An interventional study of Caring4Dementia and White Paper in Dementia, sponsored by University of Manitoba. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 120 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The White Paper group will receive a white paper on the principles of communicating efficiently with persons living with dementia.
Other: White Paper
The control group will not receive any intervention.
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.
The White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia.
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.
Time frame: Baseline (Day 1), post (day 30), Retention (90 days) after baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Manitoba