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

Disability Physical Clinical Trial

— CAPABLE-VNSNY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03456128
• Other study ID #: IRB00141968
• Secondary ID: 1R01AG056607-01
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2018
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Melissa Trachtenberg, BA
• Phone: 212-760-3112
• Email: Melissa.Trachtenberg[@]vnsny.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: September 2024
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Disability Physical

Intervention

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.

Locations

Country	Name	City	State
United States	Visiting Nurse Service of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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