Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

Not Applicable

Not yet recruiting

• Conditions: Assistive Technology; Dementia; Alzheimer Disease; Caregiver Burden

• Registration Number: NCT05527405
• Lead Sponsor: MapHabit, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Study Start: 2024-03
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life - 18 (QoL-18) from baseline at 6 months	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.	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.
Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.	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.
Change in User Interaction and Engagement from baseline at 6 months	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up..	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.
Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.	12-item, caregiver self-report measure of stress levels
Change in Zarit Burden Assessment Caregiver Strain instrument from baseline at 6 months	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.	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.
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months	Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
2-item Satisfaction Scale (SS-2)	The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)	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.
Anger Management Scale	Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.	12-item questionnaire designed to monitor and evaluate progress in controlling and managing anger
Pain and Sleep Questionnaire	Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.	5-item questionnaire developed to assess the impact of pain on quality of sleep
Generalized Anxiety Disorder (GAD7) Scale	Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.	7-item questionnaire used as an initial screening tool for generalized anxiety disorder

Trial Locations

Locations (1)

MapHabit, Inc.; 🇺🇸 Atlanta, Georgia, United States