App for Caregiver Stress in Dementia

Overseen By Louise Castillo, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Using caregiver stress app

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to help caregivers of people with dementia manage stress. Caregiving can be challenging, and the app offers strategies to ease mental health burdens. The study includes three groups: one using the CLEAR Dementia Care app with specific modules, one using the app generally, and one not using the app. Unpaid caregivers for someone with dementia who have a smartphone or tablet may be a good fit. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for caregiver support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this app is safe for caregivers of people living with dementia?

Research shows that the UR Caregiver app is designed to help reduce stress for caregivers of people with dementia. Previous studies have found that similar support tools can decrease stress, depression, and loneliness. This suggests the app is likely safe, as it emphasizes stress management strategies rather than medication. No reports of negative effects have emerged from using the app. The study is labeled "Not Applicable" in terms of phases, indicating that the treatment is not expected to pose major safety concerns. This label is often used for non-invasive interventions, like an app, that do not involve testing new drugs or therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative app-based approaches to managing caregiver stress in dementia care. Unlike traditional methods that may involve in-person support or group therapy, the UR Caregiver app offers a flexible, daily intervention that caregivers can access at their convenience, potentially reducing stress more effectively. This trial also tests the CLEAR Dementia Care app, which aims to provide structured support and practice modules that can be revisited, offering personalized and continuous help. By leveraging technology, these apps provide new ways to support caregivers, potentially improving their well-being and care outcomes for those with dementia.

What evidence suggests that this trial's apps could be effective for managing caregiver stress in dementia?

Earlier research has shown that using the internet or mobile apps effectively reduces stress for family members caring for older adults with dementia. One study found that people who joined an online caregiver support group for eight weeks felt less stressed, depressed, and lonely. Additionally, caregivers who used a specially designed mobile app reported reduced stress. In this trial, participants in the UR Caregiver group will use the UR Caregiver app, which may help manage stress for those caring for people with dementia. ^{1 3 4 6 7}

Who Is on the Research Team?

Thomas Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for unpaid caregivers, like family members, who are the primary carers for someone with dementia. They must own a smartphone or tablet but cannot already be using an app to manage caregiver stress.

Inclusion Criteria

Caregivers providing informal and unpaid care (e.g., spouses, children, relatives) for a person living with dementia

I am the main or one of the main caregivers for someone with dementia.

Own a smartphone/tablet (i.e., can access either IOS or Android platforms)

Exclusion Criteria

I am using an app to help manage my caregiver stress.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the UR Caregiver app daily for 8 weeks, completing one module per week

8 weeks

Daily app usage

Follow-up

Participants are monitored for changes in stress, burden, and mental health after the treatment period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CLEAR Dementia Care
• UR Caregiver

Trial Overview The study tests a new app designed to help caregivers of people with dementia manage their stress. It will evaluate how effective the app is in providing strategies to alleviate the mental burden of caregiving.

How Is the Trial Designed?

Group I: UR Caregiver group Experimental Treatment 1 Intervention

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 II: Active control Active Control 1 Intervention

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

Group III: Non-app using control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Published Research Related to This Trial

The feasibility study of an 8-week virtual caregiver support group using avatars showed significant reductions in perceived stress, depression, and loneliness among participants, indicating its effectiveness in providing emotional support.

Participants reported high satisfaction and a strong sense of group presence, suggesting that the virtual format successfully overcame barriers to participation typically faced by caregivers of individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtually supportive: a feasibility pilot study of an online support group for dementia caregivers in a 3D virtual environment. O'Connor, MF., Arizmendi, BJ., Kaszniak, AW.[2022]

The FindMyApps tablet intervention was found to be useful and easy to use for individuals with mild dementia, helping them discover and engage with apps for self-management and meaningful activities, although they often required support from their informal carers.

While no significant differences were observed in outcome measures, qualitative feedback suggests that FindMyApps has the potential to enhance self-management abilities and engagement in activities for people with dementia, warranting further evaluation in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled feasibility study of FindMyApps: first evaluation of a tablet-based intervention to promote self-management and meaningful activities in people with mild dementia. Kerkhof, Y., Kohl, G., Veijer, M., et al.[2022]

A study of 117 dementia caregivers found that perceived usefulness of mHealth apps was the strongest predictor of their intention to adopt these tools for managing chronic conditions, with an odds ratio of 23, indicating a significant relationship.

