Overview
This study will evaluate whether a nurse-led heart rate variability (HRV) biofeedback programme supported by a low-cost wearable sensor reduces autonomic dysregulation and perceived stress in informal caregivers of people with dementia. Participants will be prospectively allocated, without randomization, at the day-care-centre level. Before enrolment, the six centres will be characterised according to centre size, estimated number of eligible caregivers and expected recruitment volume, and arranged into three approximately matched pairs. One centre in each pair will implement CARE-COHERENCE and the other will serve as a concurrent comparison centre under a pre-specified operational implementation plan. Follow-up will continue for 12 months.
Description
Approximately 100 informal caregivers of older people with dementia attending one of six participating day-care centres will be enrolled. The intervention group will receive an 8-week HRV-biofeedback programme in addition to usual caregiver support. The comparison group will receive usual caregiver support during the 12-month study period and will be offered access to programme materials after completion of the final assessment. The primary outcome is change in resting root mean square of successive differences (RMSSD) from baseline to 6 months. Perceived stress is the key secondary outcome. Assessments occur at baseline, 8 weeks, 6 months and 12 months.
Eligibility
Inclusion Criteria:
- Adult (18 years or older) self-identified informal, unpaid caregiver of an older person with a clinical diagnosis of dementia attending one of the participating day-care centers.
- Providing an average of at least 28 hours of unpaid care per week for a minimum of 3 months.
- Able to understand study procedures and provide written informed consent.
- Able to use a smartphone and a simple wearable device, independently or with brief study support.
Exclusion Criteria:
- Persistent or clinically significant cardiac arrhythmia preventing reliable interbeat-interval analysis.
- Pacemaker-dependent rhythm or another condition that, in the investigator's judgment, precludes valid heart rate variability assessment.
- Current participation in formal heart rate variability biofeedback or structured resonance-frequency breathing training, or equivalent training within the previous 3 months.
- Severe uncontrolled psychiatric illness or cognitive impairment precluding informed consent or meaningful participation.
- Concurrent enrollment in another structured stress-reduction intervention trial.
- Note: use of heart rate-modifying medication, including beta-blockers, is not an exclusion criterion. Medication use is documented prospectively and considered in prespecified sensitivity analyses.
