search
Back to results

Caring Relationships Expression Study (CARES)

Primary Purpose

Caregiver Burden, Anxiety, Stress

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Heart Rate Variability Biofeedback
Music Listening Control
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Burden focused on measuring Heart Rate Variability, Biofeedback, Alzheimer's disease, Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: In primary/unpaid FCG role > 6 months Caring for mild-to-severe ADRD patient 4 caregiver burden score Own/operate smartphone w data plan Exclusion Criteria: Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback

Sites / Locations

  • Arizona State University Downtown CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Music Listening Control

Heart Rate Variability Biofeedback

Arm Description

Music listening control (MLC) will consist of listening to selected music tracks of choice using either the Pandora or Spotify app (with coaching to download app and play, and log listening time in diary), specifically choosing a neutral channel, Coffeehouse Playlist. For both interventions, FCG will be asked to practice/listen 10-minutes at a time with their AD patient (sharing as much or as little as is possible/preferred) for at least 4-5 days/week, and asked to complete diary/checklists to show times practicing/listening.

Participants will receive coaching in a practice that is guided using an Inner Balance app with a device that senses pulse and provides feedback to help achieve a rhythm of heart rate variability called resonant frequency, or "coherence". They will be guided first in slowed heart-focused breathing and positively-focused emotions and then will connect to the app to receives visual feedback to achieve a favorable HRV.

Outcomes

Primary Outcome Measures

Perceived Stress Scale-10 (PSS-10)
10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress
Caregiver Burden
The Zarit Burden Interview includes 12 items, scoring from 0 to 4 (total range 0 to 48) with higher scores indicating higher perceived caregiver Burden

Secondary Outcome Measures

The Brief Resilience Scale
The Brief Resilience Scale includes 4 items scoring 1-5, total score range, 4-20 with higher scores indicating higher resilience
Self-Compassion Scale
Self-Compassion Scale contains 12 items scoring 1-5, total score range, 12-60 with higher scores indicating higher self-compassion
Relationship Quality
Relationship Quality for caregivers and their caregivee is assessed using 4 items scoring 1-4, total range, 5-20 with higher scores indicating better quality
Depression
Patient Health Questionnaire-4 (PHQ4) using 4 items scoring 0-3, total range 0-12 with higher scores indicating poor mood

Full Information

First Posted
November 16, 2022
Last Updated
January 4, 2023
Sponsor
Arizona State University
search

1. Study Identification

Unique Protocol Identification Number
NCT05627687
Brief Title
Caring Relationships Expression Study
Acronym
CARES
Official Title
Caring Relationships Expression Study (CARES)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
Yes