Caregiving factors like caregiver burden and time spent caregiving did not significantly influence the intention to adopt mHealth apps, suggesting that focusing on app features that enhance perceived usefulness may be more effective in encouraging adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Intention to Adopt mHealth Apps Among Dementia Caregivers With a Chronic Condition: Cross-sectional, Correlational Study. Mendez, KJW., Budhathoki, C., Labrique, AB., et al.[2021]

A mobile smartphone support app designed for primary caregivers of persons with dementia was found to be feasible and generally accepted, with participants reporting increased emotional well-being after a 12-week mindfulness-based self-compassion program.

While there were no significant changes in caregiver burden, the program successfully decreased emotion-based coping strategies, indicating a positive shift in how caregivers manage their stress and emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An App-Based Mindfulness-Based Self-compassion Program to Support Caregivers of People With Dementia: Participatory Feasibility Study. Goodridge, D., Reis, N., Neiser, J., et al.[2022]

The 'Partner in Balance' (PiB) program, which combines face-to-face coaching with online modules, was well-received by both caregivers and coaches, with a participation rate of 51.9% among eligible caregivers, indicating its potential effectiveness in supporting early-stage dementia caregivers.

Despite overall satisfaction, challenges such as recruitment barriers and the need for tailored content for specific subgroups, like younger caregivers, were identified, suggesting that further adaptation and awareness of blended care programs are necessary for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial. Boots, LM., de Vugt, ME., Smeets, CM., et al.[2022]

Caregivers who reported feeling 'completely overwhelmed' at the start of a comprehensive dementia care program experienced significantly higher levels of distress, depression, and burden compared to those who did not feel overwhelmed, indicating a need for targeted support.

Despite the high levels of distress among overwhelmed caregivers, their feelings did not predict long-term outcomes such as nursing home placement or mortality for the patients they care for, suggesting that caregiver support may be crucial without directly impacting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overwhelmed: a Dementia Caregiver Vital Sign. Reuben, DB., Romero, T., Evertson, LC., et al.[2023]

A review of 16 apps for informal caregivers of people living with dementia revealed that their features may not adequately meet the diverse needs of these caregivers.

In a controlled trial comparing two of the apps to a control group, no significant differences were found in outcomes, highlighting the need for improved app design based on caregiver feedback for future developments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are mobile apps meeting the needs of caregivers of people living with dementia? An evaluation of existing apps for caregivers. Castillo, LIR., Tran, V., Hadjistavropoulos, T.[2023]

A review of 75 dementia-related apps revealed that while most are free and aimed at caregivers, they often lack comprehensive content and support, with limited language options beyond English.

The quality of these apps is generally low, as indicated by the MARS appraisal, highlighting a need for better standardization and support services to help users find effective resources for dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile apps for dementia awareness, support, and prevention - review and evaluation. Chelberg, GR., Neuhaus, M., Mothershaw, A., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06203639/evaluation-of-an-app-to-alleviate-stress-among-caregivers-of-people-with-dementia

Evaluation of an App to Alleviate Stress Among 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11311318/

Effectiveness of Internet-Based or Mobile App Interventions ... This study evaluated the effectiveness of internet-based or mobile app interventions for family caregivers of older adults with dementia.

3. withpower.com withpower.com/trial/phase-caregiver-burden-2024-be09c

App for Caregiver Stress in Dementia · Info for Participants The feasibility study of an 8-week virtual caregiver support group using avatars showed significant reductions in perceived stress, depression, and loneliness ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12483335/

Professional Support Through a Tailor-Made Mobile App to ... FCs with decreased caregiver stress scores after the intervention generally had a higher number of chat message entries (mean 6.5) directed ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03850613

Alleviating Caregivers' Stress Through an E-painting ... This study aims to develop a mobile app for caregivers and tests its feasibility for a period of 8 weeks. A mixed-method study design with both qualitative ...

6. play.google.com play.google.com/store/apps/details?id=ca.uregina.caregiver&hl=en_US

URCaregiver - Apps on Google Play The goal of the app is to share practical information and strategies to help manage the stress that caregivers might be experiencing. The app ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10603562/

Researched Apps Used in Dementia Care for People Living ... This review seeks to understand the landscape of existing mobile apps in dementia care for people living with dementia and their caregivers.