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

NCT ID: NCT06203639

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2025-12-30

Brief Summary

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.

Detailed 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.

Conditions

Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

UR Caregiver group

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.

Group Type: EXPERIMENTAL

UR Caregiver

Intervention Type: OTHER

The UR Caregiver app was informed by previous research and developed in collaboration with caregiver partners. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. The app consists of seven modules. The app is available on IOS and Googe Play store. In addition to the didactic information provided in the app, worksheets are available in each module to practice the strategy/skill provided.

Active control

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

Group Type: ACTIVE_COMPARATOR

CLEAR Dementia Care

Intervention Type: OTHER

A subset of participants will be randomly assigned to use the CLEAR Dementia Care app as part of an active control group. The app consists of features that primarily address care-related needs (as opposed to stress management strategies) allowing for a comparison with the UR Caregiver app. The app was developed by the Northern Health and Social Care Trust (Northern Ireland) and is freely available on both IOS and Google Play stores. The CLEAR Dementia Care app provides users with information about dementia (e.g., the different types of dementia, how dementia affects the brain, and symptoms associated with dementia). The app offers suggestions and alternative approaches to various care-related situations through illustrations/images that caregivers may experience.

Non-app using control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

UR Caregiver

The UR Caregiver app was informed by previous research and developed in collaboration with caregiver partners. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. The app consists of seven modules. The app is available on IOS and Googe Play store. In addition to the didactic information provided in the app, worksheets are available in each module to practice the strategy/skill provided.

Intervention Type: OTHER

CLEAR Dementia Care

A subset of participants will be randomly assigned to use the CLEAR Dementia Care app as part of an active control group. The app consists of features that primarily address care-related needs (as opposed to stress management strategies) allowing for a comparison with the UR Caregiver app. The app was developed by the Northern Health and Social Care Trust (Northern Ireland) and is freely available on both IOS and Google Play stores. The CLEAR Dementia Care app provides users with information about dementia (e.g., the different types of dementia, how dementia affects the brain, and symptoms associated with dementia). The app offers suggestions and alternative approaches to various care-related situations through illustrations/images that caregivers may experience.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Hadjistavropoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

PMID: 6668417 (View on PubMed)

Graessel E, Berth H, Lichte T, Grau H. Subjective caregiver burden: validity of the 10-item short version of the Burden Scale for Family Caregivers BSFC-s. BMC Geriatr. 2014 Feb 20;14:23. doi: 10.1186/1471-2318-14-23.

Reference Type: BACKGROUND

PMID: 24555474 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16717171 (View on PubMed)

Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

Reference Type: BACKGROUND

PMID: 16250744 (View on PubMed)

Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.

Reference Type: BACKGROUND

PMID: 33146727 (View on PubMed)

Other Identifiers

2022-069

Identifier Type: -

Identifier Source: org_study_id