Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

Alzheimer Disease Clinical Trial

Official title:

Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05527405
• Other study ID #: Fast Track - CTP (NIH-SBIR)
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: MapHabit, Inc.
• Contact: Brittany Montgomery, MS
• Phone: 6786206171
• Email: bmontgomery[@]maphabit.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment

• Participating caregiver of individual with dementia must be the primary caregiver

• Proficient in English

Exclusion Criteria:

• Individual not diagnosed with ADRD

• Participating caregiver of individual with dementia is NOT the primary caregiver

• Not proficient in English

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Dementia

Intervention

Device:
• The MapHabit System
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 goal of the application is to develop and facilitate habits and routines using structured visual and auditory stimuli that can be customized by the user and can include educational and lesson-based material in addition to ADLs. The application will be made available to families through compatible smartphones and tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified content and structure. The MHS is a general wellness product and there is no regulatory oversight of the MapHabit System mapping functionality. This functionality is not a regulated medical device.

Locations

Country	Name	City	State
United States	MapHabit, Inc.	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
MapHabit, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980. — View Citation

Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165. — View Citation

Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in User Interaction and Engagement from baseline at 6 months	18-item quality-of-life questionnaire (QoL-18) evaluates a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-10. A higher number indicates better outcome.	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up..
Primary	Change in Zarit Burden Assessment Caregiver Strain instrument from baseline at 6 months	18-item questionnaire assessing the various stresses caregivers experienced relating to caring for an individual with cognitive impairment. The total score ranges from 0-72, with a higher score reflecting higher stress and burden on the caregiver.	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
Primary	Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months	Assesses an individual with dementia's ability to carry out activities of daily living. The total score ranges from 0-53, with a higher score representing better performance in completing activities of daily living by the individual with dementia.	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
Primary	Change in Quality of Life - 18 (QoL-18) from baseline at 6 months	18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the middle and end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-10. A higher number indicates better outcome.	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
Primary	Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months	8-items selected from the Wisconsin Quality of Life Caregiver Questionnaire evaluated a range of participants' behaviors, including mood, engagement, and memory at the middle and end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-10. A higher number indicates better outcome.	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
Primary	Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months	12-item, caregiver self-report measure of stress levels	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
Secondary	2-item Satisfaction Scale (SS-2)	Quantifies caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others? Both questions are scored on a 10-point scale, with a higher value reflecting a better outcome/experience.	The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)
Secondary	Pain and Sleep Questionnaire	5-item questionnaire developed to assess the impact of pain on quality of sleep	Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
Secondary	Generalized Anxiety Disorder (GAD7) Scale	7-item questionnaire used as an initial screening tool for generalized anxiety disorder	Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
Secondary	Anger Management Scale	12-item questionnaire designed to monitor and evaluate progress in controlling and managing anger	Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.