Evaluation of an App to Alleviate Stress Among Caregivers of People With Dementia

University of Regina

Status: Active, not recruiting

Conditions: Caregiver Burden

Treatments: Other: UR Caregiver; Other: CLEAR Dementia Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06203639

2022-069

Details and patient eligibility

About

Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. The goal of our study is to test a newly developed app that focuses on providing stress management strategies for caregivers of people living with dementia.

Full description

Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. Psychological interventions that focus on building skills and providing strategies to improve their well-being have been shown to improve caregiver well-being. Although mobile applications (apps) are available for caregivers of people living with dementia, existing apps do not adequately address the stress and mental health needs experienced by caregivers of people living with dementia. In addition, there is a paucity of mobile app interventions that provide practical stress management strategies for caregivers. The goal of the study is to conduct an evaluation of a novel app (UR Caregiver) that focuses on providing stress management strategies for caregivers of people living with dementia. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. Caregivers of people living with dementia will be recruited and randomly assigned to three groups: 1) UR Caregiver; 2) active control; and 3) non-app using control. Participants in the app-using groups will be asked to use the app over an 8-week period. Stress, burden, and mental health will be assessed before, after the 8-week period, and at a follow-up period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Given the demands that caregivers of people living with dementia face daily, the creation and evaluation of an app that aims to provide stress-management strategies has the potential of improving the quality of life of caregivers of people living with dementia.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. caregivers providing informal and unpaid care (e.g., spouses, children, relatives) for a person living with dementia
2. providing primary care (i.e., most of the care or equally shares the care with another individual such as a mother or sibling) for the person living with dementia
3. own a smartphone/tablet (i.e., can access either IOS or Android platforms).

Exclusion criteria

1. Currently using an app for caregiver stress/burden

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

UR Caregiver group

Experimental group

Description:

Participants will be asked to use the UR Caregiver app daily (e.g., at least 15 minutes/day) for 8 weeks and complete and practice one module per week. On the eighth week, participants will be asked to review one of the past modules of their choice.

Treatment:

Other: UR Caregiver

Active control

Active Comparator group

Description:

Participants will be asked to use the app daily (e.g., at least 15 minutes/day) for an 8-week period.

Treatment:

Other: CLEAR Dementia Care

Non-app using control

No Intervention group

Description:

Participants in this group will not be using any apps in the study.