Caring Relationships Expression Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Caring Relationships Expression Study (CARES)

Conditions
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Caregiver Burden, Anxiety, Stress

Intervention / Treatment
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* Behavioral: Heart Rate Variability Biofeedback
* Behavioral: Music Listening Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Rate Variability, Biofeedback, Alzheimer's disease, Dementia