Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home Pilot
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Johns Hopkins University
- Locations
- 1
- Primary Endpoint
- Number of participants linked to medical service for dementia
Study Overview
Brief Summary
Rapid growth in elderly population and higher prevalence of dementia necessitates further attention to dementia. Even though early detection and continuing care are mainstays of dementia care, limited access to dementia diagnosis and dementia care planning for elders could be attributed to factors like low dementia literacy-the capacity to obtain, process, and understand basic dementia-related information and services to make appropriate health decisions-and lack of social support. Developing innovative pathways to transition families of individuals with probable dementia into healthcare access for early diagnosis of dementia and timely dementia care planning can benefit patients and the patients' families. To this end, the investigators' study aims are to develop a home-based intervention program for dementia evaluation, education, and care planning and test its feasibility and acceptability in a pilot study.
Detailed Description
This research is being done to understand how an education and navigation support program led by trained Nurse Practitioners (NPs) helps older adults with probable dementia and the patients' caregivers. In a 2-arm randomized controlled trial (RCT) with 40 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained NPs for undiagnosed older adults with probable dementia and the patients' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to a group of participants who receive a copy of the publicly available educational material, and (3) examine whether the effect of PLAN differs across age, sex, and education caregiver subgroups.
Aim 1 tests the following hypotheses: older adults with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group. Aim 2 tests the following hypothesis: caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 65 years or older
- •Enrolled in home-based primary care
- •Mini-Mental State Exam (MMSE) <24
- •Has a caregiver who lives in the same household or has at least weekly interactions
- •Able to consent or has a proxy available for consent
- •Written consent to participate in the study
- •Inclusion Criteria (Caregiver):
- •Age 18 years or older
- •Able to read, write, and speak English
- •Lives in the same household with an older adult with MMSE <24 or has at least weekly interactions
- •Written consent to participate in the study
Exclusion Criteria
- •Previous dementia diagnosis
- •All Axis I diagnoses other than depressive disorders (e.g., schizophrenia, bipolar disorder, or substance use disorder)
- •Neurological disorders other than Alzheimer's disease that might affect cognition (e.g., stroke)
- •Use of psychotropic drugs including antipsychotics
- •Exclusion Criteria (Caregiver):
- •Plan to move from the area within 6 months
- •Active treatment for a terminal illness or in hospice
Arms & Interventions
Experimental: PLAN - Home
Trained NPs will deliver the PLAN-Home to the enrolled participants, which consists of home-based dementia evaluation, education, and care planning for older adults with probable dementia.
Intervention: PLAN - Home (Behavioral)
No intervention: Control Group
The control group will receive a copy of the publicly available educational material on 10 warning signs and symptoms of Alzheimer's disease and action steps prepared by Alzheimer's Association.
Outcomes
Primary Outcomes
Number of participants linked to medical service for dementia
Time Frame: 6 months
Number of participants linked to medical service for dementia measured by medical record verification. Linkage to medical service for dementia is defined as having had primary care or specialty care provider evaluation for cognitive impairment.
Secondary Outcomes
- Number of participants who complete advanced directives(6 months)
- Change in functional ability for instrumental activities of daily living as assessed by Lawton-Brody scores(Baseline and 6 months)
- Change in Patient quality of life as assessed by Quality of Life-Patient scores (for all patient participants)(Baseline and 6 months)
- Change in Social Support as assessed by Medical Outcomes Study (MOS)-Social Support survey scores (for all caregiver participants)(Baseline and 6 months)
- Program satisfaction as assessed by study questionnaire(6 months)
- Change in functional ability for activities of daily living as assessed by Katz scores(Baseline and 6 months)
- Change in self-efficacy as assessed by Self-Efficacy Dementia Scale scores(Baseline and 6 months)
- Change in Caregiver Quality of Life(Baseline and 6 months)
- Change in Dementia Literacy as assessed by Rapid Estimate of Adult Literacy in Medicine (REALM)-Dementia scores (for all caregiver participants)(Baseline and 6 months)
- Number of participants who complete a plan for dementia care(6 months)
- Change in depression as assessed by Patient Health Questionnaire-2 (for all caregiver participants)(Baseline and 6 months)