DementiaNCT04139707
A Mobile Application for Training of Family Caregivers Caring for Someone With Dementia
A study testing Caring4Dementia and White Paper in people with Dementia, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Caring4Dementia and White Paper
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Riverview Health Centre
Winnipeg, Manitoba
M Klassen
About this study
Official title: 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.
Read more
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
- Being tested
- Caring4Dementia, White Paper
- Keywords
- dementia, care-giving, communication, mobile application
- Medical subject headings
- Dementia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring4DementiaDevice
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.
White PaperOther
The White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: White Paper |
| Control Goup | No intervention | The control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start2 Jan 2020
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amine Choukou, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139707
- Sponsor's protocol ID
- HS23111 (H2019:319)
- Status last verified
- Mar 2020
- First submitted
- 21 Oct 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Information and Computer Technology-based Mobile Application for Training of Family Members Caring for Someone With Dementia
- ClinicalTrials.gov ID
- NCT04139707
- Acronym / sponsor ID
- HS23111 (H2019:319)
- Conditions
- Dementia
- Keywords
- dementia, care-giving, communication, mobile application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Pilot Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Caring4Dementia Group | Experimental | Device: Caring4DementiaThe 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. |
| White Paper Group | Active comparator | Other: White PaperThe White Paper group will receive a white paper on the principles of communicating efficiently with persons living with dementia. |
| Control Goup | No intervention | –The control group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caring4DementiaA 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. | Device | Caring4Dementia Group |
| White PaperThe White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia. | Other | White Paper Group |
Primary outcome
Change in caregiver well-being
Time frame: Baseline (Day 1), post (day 30), Retention (90 days) after baseline
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.
4 secondary outcomes
Change in caregiver burden
Time frame: Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Change in caregivers' perceived challenges and resources
Time frame: Baseline (Day 1), post (day 30), Retention (90 days) after baseline
Activity volume on the Caring4Dementia app
Time frame: 30 days
Activity frequency on the Caring4Dementia app
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring4Dementia and White Paper in people with Dementia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amine Choukou, PhD (+12047893412, amine.choukou@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver well-being (time frame: Baseline (Day 1), post (day 30), Retention (90 days) after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.