DementiaNCT05012410
WeCareAdvisor Study for Caregivers of People Living With Dementia
A study testing Immediate treatment group with High-Intensity Prompts and Immediate treatment group with Low-Intensity Prompts in people with Dementia and Caregiver Burnout, run by Drexel University at 1 site in United States.
Trial summary
The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia. The trial will evaluate its efficacy to reduce caregiver distress, improve confidence managing behaviors, as well as reduce occurrences and severity of behavioral and psychological… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregiver Burnout, Caregiver Stress Syndrome
- What is being tested?
- Immediate treatment group with High-Intensity Prompts and Immediate treatment group with Low-Intensity Prompts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 19 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as the primary caregiver to the person living with memory loss or dementia;
- has been a primary caregiver for at least 6 months;
- report managing >1 behavioral symptom(s) in the past month;
- has an email account or smartphone (to receive daily tips and reminder messages);
- English speaking;
- has own smartphone, tablet, laptop, or desktop computer and access to Internet;
Show all 9Show fewer
- If person living with dementia is on an anti-dementia or psychotropic medication, they must be on a stable dose for at least 60 days prior to enrollment.
- If caregiver is on an anti-depression or other psychotropic medication, they must be on a stable does for at least 60 days prior to enrollment
- Lives in the United States or US territory
Who cannot join
- Caregiver currently involved in another clinical trial of psychosocial or educational interventions for dementia;
- Caregiver has a visual impairment that prohibits interaction with the tool, and/or have a hearing impairment sufficient to prohibit telephone communication;
- Caregiver reports person living with dementia is not responsive to his/her environment (e.g., unable to understand short commands or recognize a person coming in/out of the room);
- Caregiver reports person living with dementia is an active suicide risk
- Caregiver reports person living with dementia is likely to have an imminent placement in a long-term care facility (within 6 months).
- Either caregiver/person living with dementia has a terminal disease with life expectancy < 6 months, is in active treatment for cancer, or has had more than 3 acute medical hospitalizations over the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons Living With Dementia
The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia. The trial will evaluate its efficacy to reduce caregiver distress, improve confidence managing behaviors, as well as reduce occurrences and severity of behavioral and psychological symptoms.
Visit https://wecareadvisorstudy.com/ for more information.
Read the detailed description
Caregivers enrolled in the study will use the web-based WeCareAdvisor tool for either three or six months, depending upon group allocation (immediate treatment vs. 3-month waitlist). Caregivers will be interviewed at baseline, 1, 3 and 6 months by telephone to evaluate their health and wellbeing. Also, utilization data of the tool will be captured.
- Conditions
- Dementia, Caregiver Burnout, Caregiver Stress Syndrome, Alzheimer Disease, Frontotemporal Dementia, Vascular Dementia
- Being tested
- Immediate treatment group with High-Intensity Prompts, Immediate treatment group with Low-Intensity Prompts, Waitlist Control after three months with High-Intensity Prompts, Waitlist Control after three months with Low-Intensity Prompts
- Keywords
- dementia, caregiver, alzheimer's disease, memory loss
- Medical subject headings
- Dementia, Caregiver Burden, Alzheimer Disease, Frontotemporal Dementia, Dementia, Vascular, Lewy Body Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate treatment group with High-Intensity PromptsBehavioural
Caregivers in the immediate treatment group with high-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive telephone and email prompts to use the tool.
Immediate treatment group with Low-Intensity PromptsBehavioural
Caregivers in the immediate treatment group with low-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive email prompts to use the tool.
Waitlist Control after three months with High-Intensity PromptsBehavioural
After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive telephone and email prompts. Once the caregiver receives the WeCareAdvisor tool, they will receive a weekly automated email as well as a weekly telephone call from study staff to prompt them to use the tool.
