NCT03456128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 25, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

5 years

First QC Date

January 3, 2018

Last Update Submit

October 13, 2025

Conditions

Keywords

Older AdultRehospitalizationPhysical function

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

CAPABLEOTHER

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Visiting Nurse Service of New York

New York, New York, 10001, United States

Location

MeSH Terms

Interventions

CAPABLE protocol

Study Officials

  • Sarah L. Szanton, PhD, RN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
1: 1. The outcome assessor will be unaware of which groups the older adults are assigned to.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

March 7, 2018

Study Start

August 25, 2018

Primary Completion

September 11, 2023

Study Completion

September 30, 2025

Last Updated

October 15, 2025

Record last verified: 2025-10

Locations