- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04045054
Home-based Transitional Telecare for Older Veterans
Home-based Team Transitional Telecare to Optimize Mobility and Physical Activity in Recently Hospitalized Older Veterans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristin Phillips, PharmD
- Phone Number: 734-845-5564
- Email: kristin.phillips@va.gov
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48105
- Recruiting
- VA Ann Arbor Healthcare System
-
Contact:
- Kristin Phillips, PharmD
- Phone Number: 734-845-5564
- Email: kristin.phillips@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
The Link Team follows up with the participants for 6 months after they discharge from the hospital
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Telemedicine Encounters
Time Frame: 1 year
|
Number of successful telemedicine encounters is measured for each participant.
|
1 year
|
|
Successful Telemedicine Encounter Rate
Time Frame: 1 year
|
Percentage of successful telemedicine encounters is measured for each participant.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
(1) Baseline; (2) Up to 6 months; (3) Up to 1 year.
|
|
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.
|
(1) Baseline; (2) Up to 6 months; (3) Up to 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neil Alexander, MD, VA Ann Arbor Healthcare System
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AWD004365
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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