Waitlist Control after three months with Low-Intensity PromptsBehavioural
After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive email prompts.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment group with High-Intensity Prompts | Experimental | Caregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts. Receives: Behavioral: Immediate treatment group with High-Intensity Prompts |
| Immediate treatment group with Low-Intensity Prompts | Experimental | Caregivers will use the WeCareAdvisor tool for six months and receive email prompts only. Receives: Behavioral: Immediate treatment group with Low-Intensity Prompts |
| Waitlist Control after three months with high-Intensity prompts | Experimental | After three months, caregivers will receive WeCareAdvisor and telephone and email prompts. Receives: Behavioral: Waitlist Control after three months with High-Intensity Prompts |
| Waitlist Control after three months with Low-Intensity Prompts | Experimental | After three months, caregivers will receive WeCareAdvisor and email prompts only. Receives: Behavioral: Waitlist Control after three months with Low-Intensity Prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Change in Caregiver Distress with Behaviors
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Measured: 1 Month
Long-term Change in Caregiver Distress with Behaviors (3-Months)
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Measured: 3 months
Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 = low confidence - 10= high confidence)
Measured: 1 month
Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 (low-confidence - 10- high-confidence))
Measured: 3 months
Short-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
Neuropsychiatric Inventory-Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
Measured: 1 Month
Long-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
Measured: 3 Months
Secondary outcomes (16)
Short-Term Change in Person with Dementia- Level of Functioning
Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring # of ADLs/ IADLs needing assistance, and dependence level (1=total dependence to 7=total independence)
Measured: 1 months
Long-Term Change in Person with Dementia- Level of Functioning
Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring # of ADLs/ IADLs needing assistance, and dependence level (1=total dependence to 7=total independence)
Measured: 3 months
Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia
Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely)
Measured: 1 months
Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia
Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely)
Measured: 3 months
Change in Person with Dementia's Medications
Caregivers are asked to retrieve (e.g., Brown bag review) prescription and non-prescription medications of person living with dementia and relay name, frequency, and dosage for each medication to interviewer. The investigators will track information on changes in psychotropic medication use for persons living with dementia (intensifications, reductions, additions/deletions, or 'prn' or as needed use).
Measured: 6 months
Short Term Change in Caregiver Wellbeing
The investigators will use the 13-item Perceived Change for Better Index which assesses caregiver perceived change (1= gotten worse to 5= improved a lot) in affective wellbeing, somatic, ability to manage daily care. It is sensitive to change and has strong psychometric properties.
Measured: 1 Month
Long Term Change in Caregiver Wellbeing
The investigators will use the 13-item Perceived Change for Better Index which assesses caregiver perceived change (0=gotten worse to 5=improved a lot) in affective wellbeing, somatic, ability to manage daily care. It is sensitive to change and has strong psychometric properties.
Measured: 3 Months
Short Term Change in Caregiver- Negative Communications
The investigators will use six items from various scales that assess frequency of use (1=Never to 5=Always) of negative communications by caregivers with persons with dementia (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming).
Measured: 1 Month
Long Term Change in Caregiver- Negative Communications
The investigators will use six items from various scales that assess frequency of use (1=Never to 5=Always) of negative communications by caregivers with persons with dementia (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming).
Measured: 3 Month
Utilization of tool use
Dashboard data indicating number of times using tool, number of times using each section of the tool, amount of time spent and for each section of the tool, number of DICE sessions started and completed.
Measured: Through study completion, up to 6 months.
Short-Term Change in Person Living with Dementia- Frequency of Behaviors
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms.
Measured: 1 months
Long-Term Change in Person Living with Dementia- Frequency of Behaviors
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms.
Measured: 3 months
Short-Term Change in Person Living with Dementia- Severity of Behaviors
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms.
Measured: 1 months
Long-Term Change in Person Living with Dementia- Severity of Behaviors
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms.
Measured: 3 months
Short-Term Change in Person Living with Dementia- Number of Behaviors
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no).
Measured: 1 months
Long-Term Change in Person Living with Dementia- Number of Behaviors
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start13 Dec 2021
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Factorial
- Model description
- Prospective randomized trial involving an immediate treatment group (Group A) and a 3-month waitlist control group (Group B). Also, groups will be randomized to different prompting conditions (email only, telephone and email) to remind participants to use the tool.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, National Institute on Aging (NIA), Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Laura N Gitlin, PhD, Principal investigator, Drexel UniversityHelen C Kales, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012410
- Sponsor's protocol ID
- 2007007999
- Other IDs
- 1R01AG061116-01
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be stored after 7 years following completion of study and reporting of main outcomes.
