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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04045054
Other study ID # AWD004365
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2017
Est. completion date September 30, 2022

Study information

Verified date July 2021
Source VA Ann Arbor Healthcare System
Contact Kristin Phillips, PharmD
Phone 734-845-5564
Email kristin.phillips@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The project focuses on supporting home care in the post-hospitalization period (Home Health Phase), and then further optimizing the older Veterans' recovery of mobility and physical activity in the transition back to the home/community (Follow-up Phase).


Description:

Medicare-funded home care bridges gaps in the transition of patients from hospital to home; yet, it is a bridge with gaps of its own, having limited communication with both the discharging hospital physician and the receiving primary care provider and having limited knowledge of the longitudinal medical history of the patient. Once home care is completed, there is often no plan of continued support to transition the older Veteran back to optimal home/community function. In the Home Health Phase, a VA-home care Link Team (physician, clinical pharmacist, social worker, and physical activity trainer) will provide immediate communication/coordination between the VA Ann Arbor Healthcare System (VAAAHS) and home care agencies contracted by VAAAHS. The intervention is based on a conceptual model of home care as a bridge between hospital and home, in which three interconnected domains determine short-term and long-term outcomes: medical complexity (e.g., medication management), social complexity (e.g., caregiving, environment), and functional impairment (e.g., mobility, physical activity). The VA Link Team will provide support and assessment for each domain. The team will use telemedicine technology and wearable sensors in the home to gather patient data and facilitate communication between the patient, health care providers, and the Link Team. The Follow-up Phase begins at the end of formal home care services, when the Link Team will provide patient-centered care in two ways: 1) support for the the Veteran and caregiver in the event of changes in medical condition or medications as well as social or caregiver stressors; and 2) coaching to the Veteran and the caregiver during this transition period to optimize functional mobility and physical activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Under VA Ann Arbor Healthcare System (VAAAHS) primary care practitioner (PCP) oversight. - Recently discharged from inpatient hospitalization. - Received inpatient (pre-discharge) physical therapy evaluation and have identified rehabilitation goals for care to be provided in the home. - Identified caregiver who agrees to participate and who will be the key link if the Veteran is unable to care for himself or has memory problems. Exclusion Criteria: - Require highly specialized equipment or therapy (e.g. rehabilitation for spinal cord injury, prosthesis training following leg amputation). - Have active mental health conditions (e.g. paranoia) that may interfere with program participation. - Require strict bed rest (e.g. long-term extensive wound healing needs) or strict use of a wheelchair.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Link Team
A VA home care Link Team (clinical pharmacist, social worker, physical activity trainer) provides the intervention based on a conceptual model of home care as a bridge between hospital and home, in which three interconnected domains determine short-term and long-term outcomes: medical complexity (e.g., medication management), social complexity (e.g., caregiving, environment), and functional impairment (e.g., mobility, physical activity). The Link Team provides support and assessment for each domain, and will use tablet technology and wearable sensors in the home to gather patient data and facilitate communication. At the end of formal home care services, the Link Team provides patient-centered care in: 1) support for the the Veteran and caregiver in the event of changes in medical condition or medications and social or caregiver stressors; and 2) coaching to the Veteran and the caregiver during this transition period to optimize functional mobility and physical activity.

Locations

Country Name City State
United States VA Ann Arbor Healthcare System Ann Arbor Michigan

Sponsors (3)

Lead Sponsor Collaborator
VA Ann Arbor Healthcare System Michigan Health Endowment Fund, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Telemedicine Encounters Number of successful telemedicine encounters is measured for each participant. 1 year
Primary Successful Telemedicine Encounter Rate Percentage of successful telemedicine encounters is measured for each participant. 1 year
Secondary Remote Short Portable Performance Battery (rSPPB) The rSPPB, based on the widely used SPPB measures of walking speed, multiple chair stands, and standing balance, will be performed with caregiver standby assist while the Veteran is viewed via the tablet camera. (1) Baseline; (2) Up to 6 months; (3) Up to 1 year.
Secondary Wearable sensors Physical activity will be measured over a seven day period with a research grade sensor, the activPAL3VT. (1) Baseline; (2) Up to 6 months; (3) Up to 1 year.
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