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

NCT04139707 | Unknown

• 1 other identifier: HS23111 (H2019:319)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

dementia; care-giving; communication; mobile application

Outcome Measures

Primary Outcomes (1)

• Change in caregiver well-being

  Measured by the Caregiver Well-Being Scale to determine the frequency in which basic needs and activities of living have been met for the caregiver within the last three months. Items in this self-reported scale are scored on a 5-point scale \[ranging form "Rarely (1)" to "Usually (5)"\], with a higher dimension score indicating greater intensity in that dimension. The highest score possible is 70, meaning a higher well-being.

  Baseline (Day 1), post (day 30), Retention (90 days) after baseline

Secondary Outcomes (4)

• Change in caregiver burden

  Baseline (Day 1), post (day 30), Retention (90 days) after baseline

• Change in caregivers' perceived challenges and resources

  Baseline (Day 1), post (day 30), Retention (90 days) after baseline

• Activity volume on the Caring4Dementia app

  30 days

• Activity frequency on the Caring4Dementia app

  30 days

Study Arms (3)

Caring4Dementia Group

EXPERIMENTAL

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.

Device: Caring4Dementia

White Paper Group

ACTIVE COMPARATOR

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

Other: White Paper

Control Goup

NO INTERVENTION

The control group will not receive any intervention.

Interventions

Caring4Dementia 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.

Caring4Dementia Group

White Paper 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.

White Paper Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or over
• Give written and oral informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Centre

Winnipeg, Manitoba, Canada

RECRUITING

MeSH Terms

Conditions

Dementia; Communication

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Amine Choukou, PhD

CONTACT

+12047893412; amine.choukou@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: January 2, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)