A Mobile Application for Training of Family Caregivers Caring for Someone With Dementia

NCT ID: NCT04139707

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2020-07-31

Brief Summary

Background

The mental, physical, and emotional health of caregivers is negatively affected by the burden of caring for of persons living with dementia. Caregivers are usually reported as feeling frustrated, angry, exhausted, guilty, helpless and unable to bear the heavy burden of their caregiving responsibilities. In addition to depressive symptoms and other mental health problems among caregivers, the physical stress of caring for someone who is unable to perform daily activities such as bathing, grooming and other personal care, has been shown to be a serious threat to caregivers' physical health outcomes. Evidence has shown that greater levels of stress, anxiety, depression, frustration, and lower subjective well-being and self-efficacy are exhibited in a greater amount among family and friends who care for persons living with dementia compared to those who do not have the burden of caring for a persons living with dementia. Caregivers have been shown to use alcohol and other drugs at a higher rate than those who do not need to care for others as a reaction to this increased stress. Studies has also shown that caregivers are more likely than non-Caregivers to use opioid or psychotropic medications. One over five caregivers (22%) feel tired when they go to bed at night.

Objectives

This study relies on a mobile application (Caring4Dementia) that provides people, caring for a person living with dementia, with a useful and intuitive training tool targeting communication skills. The aims of this study are to evaluate the feasibility and acceptability of using Caring4Dementia within a self-administered program and the preliminary efficacy of the Caring4Dementia intervention.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Caring4Dementia Group

The experimental group will receive Careing4Dementia downloadable on their smartphone or tablet. Caring4Dementia will tell and show caregivers of a person living with dementia how to 1) manage difficult behaviors, 2) deal with refusal, 3) deal with tensions and 4) manage work-life demands. The app is self-administered and self-paced and contains surveys referring to the outcome measurements tools used in the study. The intervention will be for 30 days without any restriction or limitation in terms of timing, location or frequency of use.

Group Type: EXPERIMENTAL

Caring4Dementia

Intervention Type: DEVICE

A mobile application administered for 30 days, which provides people caring for a person living with dementia with a useful and intuitive tool targeting communication skills.

White Paper Group

The White Paper group will receive a white paper on the principles of communicating efficiently with persons living with dementia.

Group Type: ACTIVE_COMPARATOR

White Paper

Intervention Type: OTHER

The White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia.

Control Goup

The control group will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caring4Dementia

A mobile application administered for 30 days, which provides people caring for a person living with dementia with a useful and intuitive tool targeting communication skills.

Intervention Type: DEVICE

White Paper

The White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informal caregiver of a person living with dementia for more than 6 months
• Able to read and understand English
• Able to use smartphones and tablets (Apple or Android)
• Have a smartphone or tablet (Apple or Android) with internet connection, involved in this study
• 18 years or over
• Give written and oral informed consent

Exclusion Criteria

• None

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

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Amine Choukou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Riverview Health Centre

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Amine Choukou, PhD

Role: CONTACT

amine.choukou@umanitoba.ca

+12047893412

Facility Contacts

M Klassen

Role: primary

Other Identifiers

HS23111 (H2019:319)

Identifier Type: -

Identifier Source: org_study_id