Clinical trial NCT03456128: Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention
Official title: Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Disability Physical
Keywords: Older Adult
Rehospitalization
Physical function
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-03-07
Enrollment: 268
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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"

Primary outcomes:
measure: Mean ADL Difficulty Score
timeFrame: 20-week follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Visiting Nurse Service of New York
state: New York
Study officials:
affiliation: Johns Hopkins University
name: Sarah L. Szanton, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: