Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention (CAPABLE-VNSNY)
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|ClinicalTrials.gov Identifier: NCT03456128|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Disability Physical||Other: CAPABLE||Not Applicable|
Currently, there is no evidence-based approach to improve post-hospitalization functional decline. CAPABLE uses a novel inter-professional team involving an occupational therapist, nurse, and handyman to improve ADLs in older adults post-hospitalization.
In a Center for Medicare & Medicaid Innovation (CMMI) demonstration project, CAPABLE demonstrated a 45% reduction of ADL difficulties in older adults from baseline to five months.The significance of this improvement could make the difference between aging at home independently and relocating to institutional care. While these results are encouraging, CAPABLE needs evaluation in real world health delivery contexts with more ethnic diversity.The purpose of this study is to test the effectiveness of CAPABLE in older adults in an active community health care program.
Interventions: CAPABLE Intervention: Participants in the treatment group will receive up to 10 in-home sessions (≤6 visits with an occupational therapist and ≤4 visits from a nurse)-and up to $1500 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component (education, assessment, and identification of functional goals, specific strategies tailored to goals and based on protocols). Usual Care Group: Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. After baseline, all study participants will be reassessed at 20 weeks and possibly a third interview at 52 weeks. Assessments will be completed by a research assistant masked to treatment condition.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||268 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study is a single-masked, two-group, randomized trial to test the effectiveness of CAPABLE in reducing ADL difficulties compared to those randomized to usual care.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||1: 1. The outcome assessor will be unaware of which groups the older adults are assigned to.|
|Official Title:||Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention|
|Actual Study Start Date :||August 25, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||July 2021|
The experimental group will receive CAPABLE services. These include ≤10 sessions: ≤ 6 with an Occupational Therapist (OT) and ≤ 4 sessions with a Registered Nurse (RN) and up to ≤ $1,500 of home safety and home modifications from a licensed handyman who is guided by the OT. The OT and RN sessions will target participants' self-identified functional goals (e.g., getting safely into the tub, getting upstairs to sleep in own bed).
It involves up to 10 in-home tailored interventions of approximately 60 minutes duration each over a 5-month period. The assessment driven interventions are delivered by an Occupational Therapist (OT) (≤ 6 home visits for ≤ 1hour), a Registered Nurse (RN) (≤ 4 home visits for ≤ 1hour), and a handyman (HM) team.
No Intervention: Usual Care
Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare.
- Mean ADL Difficulty Score [ Time Frame: 20-week follow-up period ]Change in ADL- the range is 0 - 16, with higher scores indicating that the participant needs a lot of help with performing many ADLs (is more disabled) and lower scores indicating that the participant is not disabled
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456128
|Contact: Melissa Trachtenberg, BA||212-760-3112||Melissa.Trachtenberg@vnsny.org|
|Contact: Sarah L. Szanton, PhD, RN||(410) firstname.lastname@example.org|
|United States, New York|
|Visiting Nurse Service of New York||Recruiting|
|New York, New York, United States, 10001|
|Contact: Kathryn H Bowles, PhD 212-609-5640 mailto:Kathryn.Bowles@vnsny.org|
|Principal Investigator:||Sarah L. Szanton, PhD, RN||Johns Hopkins University|