Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes
- Conditions
- Assistive TechnologyDementiaAlzheimer DiseaseCaregiver Burden
- Interventions
- Device: The MapHabit System
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
- Arm && Interventions
Group Intervention Description The MapHabit System The MapHabit System 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. Caregiver Training Program The MapHabit System 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.
- 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