Caring Relationships Expression Study (CARES)

Caring Relationships Expression Study (CARES)

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.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Caregiver Burden
• Intervention / Treatment: Behavioral: Music Listening Control; Behavioral: Heart Rate Variability Biofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University Downtown Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Music Listening Control; 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.	Behavioral: Music Listening Control; Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
Active Comparator: Heart Rate Variability Biofeedback; 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.	Behavioral: Heart Rate Variability Biofeedback; Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week; Other Names: Heart Focused breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale-10 (PSS-10)	10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress	Change from baseline to 8 weeks at end of intervention
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	Change from baseline to 8 weeks at end of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline to 8 weeks at end of intervention
Self-Compassion Scale	Self-Compassion Scale contains 12 items scoring 1-5, total score range, 12-60 with higher scores indicating higher self-compassion	Change from baseline to 8 weeks at end of intervention
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	Change from baseline to 8 weeks at end of intervention
Depression	Patient Health Questionnaire-4 (PHQ4) using 4 items scoring 0-3, total range 0-12 with higher scores indicating poor mood	Change from baseline to 8 weeks at end of intervention

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: Linda K Larkey, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Heart Rate Variability; Dementia; Biofeedback
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 00014913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No