicating greater insomnia; scores range from 0 to 28 | Baseline, Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyad, caregiver, yoga, dementia