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Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home (PLAN-Home)

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Johns Hopkins University

Status

Withdrawn

Conditions

Dementia

Treatments

Behavioral: PLAN - Home

Study type

Interventional

Funder types

Other

Identifiers

NCT05225818
IRB00299252

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Experimental: PLAN - Home
Experimental group
Description:
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.
Treatment:
Behavioral: PLAN - Home
No intervention: Control Group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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