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

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.

Study Overview

• Status: Recruiting
• Conditions: Disability Physical
• Intervention / Treatment: Other: CAPABLE

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.

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Trachtenberg, BA; Phone Number: 212-760-3112; Email: Melissa.Trachtenberg@vnsny.org
• Study Contact Backup: Name: Sarah L. Szanton, PhD, RN; Phone Number: (410) 502-2605; Email: sszanto1@jhu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • Visiting Nurse Service of New York
      • Contact: Kathryn H Bowles, PhD; Phone Number: 212-609-5640; Email: mailto:Kathryn.Bowles@vnsny.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean ADL Difficulty Score	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	20-week follow-up period

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sarah L. Szanton, PhD, RN, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2018
• Primary Completion (Actual): September 11, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical function; Rehospitalization; Older Adult
• Other Study ID Numbers: IRB00141968; 1R01AG056607-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No