DementiaNCT02420535
An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
A study testing Immediately Receive Tool and One Month Delay in people with Dementia, run by University of Michigan at 2 sites in United States.
Trial summary
Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Immediately Receive Tool and One Month Delay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Oct 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General
- Age 21 years or older
- Ability to read, speak and understand English
- Home location within 50 miles of the study site Caregivers (CG)
- Active primary caregiver of a Person with Dementia (PwD) for at least 6 months and planning to remain the primary caregiver for the next 2 months
- Currently living with the PwD
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- CG plans to live in the area for the duration of the study
- Is familiar and comfortable utilizing technology (e.g. computers, tablets, the internet)
- Persons with Dementia (PwD)
- CG reports that the PwD exhibits at least one or more behavioral symptoms (any behavior at any frequency)
- PwD receiving psychotropic medication or cognitive enhancers will not be excluded.
- If PwD is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that he/she have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.
- Clinical diagnosis of dementia (any type) or a score of less than 24 on the Mini-Mental State Examination (MMSE)
Who cannot join
- General
- Inability to read, speak or understand English
- Home location greater than 50 miles from the study site
- Lack of regular access to a telephone Caregivers (CG)
- Reading literacy of less than 6th grade
- Visual impairment to the extent of prohibiting interaction with the tool
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- Hearing impairment sufficient to prohibit telephone communication
- Other self-identified mental or physical health issues that would distinctly interfere with the ability to reasonably test the tool or complete behavioral interventions (e.g. substance use disorder, schizophrenia, severe mobility issues)
- Hospitalized more than 3 times in the past year
- Participating in another study to help caregivers care for the person with dementia.
- Persons with Dementia (PwD)
- At a terminal phase of illness, unable to respond to the environment or with a life expectancy less than 6 months
- Active suicide risk
- Imminent placement to nursing home (within the next 60 days)
- Hospitalized more than 3 times in the past year
- Currently in another study testing a medication to control behavioral symptoms
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Department of Psychiatry
Ann Arbor, Michigan, 48109
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors. The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to 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. This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.
- Conditions
- Dementia
- Being tested
- Immediately Receive Tool, One Month Delay
- Keywords
- Dementia, Alzheimer's Disease, Caregivers, Behavioral, Caregiver burden
- Medical subject headings
- Dementia, Alzheimer Disease, Behavior, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediately Receive ToolBehavioural
One Month DelayBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Immediately Receive Tool | Experimental | Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks. Receives: Behavioral: Immediately Receive Tool |
| One Month Delay | Active comparator | Caregiver/Care Recipient Dyad will be randomly assigned to a 4 week delay (usual care activities only) before receiving the WeCareAdvisor Tool for 4 weeks. Receives: Behavioral: One Month Delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the WeCareAdvisor Tool on Caregiver Upset
We will measure caregiver upset on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
Measured: 4 weeks
Effect of the WeCareAdvisor Tool on Caregiver Confidence
We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Helen Kales, University of Michigan
- Investigators
- Helen Kales, MD, Principal investigator, University of MichiganLaura Gitlin, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420535
- Sponsor's protocol ID
- HUM00066639
- Status last verified
- Dec 2016
- First submitted
- 14 Apr 2015
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
PubMed 33417236Kales HC, Gitlin LN, Stanislawski B, Myra Kim H, Marx K, Turnwald M, Chiang C, Lyketsos CG. Effect of the WeCareAdvisor on family caregiver outcomes in dementia: a pilot randomized controlled trial. BMC Geriatr. 2018 May 10;18(1):113. doi: 10.1186/s12877-018-0801-8.
PubMed 29747583Gitlin LN, Kales HC, Marx K, Stanislawski B, Lyketsos C. A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor. Contemp Clin Trials. 2017 Nov;62:27-36. doi: 10.1016/j.cct.2017.08.001. Epub 2017 Aug 9.
PubMed 28800895
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
- ClinicalTrials.gov ID
- NCT02420535
- Acronym / sponsor ID
- HUM00066639
- Conditions
- Dementia
- Keywords
- Dementia, Alzheimer's Disease, Caregivers, Behavioral, Caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Apr 2015 (estimated)
- 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.
Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors. The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to 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. This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediately Receive Tool | Experimental | Behavioral: Immediately Receive ToolCaregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks. |
| One Month Delay | Active comparator | Behavioral: One Month DelayCaregiver/Care Recipient Dyad will be randomly assigned to a 4 week delay (usual care activities only) before receiving the WeCareAdvisor Tool for 4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- General
- Age 21 years or older
- Ability to read, speak and understand English
- Home location within 50 miles of the study site Caregivers (CG)
- Active primary caregiver of a Person with Dementia (PwD) for at least 6 months and planning to remain the primary caregiver for the next 2 months
Key exclusion criteria (16 listed)
- General
- Inability to read, speak or understand English
- Home location greater than 50 miles from the study site
- Lack of regular access to a telephone Caregivers (CG)
- Reading literacy of less than 6th grade
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 |
|---|---|---|
| Immediately Receive Tool | Behavioural | Immediately Receive Tool |
| One Month Delay | Behavioural | One Month Delay |
Primary outcome
Effects of the WeCareAdvisor Tool on Caregiver Upset
Time frame: 4 weeks
We will measure caregiver upset on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
Effect of the WeCareAdvisor Tool on Caregiver Confidence
Time frame: 4 weeks
We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
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 19 Dec 2016.
- Derived from this study: PubMed 33417236Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
- Derived from this study: PubMed 29747583Kales HC, Gitlin LN, Stanislawski B, Myra Kim H, Marx K, Turnwald M, Chiang C, Lyketsos CG. Effect of the WeCareAdvisor on family caregiver outcomes in dementia: a pilot randomized controlled trial. BMC Geriatr. 2018 May 10;18(1):113. doi: 10.1186/s12877-018-0801-8.
- Derived from this study: PubMed 28800895Gitlin LN, Kales HC, Marx K, Stanislawski B, Lyketsos C. A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor. Contemp Clin Trials. 2017 Nov;62:27-36. doi: 10.1016/j.cct.2017.08.001. Epub 2017 Aug 9.
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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.
Helen Kales, MD principal investigator
University of Michigan
Laura Gitlin, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediately Receive Tool and One Month Delay in people with Dementia, run by University of Michigan 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 13 inclusion and 16 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 19 Dec 2016. 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?
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?
Effects of the WeCareAdvisor Tool on Caregiver Upset (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420535, which also lists 3 linked publications.
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 19 Dec 2016.