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OpenTrials
Completed

NCT Number: NCT03456128

Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visiting Nurse Service of New York

New York, 10001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

CAPABLE

Other

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: CAPABLE-VNSNY

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Mar 7, 2018
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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