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Home-based Transitional Telecare for Older Veterans

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ClinicalTrials.gov Identifier: NCT04045054
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
University of Michigan
Michigan Health Endowment Fund
Information provided by (Responsible Party):
Christine Cigolle, VA Ann Arbor Healthcare System

Brief 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).

Condition or disease Intervention/treatment Phase
Telemedicine Veterans Health Physical Activity Mobility Behavioral: Link Team Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Home-based Team Transitional Telecare to Optimize Mobility and Physical Activity in Recently Hospitalized Older Veterans
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Intervention
The Link Team follows up with the participants for 6 months after they discharge from the hospital
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.




Primary Outcome Measures :
  1. Telemedicine Encounters [ Time Frame: 1 year ]
    Number of successful telemedicine encounters is measured for each participant.

  2. Successful Telemedicine Encounter Rate [ Time Frame: 1 year ]
    Percentage of successful telemedicine encounters is measured for each participant.


Secondary Outcome Measures :
  1. Remote Short Portable Performance Battery (rSPPB) [ Time Frame: (1) Baseline; (2) Up to 6 months; (3) Up to 1 year. ]
    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.

  2. Wearable sensors [ Time Frame: (1) Baseline; (2) Up to 6 months; (3) Up to 1 year. ]
    Physical activity will be measured over a seven day period with a research grade sensor, the activPAL3VT.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045054


Contacts
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Contact: Kristin Phillips, PharmD 734-845-5564 kristin.phillips@va.gov

Locations
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United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Kristin Phillips, PharmD    734-845-5564    kristin.phillips@va.gov   
Sponsors and Collaborators
VA Ann Arbor Healthcare System
University of Michigan
Michigan Health Endowment Fund
Investigators
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Principal Investigator: Christine Cigolle, MD VA Ann Arbor Healthcare System

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Responsible Party: Christine Cigolle, Associate Director, Ann Arbor Geriatric Research Education and Clinical Center, VA Ann Arbor Healthcare System
ClinicalTrials.gov Identifier: NCT04045054     History of Changes
Other Study ID Numbers: AWD004365
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No