DementiaNCT04330482
Translating a Dementia Caregiver Intervention Into a Mobile Application
A study testing CARE-Well App and Internet Links in people with Dementia and Alzheimer Disease, run by Rhode Island Hospital at 2 sites in United States.
Trial summary
The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease, Caregiver Burnout
- What is being tested?
- CARE-Well App and Internet Links
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adequate English-speaking and reading skills
- Provide at least 4 hours of supervision per day for the care recipient (either directly or by telephone)
- Live in the community (either with the care recipient or without)
- Have provided supervision/ assistance for at least 6 months prior to study enrollment and have no plans to place care recipient in long term care or to end their role as caregiver within 6 months of study enrollment.
- Report some degree of distress associated with caregiving
- Access to Wifi at home
Who cannot join
- Major acute medical illness
- Severe mental illness (e.g. bipolar, schizophrenia)
- Diagnosed cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rhode Island
Kingston, Rhode Island, 02881
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.
Read the detailed description
Caring for a person with dementia is a highly stressful activity and is associated with negative physical and mental health consequences, including increased risk of depression and worse reported health-related quality of life. The proposed project aims to develop and translate an evidence-based, multi-component intervention into a mHealth App that has the potential to increase dementia caregivers' access to support and care.
The investigators will conduct a feasibility trial, in which 40 dementia caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App or preloaded with internet links relevant to dementia and caregiving. Paper outcome measures will be assessed at baseline and end of intervention (3 months) during each study visit. To measure sustainability of the App, the first 10 caregivers from each group will be offered the tablets for an additional month to monitor usage of the App outside the formal trial. The goal of this aim is to determine feasibility of the intervention, study procedures, and outcome measures.
- Conditions
- Dementia, Alzheimer Disease, Caregiver Burnout
- Being tested
- CARE-Well App, Internet Links
- Keywords
- MobileHealth, Caregiving, Dementia, Alzheimer Disease
- Medical subject headings
- Dementia, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE-Well AppBehavioural
Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
Internet LinksBehavioural
Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Internet Links | Other | A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months. Receives: Behavioral: Internet Links |
| CARE-Well App | Experimental | A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months. Receives: Behavioral: CARE-Well App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomization
Percentage of participants who decline participation because of randomization.
Measured: 3 months
Study Enrollment Rate and Retention
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Measured: 3 months
Intervention Adherence
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Measured: 3 months
Timing of Assessments
Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Measured: 3 months
Completion Rates
Percentage of participants who completed the intervention.
Measured: 3 months
Interest in Continuation of Tablet/App Use After Formal Trial
Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.
Measured: 3 months
App Technology Satisfaction
Percentage of participants satisfied or very satisfied with App technology.
Measured: 3 months
App Content Satisfaction
Percentage of participants satisfied or very satisfied with App content.
Measured: 3 months
Secondary outcomes (4)
Center for Epidemiologic Studies Depression Scale
Depression scale; 0-30 points; higher scores indicate worse outcome.
Measured: Baseline and immediately Post-Intervention at 3 months
Zarit Burden Interview
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Measured: Baseline and immediately Post-Intervention at 3 months
Revised Memory and Behavior Problem Checklist
Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.
Measured: Baseline and immediately Post-Intervention at 3 months
Desire to Institutionalize Scale
Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).
Measured: Baseline and immediately Post-Intervention at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start13 Jan 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- A full-scale randomized, controlled trial: 20 participants will be randomized to receive a tablet pre-loaded with a list of internet links relevant to dementia caregiving and 20 participants will be randomized to receive a tablet pre-loaded with the CARE-Well App. Both groups will be instructed to use their tablets at least 4 times per week for 3 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island
- Responsible party
- Principal investigator, Geoffrey Tremont, Rhode Island Hospital
- Investigators
- Geoffrey Tremont, PhD, Principal investigator, Rhode Island HospitalKunal Mankodiya, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330482
- Sponsor's protocol ID
- 1R21AG064410-01
- Status last verified
- Sep 2023
- First submitted
- 19 Mar 2020
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating a Dementia Caregiver Intervention Into a Mobile Application
- ClinicalTrials.gov ID
- NCT04330482
- Acronym / sponsor ID
- 1R21AG064410-01
- Conditions
- Dementia, Alzheimer Disease, Caregiver Burnout
- Keywords
- MobileHealth, Caregiving, Dementia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Rhode Island
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.
Detailed description
Caring for a person with dementia is a highly stressful activity and is associated with negative physical and mental health consequences, including increased risk of depression and worse reported health-related quality of life. The proposed project aims to develop and translate an evidence-based, multi-component intervention into a mHealth App that has the potential to increase dementia caregivers' access to support and care.
The investigators will conduct a feasibility trial, in which 40 dementia caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App or preloaded with internet links relevant to dementia and caregiving. Paper outcome measures will be assessed at baseline and end of intervention (3 months) during each study visit. To measure sustainability of the App, the first 10 caregivers from each group will be offered the tablets for an additional month to monitor usage of the App outside the formal trial. The goal of this aim is to determine feasibility of the intervention, study procedures, and outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A full-scale randomized, controlled trial: 20 participants will be randomized to receive a tablet pre-loaded with a list of internet links relevant to dementia caregiving and 20 participants will be randomized to receive a tablet pre-loaded with the CARE-Well App. Both groups will be instructed to use their tablets at least 4 times per week for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Internet Links | Other | Behavioral: Internet LinksA tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months. |
| CARE-Well App | Experimental | Behavioral: CARE-Well AppA tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adequate English-speaking and reading skills
- Provide at least 4 hours of supervision per day for the care recipient (either directly or by telephone)
- Live in the community (either with the care recipient or without)
- Have provided supervision/ assistance for at least 6 months prior to study enrollment and have no plans to place care recipient in long term care or to end their role as caregiver within 6 months of study enrollment.
- Report some degree of distress associated with caregiving
Key exclusion criteria (3 listed)
- Major acute medical illness
- Severe mental illness (e.g. bipolar, schizophrenia)
- Diagnosed cognitive impairment
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 |
|---|---|---|
| CARE-Well AppParticipants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week. | Behavioural | CARE-Well App |
| Internet LinksParticipants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week. | Behavioural | Internet Links |
Primary outcome
Randomization
Time frame: 3 months
Percentage of participants who decline participation because of randomization.
Study Enrollment Rate and Retention
Time frame: 3 months
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Intervention Adherence
Time frame: 3 months
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Timing of Assessments
Time frame: 3 months
Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Completion Rates
Time frame: 3 months
Percentage of participants who completed the intervention.
Interest in Continuation of Tablet/App Use After Formal Trial
Time frame: 3 months
Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.
App Technology Satisfaction
Time frame: 3 months
Percentage of participants satisfied or very satisfied with App technology.
App Content Satisfaction
Time frame: 3 months
Percentage of participants satisfied or very satisfied with App content.
4 secondary outcomes
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline and immediately Post-Intervention at 3 months
Zarit Burden Interview
Time frame: Baseline and immediately Post-Intervention at 3 months
Revised Memory and Behavior Problem Checklist
Time frame: Baseline and immediately Post-Intervention at 3 months
Desire to Institutionalize Scale
Time frame: Baseline and immediately Post-Intervention at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Geoffrey Tremont, PhD principal investigator
Rhode Island Hospital
Kunal Mankodiya, PhD principal investigator
University of Rhode Island
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE-Well App and Internet Links in people with Dementia and Alzheimer Disease, run by Rhode Island Hospital at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Randomization (time frame: 3 months). The study lists 8 primary outcomes in all. 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 28 Sep 2023.