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

NCT05225818 | Withdrawn DMC

• 1 other identifier: IRB00299252
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Nurse Practitioners; Diagnosis; Social Support; Patient Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of participants who complete a plan for dementia care

  6 months

• Number of participants who complete advanced directives

  6 months

• Change in functional ability for activities of daily living as assessed by Katz scores

  Baseline and 6 months

• Change in functional ability for instrumental activities of daily living as assessed by Lawton-Brody scores

  Baseline and 6 months

• Change in Patient quality of life as assessed by Quality of Life-Patient scores (for all patient participants)

  Baseline and 6 months

Study Arms (2)

Experimental: PLAN - Home

EXPERIMENTAL

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

No intervention: Control Group

NO INTERVENTION

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.

Interventions

PLAN - Home BEHAVIORAL

home-based intervention program for dementia evaluation, education, and care planning

Experimental: PLAN - Home

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Plan to move from the area within 6 months
• Active treatment for a terminal illness or in hospice

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Related Publications (20)

• Robinson L, Tang E, Taylor JP. Dementia: timely diagnosis and early intervention. BMJ. 2015 Jun 16;350:h3029. doi: 10.1136/bmj.h3029. No abstract available.

  PMID: 26079686 BACKGROUND

• Landers S, Madigan E, Leff B, Rosati RJ, McCann BA, Hornbake R, MacMillan R, Jones K, Bowles K, Dowding D, Lee T, Moorhead T, Rodriguez S, Breese E. The Future of Home Health Care: A Strategic Framework for Optimizing Value. Home Health Care Manag Pract. 2016 Nov;28(4):262-278. doi: 10.1177/1084822316666368. Epub 2016 Oct 5.

  PMID: 27746670 BACKGROUND

• Vespa J. (March 13, 2018). The graying of America: More older adults than kids by 2035. United States Census Bureau. Retrieved from https://www.census.gov/library/stories/2018/03/graying-america.html.

  BACKGROUND

• Centers for Medicare & Medicaid Services. (February 06, 2019). New app displays what original Medicare covers. Retrieved from https://www.cms.gov/newsroom/press-releases/new-app-displays-what-original-medicare-covers#:~:text=The%20Medicare%20population%20is%20projected,almost%20daily%20(65%20percent).

  BACKGROUND

• Yao NA, Rose K, LeBaron V, Camacho F, Boling P. Increasing Role of Nurse Practitioners in House Call Programs. J Am Geriatr Soc. 2017 Apr;65(4):847-852. doi: 10.1111/jgs.14698. Epub 2016 Dec 28.

  PMID: 28029709 BACKGROUND

• Keenan TA. (November 2010). Home and community preferences of the 45+ population. AARP Research. Retrieved from http://www.aarp.org/research/topics/community/info-2014/home-community-services-10.html.

  BACKGROUND

• Ng T, Harrington C, Musumeci M, Reaves EL. (November 3, 2015). Medicaid home and community-based services programs: 2012 data update. Kaiser Family Foundation. https://www.kff.org/medicaid/report/medicaid-home-and-community-based-services-programs-2012-data-update/.

  BACKGROUND

• Prasad S, Dunn W, Hillier LM, McAiney CA, Warren R, Rutherford P. Rural geriatric glue: a nurse practitioner-led model of care for enhancing primary care for frail older adults within an ecosystem approach. J Am Geriatr Soc. 2014 Sep;62(9):1772-80. doi: 10.1111/jgs.12982.

  PMID: 25243682 BACKGROUND

• Jaffe S. Home Health Care Providers Struggle With State Laws And Medicare Rules As Demand Rises. Health Aff (Millwood). 2019 Jun;38(6):981-986. doi: 10.1377/hlthaff.2019.00529. No abstract available.

  PMID: 31158027 BACKGROUND

• Maryland Health Care Commission. Home Health Utilization Tables and Agency Data Collection. Table 13: Total Number of Clients (Unduplicated Count) by Jurisdiction of Residence, Payment Source and Agency, Fiscal Year 2008. 2020 [cited 2021 November 19]. Available from https://mhcc.maryland.gov/public_use_files/index.aspx.

  BACKGROUND

• Maryland Health Care Commission. Home Health Utilization Tables and Agency Data Collection. Table 13: Total Number of Clients (Unduplicated Count) by Jurisdiction of Residence, Payment Source and Agency, Fiscal Year 2018. 2020 [cited 2021 November 19]. Available from https://mhcc.maryland.gov/public_use_files/index.aspx.

  BACKGROUND

• Osakwe ZT, Aliyu S, Sosina OA, Poghosyan L. The outcomes of nurse practitioner (NP)-Provided home visits: A systematic review. Geriatr Nurs. 2020 Nov-Dec;41(6):962-969. doi: 10.1016/j.gerinurse.2020.07.001. Epub 2020 Jul 24.

  PMID: 32718756 BACKGROUND

• Wolff-Baker D, Ordona RB. The Expanding Role of Nurse Practitioners in Home-Based Primary Care: Opportunities and Challenges. J Gerontol Nurs. 2019 Jun 1;45(6):9-14. doi: 10.3928/00989134-20190422-01.

  PMID: 31135933 BACKGROUND

• Echeverry LM, Lamb KV, Miller J. Impact of APN Home Visits in Reducing Healthcare Costs and Improving Function in Homebound Heart Failure. Home Healthc Now. 2015 Nov-Dec;33(10):532-7. doi: 10.1097/NHH.0000000000000304.

  PMID: 26529444 BACKGROUND

• Coppa D, Winchester SB, Roberts MB. Home-based nurse practitioners demonstrate reductions in rehospitalizations and emergency department visits in a clinically complex patient population through an academic-clinical partnership. J Am Assoc Nurse Pract. 2018 Jun;30(6):335-343. doi: 10.1097/JXX.0000000000000060.

  PMID: 29878967 BACKGROUND

• Smits M, Peters Y, Ranke S, Plat E, Laurant M, Giesen P. Substitution of general practitioners by nurse practitioners in out-of-hours primary care home visits: A quasi-experimental study. Int J Nurs Stud. 2020 Apr;104:103445. doi: 10.1016/j.ijnurstu.2019.103445. Epub 2019 Sep 28.

  PMID: 32105972 BACKGROUND

• Medicare.gov. (n.d.). Home health services. Retrieved from https://www.medicare.gov/coverage/home-health-services.

  BACKGROUND

• Dobson DaVanzo & Associates. (2014, March 25). Updated report: Impact of proposed legislation H.R. 2504/S. 1332 on Medicare expenditures [memorandum]. Retrieved from http://www.nahc.org/assets/1/7/Dobson_DaVanzo_Impact_Memo_Revised_3_25_14.pdf.

  BACKGROUND

• US Congress. (2019). S.296-Home Health Care Planning Improvement Act of 2019. Retrieved from https://www.congress.gov/bill/116th-congress/senate-bill/296.

  BACKGROUND

• Mora K, Dorrejo XM, Carreon KM, Butt S. Nurse practitioner-led transitional care interventions: An integrative review. J Am Assoc Nurse Pract. 2017 Dec;29(12):773-790. doi: 10.1002/2327-6924.12509. Epub 2017 Aug 28.

  PMID: 28845555 BACKGROUND

MeSH Terms

Conditions

Dementia; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Haera Han, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 7, 2022
• Study Start: June 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)