Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia

Caregiver Burnout Clinical Trial

Official title: Evaluating an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia: Health enSuite Caregivers Study

Status Not yet recruiting

Clinical Trial Summary

Health enSuite Caregivers is an e-health program designed to meet some of the most common needs of caregivers of persons with dementia, including information about dementia and dementia care, caregivers' emotional health, formal or informal help received from others. It also recommends specific strategies to promote well-being and provides tools to help caregivers implement these strategies in their everyday lives. Health enSuite Caregivers is available online and as a smartphone app. Its development was informed by reviews of caregivers' needs and existing commercially available apps. A systematic search of commercially available smartphone applications for caregivers found that many apps did not consider each caregiver's unique needs, and were limited to psychoeducational content (no tools for self-management). Furthermore, most existing programs have not been rigorously tested or lack evidence to support their effectiveness.

Clinical Trial Description

As the Canadian population ages, the demand for informal caregivers is expected to increase. Currently, an estimated 8 million Canadians provide unpaid assistance and ongoing care to family members and friends in need of support due to physical, cognitive, or mental health conditions. Challenges associated with being an informal caregiver vary based on a number of factors including how much time is involved, the health of the person being cared for, and the care needs. Although all caregivers may experience distress, caregivers of people with dementia are at especially high risk for psychological distress and poor health outcomes. Nearly half of the individuals who are providing care for someone with dementia experience symptoms of distress. It is important to provide caregivers with information and support so that they can manage these demands without compromising their own well-being. However, existing programs for caregivers are relatively limited. Primary care providers play an important role in supporting caregivers of people with dementia; however, there is a lack of effective, easily accessible programs for primary healthcare providers to recommend to a distressed caregiver of someone with dementia. The investigators developed Health enSuite Caregivers as a potential solution to this problem.

Primary hypothesis: On average participants assigned to the intervention group will report greater wellbeing (emotional and relationship facets) over time compared to participants assigned to the control group. At 3 and 6 months post-randomization emotional and relational well-being is expected to be higher in the intervention group compared to the control group. Secondary hypothesis: Participants assigned to the intervention group will have greater well-being (each specific facet, total well-being) and greater self-efficacy at 3 and 6 months post-randomization compared to participants assigned to the control group.

This project consists of a pragmatic randomized controlled trial (RCT). Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a wait-list control group. Participants in both groups will complete self-assessments, including key outcome measures, at baseline, and 3, and 6 months post-randomization. Participants in the intervention group will receive the full Health enSuite Caregivers program immediately after being randomized to this group. It is designed to offer advice to caregivers of persons with dementia based on an assessment of their specific needs. Topics are divided into five main content areas, which are recommended based on an assessment of the caregivers current challenges and sources of stress. Participants in the control group will be wait-listed and receive only treatment as usual during the study. After their participation is the study has ended, participants in the control group will be given access to the full Health enSuite Caregivers program. ;

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burden
• Caregiver Burnout
• Dementia

• NCT number: NCT04944420
• Study type: Interventional
• Source: IWK Health Centre
• Contact: Rekha Dhonde
• Phone: 1-877-341-8309
• Email: TeamHealthEnSuite@iwk.nshealth.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2025
• Completion date: June 2027