Publications
Gitlin LN, Bouranis N, Kern V, Koeuth S, Marx KA, McClure LA, Lyketsos CG, Kales HC. WeCareAdvisor, an Online Platform to Help Family Caregivers Manage Dementia-Related Behavioral Symptoms: an Efficacy Trial in the Time of COVID-19. J Technol Behav Sci. 2022;7(1):33-44. doi: 10.1007/s41347-021-00204-8. Epub 2021 Mar 25.
PubMed 33786370Gitlin 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 28800895Kales 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, McClure LA, Webster MJ, Lyketsos C, Kales HC. Timing Matters: Effects of Delayed versus Immediate Access to a Web-Based Application on Caregiver Outcomes: The WeCareAdvisor Trial. Gerontologist. 2026 Sep 21:gnag226. doi: 10.1093/geront/gnag226. Online ahead of print.
PubMed 42767991Gitlin LN, McClure LA, Webster MJ, Lyketsos C, Kales HC. Effects of the WeCareAdvisor Web App on Behavioral Symptoms and Caregiver Outcomes: A Randomized Trial. J Am Geriatr Soc. 2026 Aug 6. doi: 10.1111/jgs.70637. Online ahead of print.
PubMed 42561014
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons Living With Dementia
- ClinicalTrials.gov ID
- NCT05012410
- Acronym / sponsor ID
- 2007007999
- Conditions
- Dementia, Caregiver Burnout, Caregiver Stress Syndrome, Alzheimer Disease, Frontotemporal Dementia, Vascular Dementia
- Keywords
- dementia, caregiver, alzheimer's disease, memory loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis, National Institute on Aging (NIA), Johns Hopkins University
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 19 Aug 2021 (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.
The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia. The trial will evaluate its efficacy to reduce caregiver distress, improve confidence managing behaviors, as well as reduce occurrences and severity of behavioral and psychological symptoms.
Visit https://wecareadvisorstudy.com/ for more information.
Detailed description
Caregivers enrolled in the study will use the web-based WeCareAdvisor tool for either three or six months, depending upon group allocation (immediate treatment vs. 3-month waitlist). Caregivers will be interviewed at baseline, 1, 3 and 6 months by telephone to evaluate their health and wellbeing. Also, utilization data of the tool will be captured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective randomized trial involving an immediate treatment group (Group A) and a 3-month waitlist control group (Group B). Also, groups will be randomized to different prompting conditions (email only, telephone and email) to remind participants to use the tool.
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment group with High-Intensity Prompts | Experimental | Behavioral: Immediate treatment group with High-Intensity PromptsCaregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts. |
| Immediate treatment group with Low-Intensity Prompts | Experimental | Behavioral: Immediate treatment group with Low-Intensity PromptsCaregivers will use the WeCareAdvisor tool for six months and receive email prompts only. |
| Waitlist Control after three months with high-Intensity prompts | Experimental | Behavioral: Waitlist Control after three months with High-Intensity PromptsAfter three months, caregivers will receive WeCareAdvisor and telephone and email prompts. |
| Waitlist Control after three months with Low-Intensity Prompts | Experimental | Behavioral: Waitlist Control after three months with Low-Intensity PromptsAfter three months, caregivers will receive WeCareAdvisor and email prompts only. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- self-identify as the primary caregiver to the person living with memory loss or dementia;
- has been a primary caregiver for at least 6 months;
- report managing >1 behavioral symptom(s) in the past month;
- has an email account or smartphone (to receive daily tips and reminder messages);
- English speaking;
Key exclusion criteria (6 listed)
- Caregiver currently involved in another clinical trial of psychosocial or educational interventions for dementia;
- Caregiver has a visual impairment that prohibits interaction with the tool, and/or have a hearing impairment sufficient to prohibit telephone communication;
- Caregiver reports person living with dementia is not responsive to his/her environment (e.g., unable to understand short commands or recognize a person coming in/out of the room);
- Caregiver reports person living with dementia is an active suicide risk
- Caregiver reports person living with dementia is likely to have an imminent placement in a long-term care facility (within 6 months).
