CAPABLE Intervention for Physical Disabilities

(CAPABLE-VNSNY Trial)

Overseen By Sarah L. Szanton, PhD, RN

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive impairment, Dementia, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called CAPABLE (a therapeutic intervention) can help older adults improve sleep, balance, mobility, and self-care after a hospital stay. The program includes sessions with therapists and nurses, along with potential home modifications for safety. Participants will either receive these services or continue with their usual care without additional intervention. Individuals who are 65 or older, have had a recent hospital stay, and find daily tasks challenging might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative care strategies that could enhance recovery and daily life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CAPABLE intervention is safe for older adults?

Research has shown that the CAPABLE program helps older adults live more independently. It includes visits from an occupational therapist and a nurse, along with modifications to make the home safer. Studies have found that these steps can improve movement and help prevent falls.

Regarding safety, no evidence indicates major risks or side effects. Participants generally handle the program well. The focus is on practical assistance and home safety, which usually involves low risk. The program aims to achieve personal goals, such as safely getting in and out of the bathtub.

Overall, the CAPABLE program appears to be a safe choice for those wanting to improve their daily living skills after a hospital stay. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAPABLE intervention for physical disabilities because it combines personalized care strategies with practical home modifications to enhance daily living. Unlike traditional treatments that might focus solely on medical or therapeutic interventions, CAPABLE uniquely integrates services from occupational therapists, registered nurses, and licensed handymen to address both personal and environmental factors. This holistic approach aims to empower individuals by targeting their self-identified functional goals, such as getting safely into the tub or climbing stairs to sleep in their own bed, which is not typically addressed by standard care options.

What evidence suggests that the CAPABLE intervention is effective for improving physical abilities in older adults?

Research has shown that the CAPABLE program, which participants in this trial may receive, helps older adults reduce disability. In several studies, participants found it easier to perform daily activities like bathing and moving around. All six studies observed these improvements, with some also reporting better mood and less pain. The program involves collaboration with an occupational therapist and a nurse, along with home modifications, to help participants achieve personal goals for better self-care. Overall, evidence supports CAPABLE as an effective method for helping older adults manage disabilities and enhance their quality of life. ^{1 2 6 7 8}

Who Is on the Research Team?

Sarah L. Szanton, PhD, RN

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above who are part of the VNSNY CHOICE Medicare Plan, can stand (with help if needed), and have been out of the hospital for at least 60 days. They must struggle with daily tasks like walking or self-care but cannot be severely cognitively impaired, frequently hospitalized, undergoing cancer treatment, or planning to move within a year.

Inclusion Criteria

I am 65 years old or older.

Are a member of the VNSNY CHOICE Medicare Advantage Health Plan

I can stand up with or without help.

Exclusion Criteria

I have been hospitalized more than 3 times in the last year.

Have plans to relocate in less than one year

Have significant cognitive impairment identified by the Callahan screening tool

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CAPABLE intervention, including up to 10 in-home sessions with an occupational therapist and a nurse, and home modifications

20 weeks

Up to 10 in-home sessions

Follow-up

Participants are monitored for changes in ADL difficulty scores

32 weeks

Reassessments at 20 weeks and possibly at 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAPABLE

Trial Overview The CAPABLE intervention is being tested to see if it helps improve sleep, balance, mobility, and self-care in older adults after they've been discharged from the hospital. It includes medication assistance, muscle and balance exercises, pain management strategies and home modifications.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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).

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

An individualized, goal-directed rehabilitation protocol significantly improved functional outcomes in 32 children with developmental delays over a 3-month period, as measured by various assessment scales.

The study found that while the rehabilitation goals were achieved, improvements in these goals did not directly correlate with changes in overall functional levels, highlighting the importance of caregiver involvement in the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of individualized, goal directed institutional based rehabilitation programme in children with developmental delay disorders, in a region with limited rehabilitation accessibility. Mishra, K., Siddharth, V., Elhence, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4074085/

CAPABLE trial: a randomized controlled trial of nurse ... The primary outcome is decreased disability in self-care (ADL). Secondary outcomes are sustained decrease in self care disability as well as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8169719/

Improvements of disability outcomes in CAPABLE older ... The CAPABLE program reduces disability in low-income older adults. In this study, we used CAPABLE baseline and five-month data to examine whether its ...

3. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17383

CAPABLE program improves disability in multiple randomized ... The CAPABLE program resulted in substantial improvements in ADLs and IADLs in all six trials with other outcomes varying across studies.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0197457222000313

Drivers and restrainers to adoption and spread of evidence ... Evidence from multiple trials and community implementations shows CAPABLE improves participant self-efficacy, reduces disability, improves depression and pain, ...

5. capablenationalcenter.org capablenationalcenter.org/wp-content/uploads/CAPABLESTL_OTJR.pdf

Implementation of the CAPABLE Program With Older ... The study reviews outcomes related to client engagement and retainment, client-directed goals, therapeutic intervention, home modifications, and functional.

6. homesafety.net homesafety.net/wp-content/uploads/2019/04/CAPABLE-Study-results.pdf

HHS Public Access Data on CAPABLE's effects on hospitalization are incomplete. Of those currently enrolled, 37% reported being hospitalized in the year before enrollment in.

7. ncoa.org ncoa.org/article/evidence-based-program-capable/

Evidence-Based Program: CAPABLE CAPABLE is a person-directed home-based program designed to increase mobility, function, and capacity, to allow older adults to age in their home and community.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988477/

A Systematic Review of Home Modifications for Aging in Place ... Results: Among 20 studies, 13 (65%) confirmed the effectiveness of home modifications in fall prevention, functional independence, and cost savings. Seven ...