Clinical trial NCT05527405: Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes
Official title: Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Caregiver Burden
Assistive Technology
Keywords: Alzheimer Disease
Dementia
Caregiver Burden
Activities of Daily Living
Assistive Technology
Lead sponsor: MapHabit, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized controlled clinical trial in which two conditions will be investigated: a control and an experimental condition.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in User Interaction and Engagement from baseline at 6 months
timeFrame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up..
measure: Change in Zarit Burden Assessment Caregiver Strain instrument from baseline at 6 months
timeFrame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
measure: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months
timeFrame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
measure: Change in Quality of Life - 18 (QoL-18) from baseline at 6 months
timeFrame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
measure: Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months
timeFrame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
measure: Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months
timeFrame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
Secondary outcomes:
measure: 2-item Satisfaction Scale (SS-2)
timeFrame: The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)
measure: Pain and Sleep Questionnaire
timeFrame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
measure: Generalized Anxiety Disorder (GAD7) Scale
timeFrame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
measure: Anger Management Scale
timeFrame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: MapHabit, Inc.
state: Georgia
Study officials:
affiliation: MapHabit, Inc.
name: Stuart Zola
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.