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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

No Placebo-Only Group

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.

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.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-post: the assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

2-item Satisfaction Scale (SS-2)

Anger Management Scale

Generalized Anxiety Disorder (GAD7) Scale

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

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