Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes (NCT05527405) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes
United States50 participantsStarted 2024-08-24
Plain-language summary
As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system (MHS) will offer a caregiver training product in adjunct. MHS is an Alzheimer's disease or related dementias (ADRD) assistive technology product that uses visual maps to improve the quality of life of persons living with dementia (PLWD) and reduce the burden of care partners. The study will primarily investigate the efficacy of the Caregiver Training Program (CTP), a personalized dementia caregiver education service that is integrated into the MHS product. The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the MHS alone is incorporated in the caregiver's daily care for PLWD and 2) experimental condition in which the MHS+CTP is implemented into the caregiver's daily care for PLWD.
The sample size will be a total of 50 caregiver-PLWD dyads, 25 in each condition. This means the primary participant will be the caregiver, while the PLWD under the caregiver's care is considered the co-participant. Hence, 50 participant dyads enrolled will equate to 100 participants enrolled total. The study will be a 6-month intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participating caregiver of individual with dementia must be the primary caregiver
* Care recipient must be an individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
* Proficient in English
Exclusion Criteria:
* Participating caregiver of individual with dementia is NOT the primary caregiver
* Care/support recipient not diagnosed with ADRD
* Not proficient in English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is completed and measured caregiver burden using the Zarit Burden Interview — has my doctor seen the results, and do they suggest this type of caregiver training program actually reduced how overwhelmed caregivers felt after 6 months?
2The trial looked at the patient's ability to carry out daily activities using the ADCS-ADL scale — is there any published data showing whether the assistive technology and training approach helped people with Alzheimer's or dementia maintain those skills, and would that be relevant for my loved one's current stage?
3Since this study trained caregivers in recognizing and managing signs and symptoms, is a structured caregiver training program something my doctor would recommend for our family right now, or is there a standard care approach we should try first?
4The trial measured caregiver well-being and confidence alongside patient outcomes — given how much caregiving affects our whole family, does my doctor think a program like this would be a better fit than what support resources we currently have access to?
5This trial has already completed — does my doctor know if the results are published or presented anywhere, and if the findings were promising, is there a similar program currently available that we could actually participate in?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Zarit Burden Interview at 6 Months
Timeframe: Pre-Post: The instrument is administered to the participants at 6 months
2
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) at 6 Months
Timeframe: The instrument is administered to the participants at 6 months
3
Quality of Life - 18 (QoL-18) at 6 Months
Timeframe: The instrument is administered to the participants at 6 months
4
Rapid Caregiver Well-Being Scale (R-CWBS) at 6 Months
Timeframe: The instrument is administered to the participants at 6 months
5
Caregiver Confidence in Sign/Symptom Management (CCSM) Scale at 6 Months
Timeframe: The instrument is administered to the participants at 6 months