Clinical trial NCT05627687: Caring Relationships Expression Study
Official title: Caring Relationships Expression Study (CARES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Caregiver Burden
Anxiety
Stress
Keywords: Heart Rate Variability
Biofeedback
Alzheimer's disease
Dementia
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Perceived Stress Scale-10 (PSS-10)
timeFrame: Change from baseline to 8 weeks at end of intervention
measure: Caregiver Burden
timeFrame: Change from baseline to 8 weeks at end of intervention
Secondary outcomes:
measure: The Brief Resilience Scale
timeFrame: Change from baseline to 8 weeks at end of intervention
measure: Self-Compassion Scale
timeFrame: Change from baseline to 8 weeks at end of intervention
measure: Relationship Quality
timeFrame: Change from baseline to 8 weeks at end of intervention
measure: Depression
timeFrame: Change from baseline to 8 weeks at end of intervention
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University Downtown Campus
state: Arizona
Study officials:
affiliation: Arizona State University
name: Linda K Larkey, PhD
role: PRINCIPAL_INVESTIGATOR
References: