DementiaPhase 1/2NCT04587583
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
A Phase 1/2 study testing WeCareAdvisor in people with Dementia and Caregiver, run by University of Michigan at 1 site in United States.
Trial summary
This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Caregiver, Memory Disorders
- What is being tested?
- WeCareAdvisor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 21 Oct 2021
- Phase
- Phase 1/2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible caregivers must:
- Be the primary caregiver of a military veteran with dementia for at least 6 months and planning to remain the primary caregiver for the next 2 months
- Currently living with the person they are caring for (care recipient)
- Comfortable utilizing technology (e.g. computers, tablets, the internet)
- Have access to the internet and a computer or tablet device
- Plans to live in the area for the duration of the study
Show all 11Show fewer
- Care recipients (military veteran living with dementia) must:
- Exhibit at least one or more behavioral symptoms (any behavior at any frequency)
- Receiving psychotropic medication or cognitive enhancers will not exclude the care recipient.
- Have a clinical diagnosis of dementia (any type) per caregiver report.
- Be a military veteran.
Who cannot join
- Inability to read, speak or understand English
- Lack of regular access to a telephone, internet, technology (tablet or computer)
- Caregiver is unable to use a computer or tablet
- Person with dementia is not a military veteran
Trial locations and contacts
1 site in 1 country.
About this study
This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. 60 caregiver-person with dementia dyads will be recruited (30 Treatment Group, 30 Wait-List Control Group).
- Conditions
- Dementia, Caregiver, Memory Disorders, Alzheimer Disease, Behavioral Symptoms
- Being tested
- WeCareAdvisor
- Medical subject headings
- Dementia, Memory Disorders, Alzheimer Disease, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeCareAdvisorBehavioural
Tailored, internet-based software intended to assess, manage and track behavioral symptoms and their contributing factors and to instruct dementia caregivers in problem solving approaches (tailored strategies for in-home, medication-free behavior management) to address difficult or disruptive behaviors exhibited by the person with dementia. During the testing period participants will refer to the WeCareAdvisor when behavioral challenges occur.
| Study group | Role | What they receive |
|---|---|---|
| WeCareAdvisor | Active comparator | immediate use of the WeCareAdvisor tool for a 1 month period Receives: Behavioral: WeCareAdvisor |
| WeCareAdvisor after 1 month | Active comparator | after a wait period of 1 month, use of the WeCareAdvisor tool for a 1 month period Receives: Behavioral: WeCareAdvisor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Stress
As measured by a study specific questionnaire completed by caregivers. Stress is measured on a scale of 1 to 5 where 1 is equivalent to no stress and 5 is equivalent to extreme stress.
Measured: Baseline to 2 months
Change in Caregiver Confidence in Managing Problematic Behavior
As measured by a study specific questionnaire completed by caregivers. Confidence in managing problematic behavior is measured on a scale of 0 to 10, where a score of 0 means not confident and 10 means extremely confident
Measured: Baseline to 2 months
Change in Caregiver Upset
As measured by a study specific questionnaire completed by caregivers. Upset is measured on a scale of 0 to 5 where 0 is equivalent to no upset and 5 is equivalent to extreme upset (midpoint is equivalent to fairly upset).
Measured: Baseline to 2 months
Secondary outcomes (1)
Change in Caregiver Communication
Caregivers rate the frequency of using six forms of negative communication (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming), measured on a scale of 1 to 5 where a score of 1 is never and a score of 5 is always.
Measured: Baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Oct 2020
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
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 MichiganThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Frederic C. Blow, University of Michigan
- Investigators
- Frederic C Blow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587583
- Sponsor's protocol ID
- HUM00117707
- Other IDs
- W81XWH-16-1-0551
- Status last verified
- Mar 2022
- First submitted
- 7 Oct 2020
- Last updated
- 31 Mar 2022
- Results posted
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
- ClinicalTrials.gov ID
- NCT04587583
- Acronym / sponsor ID
- HUM00117707
- Conditions
- Dementia, Caregiver, Memory Disorders, Alzheimer Disease, Behavioral Symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 14 Oct 2020 (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.
This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. 60 caregiver-person with dementia dyads will be recruited (30 Treatment Group, 30 Wait-List Control Group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WeCareAdvisor | Active comparator | Behavioral: WeCareAdvisorimmediate use of the WeCareAdvisor tool for a 1 month period |
| WeCareAdvisor after 1 month | Active comparator | Behavioral: WeCareAdvisorafter a wait period of 1 month, use of the WeCareAdvisor tool for a 1 month period |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be the primary caregiver of a military veteran with dementia for at least 6 months and planning to remain the primary caregiver for the next 2 months
- Currently living with the person they are caring for (care recipient)
- Comfortable utilizing technology (e.g. computers, tablets, the internet)
- Have access to the internet and a computer or tablet device
- Plans to live in the area for the duration of the study
Key exclusion criteria (4 listed)
- Inability to read, speak or understand English
- Lack of regular access to a telephone, internet, technology (tablet or computer)
- Caregiver is unable to use a computer or tablet
- Person with dementia is not a military veteran
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 |
|---|---|---|
| WeCareAdvisorTailored, internet-based software intended to assess, manage and track behavioral symptoms and their contributing factors and to instruct dementia caregivers in problem solving approaches (tailored strategies for in-home, medication-free behavior management) to address difficult or disruptive behaviors exhibited by the person with dementia. During the testing period participants will refer to the WeCareAdvisor when behavioral challenges occur. | Behavioural | WeCareAdvisor, WeCareAdvisor after 1 month |
Primary outcome
Change in Caregiver Stress
Time frame: Baseline to 2 months
As measured by a study specific questionnaire completed by caregivers. Stress is measured on a scale of 1 to 5 where 1 is equivalent to no stress and 5 is equivalent to extreme stress.
Change in Caregiver Confidence in Managing Problematic Behavior
Time frame: Baseline to 2 months
As measured by a study specific questionnaire completed by caregivers. Confidence in managing problematic behavior is measured on a scale of 0 to 10, where a score of 0 means not confident and 10 means extremely confident
Change in Caregiver Upset
Time frame: Baseline to 2 months
As measured by a study specific questionnaire completed by caregivers. Upset is measured on a scale of 0 to 5 where 0 is equivalent to no upset and 5 is equivalent to extreme upset (midpoint is equivalent to fairly upset).
1 secondary outcome
Change in Caregiver Communication
Time frame: Baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Frederic C Blow, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WeCareAdvisor in people with Dementia and Caregiver, run by University of Michigan at 1 site 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 11 inclusion and 4 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 31 Mar 2022. 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Caregiver Stress (time frame: Baseline to 2 months). The study lists 3 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 31 Mar 2022.