Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study
Authors: Harris Melissa , Van Houtven Courtney , Hastings Susan 
Published: November 2022

Background
People living with dementia (PLWD) and their care partners (dementia caring dyads) are at a heightened risk of experiencing stress-related symptoms and conditions. Yet, many dyadic stress management interventions have had limited uptake by health care systems and in the community. An intervention that combines simple, safe, easy-to-use, nonpharmacologic tools (eg, animatronic social pets, weighted blankets and garments, aromatherapy and bright light therapy devices, acupressure, and massage tools) that can be used in the home may be a promising approach to promote stress management among dementia caring dyads.

Objective
The proposed study aims to develop and user test a dyadic toolkit intervention composed of simple, tangible stress management tools for community-dwelling PLWD and their care partners. This study will also explore the feasibility of collecting several stress-related outcome measures to inform measurement selection for future studies.

Methods
A human-centered design (HCD) approach will be used to increase the likelihood of developing an intervention that will be translatable to real-world settings. This study consists of 2 phases. The first phase will address the discover, define, and design stages of HCD using qualitative focus groups with dementia caring dyads (N=12-16 dyads). Dyadic focus groups (3-4 groups anticipated) will be convened to understand participants’ stress experiences and to co-design a stress management toolkit prototype. Rapid qualitative analysis will be used to analyze focus group data. In phase 2, the toolkit prototype will be user tested for 2 weeks in a new sample to address the validation step of HCD. A within-subjects (n=10 dyads), pre-post design will be used with measures of usability (frequency of toolkit use), feasibility (enrollment and withdrawal rates, adverse events/injuries), and acceptability (satisfaction, benefit) collected via questionnaires (at the end of weeks 1 and 2 of user testing) and focus groups (n=3-4 dyads/group at the end of week 2). The feasibility of collecting participant-reported, stress-related outcomes (neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain) and salivary cortisol as a physiologic measure of stress will be assessed at baseline and after user testing.

Results
This study will yield a working prototype of a stress management toolkit for dementia caring dyads, as well as preliminary data to support the feasibility and acceptability of the intervention. User testing will elucidate areas to refine the prototype and provide data to inform preliminary testing of the intervention. As of September 2022, this study has received institutional ethics board approval with phase 1 recruitment anticipated to begin January 2023.

Conclusions
Few interventions have focused on combining simple, safe, low burden tools to promote stress management among community-dwelling dementia caring dyads. By involving families and exploring feasibility and acceptability at the onset of development, this intervention will have greater potential to be implemented and sustained in the future.

Trial Registration
ClinicalTrials.gov NCT05465551; https://clinicaltrials.gov/ct2/show/NCT05465551

International Registered Report Identifier (IRRID)
PRR1-10.2196/43098