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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: PLAN - Home


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: PLAN - Home<br>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<br>* home-based intervention program for dementia evaluation, education, and care planning<br>|
| No Intervention: No intervention: Control Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants linked to medical service for dementia | 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 | Completion of a plan for dementia care is measured by study questionnaire: yes or no. | 6 months | 
| Number of participants who complete advanced directives | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nurse Practitioners, Diagnosis, Social Support, Patient Education