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

June 28, 2022 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • The Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: PLAN - Home
home-based intervention program for dementia evaluation, education, and care planning
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who complete a plan for dementia care
Time Frame: 6 months
Completion of a plan for dementia care is measured by study questionnaire: "yes" or "no".
6 months
Number of participants who complete advanced directives
Time Frame: 6 months
Completion of advanced directives is measured by study questionnaire: "yes" or "no".
6 months
Change in functional ability for activities of daily living as assessed by Katz scores
Time Frame: Baseline and 6 months
The Katz Index of Independence in Activities of Daily Living is a 7-item instrument, with 1 point assigned for each item respondents are able to perform independently without supervision, direction, or guidance. Scores range from 0 to 6 with higher scores indicating higher independence.
Baseline and 6 months
Change in functional ability for instrumental activities of daily living as assessed by Lawton-Brody scores
Time Frame: Baseline and 6 months
The Lawton-Brody Instrumental Activities of Daily Living Scale is an 8-domain instrument (5 domains historically used for men), with 1 point assigned for each statement that reflects higher levels of functioning. Summary scores range from 0 to 8 (5 for men) with higher scores indicating higher functioning and independence.
Baseline and 6 months
Change in Patient quality of life as assessed by Quality of Life-Patient scores (for all patient participants)
Time Frame: Baseline and 6 months
QoL-dementia older adult is a 13-item instrument and scoring ranges from "poor" coded as 1 to "excellent" coded as 4 for each item. Total scores will range from 13 to 52 with higher scores indicating higher 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)
Time Frame: Baseline and 6 months
The dementia literacy test is a 11-item instrument. Scoring of the dementia literacy instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores can range from 0 to 11 with higher scores indicating higher dementia literacy.
Baseline and 6 months
Change in Social Support as assessed by Medical Outcomes Study (MOS)-Social Support survey scores (for all caregiver participants)
Time Frame: Baseline and 6 months
The 8-item scale of medical outcomes study scoring ranges from "none of the time" coded as 1 to "all of the time" coded as 5 for each item. Total scores will range from 8 to 40 with higher scores indicating higher social support.
Baseline and 6 months
Change in depression as assessed by Patient Health Questionnaire-2 (for all caregiver participants)
Time Frame: Baseline and 6 months
Patient health questionnaire-2 is a 2-item instrument and scoring ranges from "not at all" coded as 0 to "nearly every day" coded as 3. Total scores will range from 0 to 6 with higher score indicating greater depressive symptoms.
Baseline and 6 months
Change in self-efficacy as assessed by Self-Efficacy Dementia Scale scores
Time Frame: Baseline and 6 months
Dementia self-efficacy scale is a 10-item instrument. Scoring of the dementia self-efficacy scale ranges from "not at all certain" coded as 1 to "very certain" coded as 10 for each item. Total scores will range from 10 to 100 with higher scores indicating higher self-efficacy.
Baseline and 6 months
Change in Caregiver Quality of Life
Time Frame: Baseline and 6 months
QoL-dementia caregiver is a 13-item instrument and scoring ranges from "poor" coded as 1 to "excellent" coded as 4 for each item. Total scores will range from 13 to 52 with higher scores indicating higher quality of life.
Baseline and 6 months
Program satisfaction as assessed by study questionnaire
Time Frame: 6 months
Caregiver satisfaction with the intervention program will be measured on a 10-point visual analogue scale, with scoring ranges from 0 "not at all satisfied" to 10 "extremely/highly satisfied". Higher scores will indicate greater satisfaction with program.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Haera Han, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00299252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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