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

268 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the CAPABLE program, which helps older adults after hospitalization by providing home visits from a team of professionals. The goal is to improve their ability to live independently through personalized support and home modifications. The CAPABLE program aims to reduce the impact of disability among low-income older adults by addressing individual capacities and the home environment.

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 data supports the effectiveness of the CAPABLE treatment for physical disabilities?

The CAPABLE program has been shown to improve disability in older adults through multiple randomized trials. It involves a team approach with an occupational therapist, nurse, and handyworker to help individuals achieve their personal goals and improve their living environment, which has been effective in enhancing their capacity and reducing disability. ^{1 2 3 4 5}

How is the CAPABLE treatment different from other treatments for physical disabilities?

The CAPABLE treatment is unique because it combines home-based interventions with a focus on enhancing the individual's ability to perform daily activities, involving a team effort that includes professionals, family, and caregivers, which is not typically emphasized in standard treatments for physical disabilities. ^{6 7 8 9 10}

Research Team

Sarah L. Szanton, PhD, RN

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

CAPABLE program improves disability in multiple randomized trials. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial. [2022]

3. Netherlands 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effect of increased exposure to physiotherapy on skill acquisition of children with cerebral palsy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Uses of evidence in disability outcomes and effectiveness research. [2019]

6. Croatia pubmed.ncbi.nlm.nih.gov

Functional Reeducation in Cognitively Impaired Condition. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Interrater reliability of the capacity profile in children with neurodevelopmental disabilities. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Kindy Moves: the feasibility of an intensive interdisciplinary programme on goal and motor outcomes for preschool-aged children with neurodisabilities requiring daily equipment and physical assistance. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Enhancing participation for children with disabilities: application of the ICF enablement framework to pediatric physical therapist practice. [2011]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Promoting Functional Activity Engagement in People with Multiple Disabilities through the Use of Microswitch-Aided Programs. [2020]