Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05225818
Status:
WITHDRAWN
Last Update Posted:
2022-07-01
First Post:
2022-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home Pilot
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Our study design changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAN-Home
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: