Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care
- Conditions
- CaregiverNeurocognitive DisordersAlzheimer Disease
- Interventions
- Other: CareHeroes
- Registration Number
- NCT04571502
- Lead Sponsor
- Florida International University
- Brief Summary
Alzheimer's disease and related dementias (ADRD) are leading causes of disability and often result in communication deficits of the person with dementia (PWD) that can complicate ADRD caregiving and clinical care. The research team will work with stakeholders to develop and design a personalized Assistive and Alternative Communication (AAC) device that relies on information technology (IT) and touchscreens to promote communication and personhood for PWD about their care preferences and experiences. This study will integrate the AAC into an existing health IT intervention that already facilitates clinical communication between caregivers and providers of PWD. A clinical trial will be conducted to evaluate outcomes of 58 dyads (PWD/caregivers) and their health care provider utilizing the My PATI (My Person Assisted Touchscreen Interface)intervention as an adjunct to care and care giving for 6 months.
- Detailed Description
The target enrollment for the clinical trial is 58 dyads of caregivers and people with dementia (PWD), where 58 unique dyads of caregivers/PWD will participate. The team plans to enroll a total of 58 dyads across two participating clinical sites. Participants will be randomly assigned to either the full intervention or a control condition for a period of 6 months, where they will be asked to communicate clinical and other relevant information with one another as part of regular caregiving and clinical care activities. Several psychosocial outcome variables for providers, caregivers, and PWD will be assessed. We will compare outcomes based on group assignment and different amounts and patterns of use of the MyPATI (e.g., minimal/non-users versus frequent users). The primary outcome variables are quality of life for caregivers and PWD. The research team will recruit an estimated 15 healthcare providers across both sites at the end of study to assess their experience with My PATI using open and closed ended queries.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minimal Intervention CareHeroes TRIADs (caregiver, PWD, and provider) randomly assigned to the minimal intervention arm will have access to use CareHeroes but only a paper version of the newly developed AAC app. Full Intervention CareHeroes TRIADs (caregiver, PWD, and provider) randomly assigned to the experimental arm will have access to use CareHeroes AND the newly developed AAC app. Provider will receive information via the AAC app.
- Primary Outcome Measures
Name Time Method Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview) Baseline, 3-months, 6- months The 13-item QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the care recipient's physical health, mood, relationships, activities, and ability to complete tasks. The Care Recipient (self-assesses) and caregiver (proxy-interview) complete the QOL-AD.
Change in Perceived Change Index- Caregiver QOL Baseline, 3-months, 6- months A 13-item scale that measures caregiver appraisals of self-improvement or decline in distinct areas of well- being. Caregiver indicates whether each item has become worse, stayed the same, or improved in the past month: feeling rested, ability to have time for yourself, and feelings of being upset. The total and subscales (Affect, Somatic, and Ability to Manage)
- Secondary Outcome Measures
Name Time Method Change in Oberved PHQ-9 Caregiver Interviewed about Care Recipient Baseline, 6-months The PHQ-9 observed version is a depression severity measure used for screening for mood disorders in nursing home populations (Saliba et al, 2012). The 9 signs and symptoms are assessed by interviewing an informant about their observations of client symptoms over the previous 2 weeks.
Change in PATIENT HEALTH QUESTIONNAIRE (PHQ-9)- Caregiver Baseline, 3-months, 6- months The 9-item Patient Health Questionnaire (PHQ-9) includes nine items that correspond to each of the nine symptoms of major depression from the Diagnostic and Statistical Manual of Mental Disorders. The PHQ-9 scores range from 0 to 27 (increasing score correlates with increasing depression severity) and each of the 9 items is scored from 0 to 3, indicating "how often a symptom is bothersome."
Change in The Positive Aspects of Caregiving Scale- Caregiver Baseline, 3-months, 6- months The Positive Aspects of Caregiving Scale (Tarlow et al., 2004) assesses positive feelings resulting from care provision among family caregivers of older adults with functional limitations. Each of the 9 items on the scale asks about potential benefits from caregiving for the caregivers.
Change in Zarit Caregiver Burden Inventory-22 items (ZBI-22)- Caregiver Baseline, 3-months, 6-months The ZBI-22 (22 items) assesses common stressors experienced by dementia caregivers. A list of statements which reflect how people sometimes feel when taking care of another person are presented and caregivers are queried about how often they felt that way (never, rarely, sometimes, quite frequently, or nearly always).
Change in 12 Item Short-Form Health Survey (SF-12) - Caregiver Baseline,6-months The SF-12 is a validated, shortened version of the The RAND Health Care 36-Item Health Survey that includes 7 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Change in The Revised Memory and Behavior Problems Checklist - Caregiver interviewed about Care Recipient Baseline, 6-months The Revised Memory and Behavior Problems Checklist, a 24-item caregiver-reported measure of observable memory difficulties and behavior problems in patients along with a parallel assessment of the caregiver's reaction to these behavioral problems. The checklist is a reliable and valid assessment that asks the caregiver to rate the frequency of care recipient problems (0 = never occurred to 4 = daily or more often) within three subscales (i.e., memory-related, depression, and disruptive behaviors). The caregiver rates the frequency of each behavior problem during the past week and his/her reaction to the behavior (i.e., how bothered or upset the caregiver feels when the behavior occurs \[0 = not at all to 4 = extremely bothered\]).
Change in Geriatric Depression Scale (GDS-15)- Care Recipient Baseline, 6-months The 15-item Geriatric Depression Scale (GDS-15) is a depression screening tool developed for use in older adults. It had been validated for community-dwelling, hospitalized, and institutionalized older adults. The GDS-15 has a yes-no format. Scores range from 0 to 15; the higher the score the more likely the individual is experiencing depression.
Change in Partner-Patient Questionnaire for Shared Activities-Caregiver interviewed about relationship with Care Recipient Baseline, 3 Months, 6 Months The PPQSA was constructed to measure the extent to which the AD patient's mood and mental state interfered with the patient-partner relationship.
Change in Functional Linguistic Communication Inventory (FLCI)- Care Recipient Baseline Functional Linguistic Communication Inventory (FLCI) is a standardized instrument for evaluating functional communication in persons with moderate and severe dementia. A number of domains assessed included: Greeting and naming, Answering questions, Writing, Sign comprehension, Object-to-picture matching, Word reading and comprehension, Reminiscing, Following commands, Pantomime, Gesture, and Conversation.
My PATI Usage - Links clicked on the app, resources accessed 6 months The research team will track user actions ( provider, caregiver, care recipient) on the Web and Android/iphone operating system Apps, such as login, logout, viewing of educational material, taking a health assessment, or contacting the provider.
Provider Interviews 6 months The research team will conduct interviews with the providers who are participating with intervention dyads. The interview questions will include newly-created closed-ended questions, and open-ended qualitative questions that will assess their perceptions of integrating My PATI into clinical workflow (e.g. acceptability of technology, problems experienced, observed benefits); and how use of My PATI influenced clinical/shared decision making and clinical care.
My PATI Usage- Links clicked on the app, resources accessed 6 months The research team will track user actions ( provider, caregiver, care recipient) on the Web and Android/IOS Apps, such as login, logout, viewing of educational material, taking a health assessment, or contacting the provider.
Trial Locations
- Locations (2)
UAB Alzheimer's Risk Assessment and Intervention Clinic
🇺🇸Birmingham, Alabama, United States
Miami Jewish Health
🇺🇸Miami, Florida, United States