Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- MapHabit, Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in User Interaction and Engagement from baseline at 6 months
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Stuart Zola
Chief Scientific Officer
MapHabit, Inc.
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
Outcomes
Primary Outcomes
Change in User Interaction and Engagement from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (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.
Change in Zarit Burden Assessment Caregiver Strain instrument from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (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.
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (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.
Change in Quality of Life - 18 (QoL-18) from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (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.
Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (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.
Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
12-item, caregiver self-report measure of stress levels
Secondary Outcomes
- 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))
- Pain and Sleep Questionnaire(Pre-Post: The assessment will be administered at baseline, post-intervention (6 months))
- Generalized Anxiety Disorder (GAD7) Scale(Pre-Post: The assessment will be administered at baseline, post-intervention (6 months))
- Anger Management Scale(Pre-Post: The assessment will be administered at baseline, post-intervention (6 months))