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

October 13, 2025 updated by: Johns Hopkins University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Visiting Nurse Service of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
20-week follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah L. Szanton, PhD, RN, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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