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

An Information and Computer Technology-based Mobile Application for Training of Family Members Caring for Someone With Dementia

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.

Study Overview

• Status: Unknown
• Conditions: Dementia
• Intervention / Treatment: Device: Caring4Dementia; Other: White Paper

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Recruiting
      • Riverview Health Centre
      • Contact: M Klassen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: White Paper Group; The White Paper group will receive a white paper on the principles of communicating efficiently with persons living with dementia.	Other: 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.
No Intervention: Control Goup; The control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caregiver burden	Measured by the Short version of the Burden Scale for Family Caregivers. This is a 10-item instrument. Each item is a statement that is rated on a 4-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). The scale ranges from 0 to 30, with a higher dimension score indicating greater intensity in that dimension.	Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Change in caregivers' perceived challenges and resources	Measured by the Adult Carer Quality of Life Questionnaire, a 40-item instrument that measures the overall quality of life for adult carers, and subscale scores for eight domains of quality of life. Scores on the overall questionnaire have a possible range of 0 to 120 with higher scores indicating greater quality of life.	Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Activity volume on the Caring4Dementia app	Usage logs will be saved on the cloud to quantify the time (s) spent on every activity for all the activities.	30 days
Activity frequency on the Caring4Dementia app	Usage logs will be saved on the cloud to quantify the frequency of use of every activity in the application for all the activities (how many time per day the caregiver engage in the activity).	30 days

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: dementia; communication; mobile application; care-giving
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: HS23111 (H2019:319)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No