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 |
|---|---|---|
| Immediate treatment group with High-Intensity PromptsCaregivers in the immediate treatment group with high-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive telephone and email prompts to use the tool. | Behavioural | Immediate treatment group with High-Intensity Prompts |
| Immediate treatment group with Low-Intensity PromptsCaregivers in the immediate treatment group with low-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive email prompts to use the tool. | Behavioural | Immediate treatment group with Low-Intensity Prompts |
| Waitlist Control after three months with High-Intensity PromptsAfter 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive telephone and email prompts. Once the caregiver receives the WeCareAdvisor tool, they will receive a weekly automated email as well as a weekly telephone call from study staff to prompt them to use the tool. | Behavioural | Waitlist Control after three months with high-Intensity prompts |
| Waitlist Control after three months with Low-Intensity PromptsAfter 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive email prompts. | Behavioural | Waitlist Control after three months with Low-Intensity Prompts |
Primary outcome
Short-term Change in Caregiver Distress with Behaviors
Time frame: 1 Month
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Long-term Change in Caregiver Distress with Behaviors (3-Months)
Time frame: 3 months
For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)
Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
Time frame: 1 month
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 = low confidence - 10= high confidence)
Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
Time frame: 3 months
Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 (low-confidence - 10- high-confidence))
Short-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
Time frame: 1 Month
Neuropsychiatric Inventory-Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
Long-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity
Time frame: 3 Months
Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)
16 secondary outcomes
Short-Term Change in Person with Dementia- Level of Functioning
Time frame: 1 months
Long-Term Change in Person with Dementia- Level of Functioning
Time frame: 3 months
Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia
Time frame: 1 months
Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia
Time frame: 3 months
Change in Person with Dementia's Medications
Time frame: 6 months
Short Term Change in Caregiver Wellbeing
Time frame: 1 Month
Long Term Change in Caregiver Wellbeing
Time frame: 3 Months
Short Term Change in Caregiver- Negative Communications
Time frame: 1 Month
Long Term Change in Caregiver- Negative Communications
Time frame: 3 Month
Utilization of tool use
Time frame: Through study completion, up to 6 months.
Short-Term Change in Person Living with Dementia- Frequency of Behaviors
Time frame: 1 months
Long-Term Change in Person Living with Dementia- Frequency of Behaviors
Time frame: 3 months
Short-Term Change in Person Living with Dementia- Severity of Behaviors
Time frame: 1 months
Long-Term Change in Person Living with Dementia- Severity of Behaviors
Time frame: 3 months
Short-Term Change in Person Living with Dementia- Number of Behaviors
Time frame: 1 months
Long-Term Change in Person Living with Dementia- Number of Behaviors
Time frame: 3 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 30 Sep 2025.
- Background: PubMed 33786370Gitlin LN, Bouranis N, Kern V, Koeuth S, Marx KA, McClure LA, Lyketsos CG, Kales HC. WeCareAdvisor, an Online Platform to Help Family Caregivers Manage Dementia-Related Behavioral Symptoms: an Efficacy Trial in the Time of COVID-19. J Technol Behav Sci. 2022;7(1):33-44. doi: 10.1007/s41347-021-00204-8. Epub 2021 Mar 25.
- Results publication: 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.
- Results publication: 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 42767991Gitlin LN, McClure LA, Webster MJ, Lyketsos C, Kales HC. Timing Matters: Effects of Delayed versus Immediate Access to a Web-Based Application on Caregiver Outcomes: The WeCareAdvisor Trial. Gerontologist. 2026 Sep 21:gnag226. doi: 10.1093/geront/gnag226. Online ahead of print.
- Derived from this study: PubMed 42561014Gitlin LN, McClure LA, Webster MJ, Lyketsos C, Kales HC. Effects of the WeCareAdvisor Web App on Behavioral Symptoms and Caregiver Outcomes: A Randomized Trial. J Am Geriatr Soc. 2026 Aug 6. doi: 10.1111/jgs.70637. Online ahead of print.
- Individual participant dataSharing planned: No. Data will be stored after 7 years following completion of study and reporting of main outcomes.
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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.
Laura N Gitlin, PhD principal investigator
Drexel University
Helen C Kales, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate treatment group with High-Intensity Prompts and Immediate treatment group with Low-Intensity Prompts in people with Dementia and Caregiver Burnout, run by Drexel University 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 9 inclusion and 6 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 30 Sep 2025. 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.
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?
Short-term Change in Caregiver Distress with Behaviors (time frame: 1 Month). The study lists 6 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 NCT05012410, which also lists 5 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 30 Sep 2025.