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Behavioural Intervention
Caregiver Training with MapHabit for Alzheimer's Disease
N/A
Waitlist Available
Led By Stuart Zola
Research Sponsored by MapHabit, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-post: the assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
Awards & highlights
Study Summary
This trial will study whether or not a new Alzheimer's disease technology called MapHabit, which uses visual maps to improve a patient's behavior and sense of autonomy, can reduce caregiver burden when used with a caregiver training program. A total of 50 patient-caregiver dyads will be studied over a 6-month period, with half receiving MapHabit and half receiving usual care.
Who is the study for?
This trial is for English-speaking primary caregivers of individuals with mild to moderate Alzheimer's or related dementias. The patient-caregiver pairs will participate in a program aimed at reducing caregiver burden and enhancing the autonomy of the person with dementia.Check my eligibility
What is being tested?
The study tests the MapHabit System (MHS), an assistive technology using visual maps, combined with a Caregiver Training Program (CTP). It compares outcomes between those using just MHS and those using MHS+CTP over six months, involving 50 patient-caregiver pairs.See study design
What are the potential side effects?
Since this trial involves a training program and assistive technology rather than medication, traditional side effects are not expected. However, participants may experience frustration or stress if they find it difficult to use the system or do not perceive improvements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-post: the assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-post: the assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months
Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months
Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months
+3 moreSecondary outcome measures
2-item Satisfaction Scale (SS-2)
Anger Management Scale
Generalized Anxiety Disorder (GAD7) Scale
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Caregiver Training ProgramExperimental Treatment1 Intervention
This condition will involve the implementation of an assistive technology software (named the MapHabit System) with an added Caregiver Training Program into the daily care of individuals with mild to moderate stages of Alzheimer's disease and related dementias. The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). The application will be made available to families through compatible tablets.
Group II: The MapHabit SystemActive Control1 Intervention
This control condition will act as the active comparator to the experimental condition. The same assistive technology, the MapHabit System, will be given to a separate group of participants. The difference here will be that the software will be a version that does not include the caregiver training program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
The MapHabit System
2020
N/A
~30
Find a Location
Who is running the clinical trial?
MapHabit, Inc.Lead Sponsor
3 Previous Clinical Trials
74 Total Patients Enrolled
1 Trials studying Assistive Technology
32 Patients Enrolled for Assistive Technology
LiveWellUNKNOWN
Stuart ZolaPrincipal InvestigatorMapHabit, Inc.
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Assistive Technology
32 Patients Enrolled for Assistive Technology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English.I have been diagnosed with Alzheimer's or similar dementia at a mild to moderate stage.I have not been diagnosed with Alzheimer's or related dementias.
Research Study Groups:
This trial has the following groups:- Group 1: Caregiver Training Program
- Group 2: The MapHabit System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What primary goals are being pursued by this medical experiment?
"The primary endpoint of this trial will be a measure of the Zarit Burden Assessment Caregiver Strain instrument, conducted before and after 6 months. Secondary assessments include changes in pain levels via the Pain and Sleep Questionnaire, Generalized Anxiety Disorder (GAD7) Scale to evaluate generalised anxiety disorder symptoms, as well as the 2-item Satisfaction Scale (SS-2), which gauges patient satisfaction with their MHS experience."
Answered by AI
Is the application window for this clinical trial still open to prospective participants?
"According to information available on clinicaltrials.gov, this particular trial is closed for recruitment as of September 1st 2022. Originating from February 1st 2024, the study has since concluded its candidate search; however, there are 796 other trials that are actively inviting participants at this time."
Answered by AI
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