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NCT05527405 · ClinicalTrials.gov registry record · NA
Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes
A NA study of Alzheimer Disease and Dementia, sponsored by MapHabit.
- Active
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05527405: Active NA study of Alzheimer Disease and Dementia, sponsored by MapHabit.
NCT05527405 is a NA study of Alzheimer Disease and Dementia that is active but no longer recruiting, run by MapHabit. The registered enrollment target is 50 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05527405, a NA study of Alzheimer Disease and Dementia, is active but no longer recruiting, sponsored by MapHabit.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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 that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. MapHabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with AD/ADRD. Additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the Caregiver Training Program (CTP) experience.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 participant's daily care and 2) experimental condition in which the MHS+CTP is implemented into the daily care received by participants. The sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. The study duration will be a 6-month intervention.
Primary Outcome
The instrument consists of 22 items that evaluate the caregiver's perceived emotional, social, and physical burden. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Nearly Always). Total scores range from 0 to 88, with higher scores indicating greater caregiver burden. The total score is calculated by summing responses across all items.
Conditions Studied
Interventions
- DEVICE The MapHabit System
Study Locations (1)
Georgia
- MapHabit, Inc. - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-08-24 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT05527405 still lists
NCT05527405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which The MapHabit System is the first listed.
NCT05527405 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05527405 about?
NCT05527405 is a clinical study titled "Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes". 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 that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visu...
What is the current status of trial NCT05527405?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-08-24. Estimated completion is 2025-12-31.
What conditions does trial NCT05527405 study?
This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Caregiver Burden, Assistive Technology.
What interventions are being tested in trial NCT05527405?
The interventions under investigation include: The MapHabit System (DEVICE).
Who is sponsoring clinical trial NCT05527405?
This trial is sponsored by MapHabit, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05527405 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05527405's enrollment target sits among peer trials
50 210th of 306 higher than 93 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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