Back to resultsExamining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study (CARES)
Primary Purpose
Alzheimer's Disease and Related Dementias Family Caregivers
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Listening Control (MLC)
Heart Focused Breathing
Sponsored by
About this trial
This is an interventional other trial for Alzheimer's Disease and Related Dementias Family Caregivers
Eligibility Criteria
Inclusion Criteria:
- 18 years and above
- primary, unpaid family caregiver for ADRD patient for 6 months or more
- owns and operates a smartphone with a data plan
- greater than of equal to 4 on caregiver burden scale
Exclusion Criteria:
- regular mind-body practice
- under 18 years old
- pacemaker
- conditions or medications that interfere with heart rate variability
Sites / Locations
- Arizona State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Music Listening Control(MLC)
Heart Focused Breathing
Arm Description
Outcomes
Primary Outcome Measures
Perceived Stress Scale-10
Measure of stress
Zarit Burden Interview
Measures participant burden
Brief Resilience Scale
Measures participant resillience
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05383027
Brief Title
Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study
Acronym
CARES
Official Title
Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study(CARES)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
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
In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementias Family Caregivers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music Listening Control(MLC)
Arm Type
Active Comparator
Arm Title
Heart Focused Breathing
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Music Listening Control (MLC)
Intervention Description
MLC participants will engage in assigned music listening in the presence of their loved one with ADRD via a selected online platform (pandora or Spotify) for 10 minutes a day 5-7 days a week.
Intervention Type
Behavioral
Intervention Name(s)
Heart Focused Breathing
Intervention Description
Heart-focused breathing participants will engage in heart-focused breathing using the inner balance device (shipped to their home), they will be asked to do this in the presence of their loved one with ADRD for 10 minutes a day 5-7 days per week.
Primary Outcome Measure Information:
Title
Perceived Stress Scale-10
Description
Measure of stress
Time Frame
13 weeks
Title
Zarit Burden Interview
Description
Measures participant burden
Time Frame
13 weeks
Title
Brief Resilience Scale
Description
Measures participant resillience
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and above
primary, unpaid family caregiver for ADRD patient for 6 months or more
owns and operates a smartphone with a data plan
greater than of equal to 4 on caregiver burden scale
Exclusion Criteria:
regular mind-body practice
under 18 years old
pacemaker
conditions or medications that interfere with heart rate variability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda K Larkey, PhD
Phone
6028212366
Email
linda.larkey@asu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dara James, PhD
Phone
2074791440
Email
dara.james@asu.edu
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda K Larkey, PhD
Phone
602-821-2366
Email
linda.larkey@asu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study
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