Clinical trial NCT05225818: Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home
Official title: Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Keywords: Nurse Practitioners
Diagnosis
Social Support
Patient Education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria (Patient):

* 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 (Patient):

* 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

Primary outcomes:
measure: Number of participants linked to medical service for dementia
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants who complete a plan for dementia care
timeFrame: 6 months
measure: Number of participants who complete advanced directives
timeFrame: 6 months
measure: Change in functional ability for activities of daily living as assessed by Katz scores
timeFrame: Baseline and 6 months
measure: Change in functional ability for instrumental activities of daily living as assessed by Lawton-Brody scores
timeFrame: Baseline and 6 months
measure: Change in Patient quality of life as assessed by Quality of Life-Patient scores (for all patient participants)
timeFrame: Baseline and 6 months
measure: Change in Dementia Literacy as assessed by Rapid Estimate of Adult Literacy in Medicine (REALM)-Dementia scores (for all caregiver participants)
timeFrame: Baseline and 6 months
measure: Change in Social Support as assessed by Medical Outcomes Study (MOS)-Social Support survey scores (for all caregiver participants)
timeFrame: Baseline and 6 months
measure: Change in depression as assessed by Patient Health Questionnaire-2 (for all caregiver participants)
timeFrame: Baseline and 6 months
measure: Change in self-efficacy as assessed by Self-Efficacy Dementia Scale scores
timeFrame: Baseline and 6 months
measure: Change in Caregiver Quality of Life
timeFrame: Baseline and 6 months
measure: Program satisfaction as assessed by study questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Haera Han, PhD
role: PRINCIPAL_INVESTIGATOR
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