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Yoga for Caregivers and Persons With Dementia (YCPD)

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gentle Yoga
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring dyad, caregiver, yoga, dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atrium Health Wake Forest BaptistRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga for Caregivers and Persons With Dementia

Arm Description

Persons With Dementia and their caregivers will participate in up to 20 group yoga classes.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Client Satisfaction Questionnaire--Caregivers
8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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

Full Information

First Posted
October 21, 2021
Last Updated
August 31, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05103839
Brief Title
Yoga for Caregivers and Persons With Dementia
Acronym
YCPD
Official Title
A Pilot Study Yoga for Caregivers and Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dyad, caregiver, yoga, dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga for Caregivers and Persons With Dementia
Arm Type
Experimental
Arm Description
Persons With Dementia and their caregivers will participate in up to 20 group yoga classes.
Intervention Type
Behavioral
Intervention Name(s)
Gentle Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accrual Percentage--Persons with Dementia
Description
Number of people randomized/Number of people approached about the study
Time Frame
Baseline
Title
Accrual Percentage--Caregivers
Description
Number of people randomized/Number of people approached about the study
Time Frame
Baseline
Title
Percentage Adherence to Intervention Sessions--Persons with Dementia
Description
Number of sessions attended/Total number of sessions offered
Time Frame
Week 10
Title
Percentage Adherence to Intervention Sessions--Caregivers
Description
Number of sessions attended/Total number of sessions offered
Time Frame
Week 10
Title
Retention Percentage--Persons With Dementia
Description
Number of people who complete the Week 10 assessment/Total Number Enrolled
Time Frame
Week 10
Title
Retention Percentage--Caregivers
Description
Number of people who complete the Week 10 assessment/Total Number Enrolled
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire--Persons With Dementia
Description
8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Time Frame
Week 10
Title
Client Satisfaction Questionnaire--Caregivers
Description
8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Time Frame
Week 10
Title
Zarit Burden Interview
Description
Completed by caregiver. 22-item measure of caregiver burden. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Time Frame
Baseline, Week 10
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia
Description
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.
Time Frame
Baseline, Week 10
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers
Description
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.
Time Frame
Baseline, Week 10
Title
PROMIS Depression--Persons with Dementia
Description
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.
Time Frame
Baseline, Week 10
Title
PROMIS Depression--Caregivers
Description
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.
Time Frame
Baseline, Week 10
Title
PROMIS Self-efficacy for Managing Emotions--Persons with Dementia
Description
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.
Time Frame
Baseline, Week 10
Title
PROMIS Self-efficacy for Managing Emotions--Caregivers
Description
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.
Time Frame
Baseline, Week 10
Title
Neuropsychiatric Inventory Questionnaire--Severity
Description
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.
Time Frame
Baseline, Week 10
Title
Neuropsychiatric Inventory Questionnaire--Distress
Description
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
Time Frame
Baseline, Week 10
Title
Insomnia Sleep Index--Persons with Dementia
Description
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
Time Frame
Baseline, Week 10
Title
Insomnia Sleep Index--Caregivers
Description
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
Time Frame
Baseline, Week 10
Other Pre-specified Outcome Measures:
Title
Percentage Adherence to Independent Practice--Persons With Dementia
Description
Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)
Time Frame
Week 10
Title
Percentage Adherence to Independent Practice--Caregivers
Description
Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)
Time Frame
Week 10
Title
Qualitative Questions
Description
Completed by caregivers. Any changes they noticed, motivation for engaging in yoga, barriers. Interview responses will be reviewed and common themes will be extracted.
Time Frame
Baseline, Week 10
Title
Average Minutes of Yoga Practice per Day--Persons With Dementia
Description
Collected from self-reported yoga/stretching log
Time Frame
From Baseline through Week 10
Title
Average Minutes of Yoga Practice per Day--Caregivers
Description
Collected from self-reported yoga/stretching log
Time Frame
From Baseline through Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gretchen Brenes, PhD
Phone
336.713.8558
Email
gbrenes@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD
Phone
336-713-8558
Email
gbrenes@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Yoga for Caregivers and Persons With Dementia

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