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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139707
• Other study ID #: HS23111 (H2019:319)
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2020
• Source: University of Manitoba
• Contact: Amine Choukou, PhD
• Phone: +12047893412
• Email: amine.choukou[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	Riverview Health Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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