Clinical trial NCT05103839: Yoga for Caregivers and Persons With Dementia
Official title: A Pilot Study Yoga for Caregivers and Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dyad
caregiver
yoga
dementia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accrual Percentage--Persons with Dementia
timeFrame: Baseline
measure: Accrual Percentage--Caregivers
timeFrame: Baseline
measure: Percentage Adherence to Intervention Sessions--Persons with Dementia
timeFrame: Week 10
measure: Percentage Adherence to Intervention Sessions--Caregivers
timeFrame: Week 10
measure: Retention Percentage--Persons With Dementia
timeFrame: Week 10
measure: Retention Percentage--Caregivers
timeFrame: Week 10
Secondary outcomes:
measure: Client Satisfaction Questionnaire--Persons With Dementia
timeFrame: Week 10
measure: Client Satisfaction Questionnaire--Caregivers
timeFrame: Week 10
measure: Zarit Burden Interview
timeFrame: Baseline, Week 10
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia
timeFrame: Baseline, Week 10
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers
timeFrame: Baseline, Week 10
measure: PROMIS Depression--Persons with Dementia
timeFrame: Baseline, Week 10
measure: PROMIS Depression--Caregivers
timeFrame: Baseline, Week 10
measure: PROMIS Self-efficacy for Managing Emotions--Persons with Dementia
timeFrame: Baseline, Week 10
measure: PROMIS Self-efficacy for Managing Emotions--Caregivers
timeFrame: Baseline, Week 10
measure: Neuropsychiatric Inventory Questionnaire--Severity
timeFrame: Baseline, Week 10
measure: Neuropsychiatric Inventory Questionnaire--Distress
timeFrame: Baseline, Week 10
measure: Insomnia Sleep Index--Persons with Dementia
timeFrame: Baseline, Week 10
measure: Insomnia Sleep Index--Caregivers
timeFrame: Baseline, Week 10
Other outcomes:
measure: Percentage Adherence to Independent Practice--Persons With Dementia
timeFrame: Week 10
measure: Percentage Adherence to Independent Practice--Caregivers
timeFrame: Week 10
measure: Qualitative Questions
timeFrame: Baseline, Week 10
measure: Average Minutes of Yoga Practice per Day--Persons With Dementia
timeFrame: From Baseline through Week 10
measure: Average Minutes of Yoga Practice per Day--Caregivers
timeFrame: From Baseline through Week 10
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gretchen Brenes, PhD
role: PRINCIPAL_INVESTIGATOR
References: