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

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Caring4Dementia
White Paper
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring dementia, care-giving, communication, mobile application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Riverview Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Caring4Dementia Group

White Paper Group

Control Goup

Arm Description

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.

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

The control group will not receive any intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
October 21, 2019
Last Updated
March 23, 2020
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04139707
Brief Title
A Mobile Application for Training of Family Caregivers Caring for Someone With Dementia
Official Title
An Information and Computer Technology-based Mobile Application for Training of Family Members Caring for Someone With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, care-giving, communication, mobile application

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomized Controlled Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caring4Dementia Group
Arm Type
Experimental
Arm Description
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.
Arm Title
White Paper Group
Arm Type
Active Comparator
Arm Description
The White Paper group will receive a white paper on the principles of communicating efficiently with persons living with dementia.
Arm Title
Control Goup
Arm Type
No Intervention
Arm Description
The control group will not receive any intervention.
Intervention Type
Device
Intervention Name(s)
Caring4Dementia
Intervention Description
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
Other
Intervention Name(s)
White Paper
Intervention Description
The White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia.
Primary Outcome Measure Information:
Title
Change in caregiver well-being
Description
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.
Time Frame
Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Secondary Outcome Measure Information:
Title
Change in caregiver burden
Description
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.
Time Frame
Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Title
Change in caregivers' perceived challenges and resources
Description
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.
Time Frame
Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Title
Activity volume on the Caring4Dementia app
Description
Usage logs will be saved on the cloud to quantify the time (s) spent on every activity for all the activities.
Time Frame
30 days
Title
Activity frequency on the Caring4Dementia app
Description
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).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amine Choukou, PhD
Phone
+12047893412
Email
amine.choukou@umanitoba.ca
Facility Information:
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Klassen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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