Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention (CAPABLE-VNSNY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456128
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study evaluates whether the utilization of integrated health services such as help with medications, muscle strengthening, balance training, pain management and home modification interventions can help improve older adults' ability to sleep, balance, walk, and take care of themselves after hospitalization.

Condition or disease Intervention/treatment Phase
Disability Physical Other: CAPABLE Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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).
Other: CAPABLE
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 65 years old;
  • Are 60 days post-hospitalization in an acute care setting and have had a Visiting Nurse Service of New York (VNSNY) visit;
  • Have difficulty with at least one activity of daily living (ADL);
  • Are a member of the VNSNY CHOICE Medicare Advantage Health Plan;
  • Are able to stand with or without assistance; and
  • Are available during the intervention period

Exclusion Criteria:

  • Have significant cognitive impairment identified by the Callahan screening tool;
  • Do not speak English or Spanish;
  • Have had more than 3 hospitalizations within the past 12 months;
  • Are actively receiving radiation or chemotherapy;
  • Have plans to relocate in less than one year;
  • Have diagnoses of the following: Dementia, Alzheimer's, Other Cerebral Degeneration, and serious cognitive impairment or OASIS assessment level 3 response on M1034 "serious progressive conditions that could lead to death within a year"

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Melissa Trachtenberg, BA 212-760-3112 Melissa.Trachtenberg@vnsny.org
Contact: Sarah L. Szanton, PhD, RN (410) 502-2605 sszanto1@jhu.edu

Locations
Layout table for location information
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   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Sarah L. Szanton, PhD, RN Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03456128     History of Changes
Other Study ID Numbers: IRB00141968
1R01AG056607-01 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Older Adult
Rehospitalization
Physical function