5. Study Description

Brief Summary
This study will examine a heart rate variability biofeedback (HRVB) intervention versus a music listening control (MLC) for 30 family caregivers (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 over the course of 8-weeks.
Detailed Description
This pilot study aims to examine feasibility of implementing a HRVB intervention and an MLC control with AD FCGs. The HRVB and MLC interventions will be evaluated for acceptability (operationalized as adherence to intervention) and satisfaction and to identify necessary intervention modifications. Feasibility benchmarks: 85% of participants will be at least 70% adherent to implementation goals (10-min use 5-7 days per week). Feasibility of randomization will be examined by comparing adherence/retention (expecting similar patterns across interventions). Acceptability/satisfaction with HRVB and MLC will be evaluated in semi-structured interviews post-intervention including detailed probing on feature preferences, barriers/facilitators, suggested improvements for retention. The second aim of this study is to examine patterns of association of HRVB and MLC with outcomes. The investigators will examine pre- to post-intervention changes (and sustained outcomes at follow-up) in self-reported caregiver burden, stress and resilience. Change in relationship quality will additionally be assessed from pre- to post intervention. Change in ANS balance, a neurophysiological indicator of reduced emotional distress and improved resilience, will be assessed using HRV data at all four timepoints to examine trends and change over time. Significance tests will not be conducted, in alignment with goals for pilot feasibility studies. The investigators will observe the direction of change and outcomes to examine the value of MLC as an appropriate control condition showing minimal placebo effects compared to HRVB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Anxiety, Stress
Keywords
Heart Rate Variability, Biofeedback, Alzheimer's disease, Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a two-arm parallel randomized controlled trial comparing heart rate variability biofeedback to a music listening control condition, both practiced 4-5 days per week for 8 weeks.
Masking
Participant
Masking Description
The participant is advised that they are entering a study in which they will be randomized to one of two conditions designed to potentially reduce stress and caregiver burden. Neither condition is presented as the control, thus participants are blinded to the expectations of the assigned condition.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Listening Control
Arm Type
Placebo Comparator
Arm Description
Music listening control (MLC) will consist of listening to selected music tracks of choice using either the Pandora or Spotify app (with coaching to download app and play, and log listening time in diary), specifically choosing a neutral channel, Coffeehouse Playlist. For both interventions, FCG will be asked to practice/listen 10-minutes at a time with their AD patient (sharing as much or as little as is possible/preferred) for at least 4-5 days/week, and asked to complete diary/checklists to show times practicing/listening.
Arm Title
Heart Rate Variability Biofeedback
Arm Type
Active Comparator
Arm Description
Participants will receive coaching in a practice that is guided using an Inner Balance app with a device that senses pulse and provides feedback to help achieve a rhythm of heart rate variability called resonant frequency, or "coherence". They will be guided first in slowed heart-focused breathing and positively-focused emotions and then will connect to the app to receives visual feedback to achieve a favorable HRV.
Intervention Type
Behavioral
Intervention Name(s)
Heart Rate Variability Biofeedback
Other Intervention Name(s)
Heart Focused breathing
Intervention Description
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
Intervention Type
Behavioral
Intervention Name(s)
Music Listening Control
Intervention Description
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
Primary Outcome Measure Information:
Title
Perceived Stress Scale-10 (PSS-10)
Description
10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress
Time Frame
Change from baseline to 8 weeks at end of intervention
Title
Caregiver Burden
Description
The Zarit Burden Interview includes 12 items, scoring from 0 to 4 (total range 0 to 48) with higher scores indicating higher perceived caregiver Burden
Time Frame
Change from baseline to 8 weeks at end of intervention
Secondary Outcome Measure Information:
Title
The Brief Resilience Scale
Description
The Brief Resilience Scale includes 4 items scoring 1-5, total score range, 4-20 with higher scores indicating higher resilience
Time Frame
Change from baseline to 8 weeks at end of intervention
Title
Self-Compassion Scale
Description
Self-Compassion Scale contains 12 items scoring 1-5, total score range, 12-60 with higher scores indicating higher self-compassion
Time Frame
Change from baseline to 8 weeks at end of intervention
Title
Relationship Quality
Description
Relationship Quality for caregivers and their caregivee is assessed using 4 items scoring 1-4, total range, 5-20 with higher scores indicating better quality
Time Frame
Change from baseline to 8 weeks at end of intervention
Title
Depression
Description
Patient Health Questionnaire-4 (PHQ4) using 4 items scoring 0-3, total range 0-12 with higher scores indicating poor mood
Time Frame
Change from baseline to 8 weeks at end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In primary/unpaid FCG role > 6 months Caring for mild-to-severe ADRD patient 4 caregiver burden score Own/operate smartphone w data plan Exclusion Criteria: Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda K Larkey, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University Downtown Campus
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
Darith L James, MS
Phone
207-479-1440
Email
dara.james@asu.edu
First Name & Middle Initial & Last Name & Degree
Linda K Larkey, PhD
Phone
602-496-0740
Email
linda.larkey@asu.edu

12. IPD Sharing Statement

Learn more about this trial

Caring Relationships Expression Study

We'll reach out to this number within 24 hrs