CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition

NCT04460742 | Completed Results

• 3 other identifiers: STUDY000045195K23AG058757-023 K 23 AG058757-02S1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home intervention over 3-4 months. This intervention is designed to help with the transition of care from a hospital or post-acute care facility discharge as well as to optimize functioning and home safety. This clinical study plans to recruit a total of 60 older adults with and without dementia admitted to a home health agency following discharge from a hospital or post-acute care facility. Given that this is a feasibility study, it is not designed or powered to test hypotheses.

Conditions

Care Transitions; Dementia

Keywords

Post-acute care; Home health agency

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Screened as Eligible

  The study will monitor how many older adults are screened and satisfy the eligibility criteria.

  For each potential participant, this outcome is determined prior to possible study enrollment.

• Percentage of Screened Participants That Enroll

  The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.

  This outcome is determined at the time of study enrollment.

• Percentage of Enrolled Participants That Are Retained

  The study will monitor the percentage of participants that complete the study.

  6 months

• Percentage of Participants Who Perceive a Benefit From the Intervention

  Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.

  3 months

• Percentage of Participants Who Perceive a Benefit From the Intervention

  Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.

  6 months

• Proportion of Critical Tasks Completed

  The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.

  Throughout Study Intervention, an average of 5 months

• Data Completeness on Clinical Outcomes

  The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.

  3 months

• Data Completeness on Clinical Outcomes

  The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.

  6 months

Secondary Outcomes (8)

• Home Time in Days (From the Baseline to 3 Month Period)

  Baseline to Month 3 (3 months)

• Home Time in Days (From the 3 to 6 Month Period)

  Month 3 to Month 6 (3 months)

• Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)

  3 months

• Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)

  6 months

• Health Services Use, Percentage

  Baseline to Month 3 (3 months)

Study Arms (2)

CAPABLE Transitions

EXPERIMENTAL

Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.

Behavioral: CAPABLE Transitions; Behavioral: Home Health Agency Care

Care As Usual

ACTIVE COMPARATOR

Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.

Behavioral: Home Health Agency Care

Interventions

CAPABLE Transitions BEHAVIORAL

The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (\<6 visits), registered nurse (\<5 visits), and handyman (\<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.

CAPABLE Transitions

Home Health Agency Care BEHAVIORAL

Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.

CAPABLE Transitions; Care As Usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• admitted to Medicare-certified home health agency following discharge from a hospital, inpatient rehabilitation facility, or skilled nursing facility
• live in Rochester, NY region
• aged 65 years or older
• English-speaking

You may not qualify if:

• plan to move within one year
• has a terminal diagnosis (e.g., \< 1-year life expectancy, in hospice)
• receiving active cancer treatment (active treatment includes surgery or a course of radiation or chemotherapy; it does not include long-term maintenance treatment such as daily hormonal treatment of prostate cancer)
• inability or unwillingness of individual or legal guardian/representative to give written informed consent or assent
• has been discharged from a hospital or post-acute care facility for more than 28 days
• are COVID-19 positive, have suspected COVID-19 infection, or resides with a person who is COVID-19 positive or has suspected COVID-19

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Home Care Agencies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Adam Simning
• Organization: University of Rochester

adam_simning@urmc.rochester.edu

585-474-9534

Study Officials

• Adam Simning, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: March 18, 2021
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)