NCT04045054

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

May 17, 2019

Last Update Submit

July 2, 2021

Conditions

TelemedicineVeterans HealthPhysical ActivityMobility

Outcome Measures

Primary Outcomes (2)

  • Telemedicine Encounters

    Number of successful telemedicine encounters is measured for each participant.

    1 year

  • Successful Telemedicine Encounter Rate

    Percentage of successful telemedicine encounters is measured for each participant.

    1 year

Secondary Outcomes (2)

  • Remote Short Portable Performance Battery (rSPPB)

    (1) Baseline; (2) Up to 6 months; (3) Up to 1 year.

  • Wearable sensors

    (1) Baseline; (2) Up to 6 months; (3) Up to 1 year.

Study Arms (1)

Intervention

OTHER

The Link Team follows up with the participants for 6 months after they discharge from the hospital

Behavioral: Link Team

Interventions

Link TeamBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

RECRUITING

Related Publications (1)

  • Alexander NB, Phillips K, Wagner-Felkey J, Chan CL, Hogikyan R, Sciaky A, Cigolle C. Team VA Video Connect (VVC) to optimize mobility and physical activity in post-hospital discharge older veterans: baseline assessment. BMC Geriatr. 2021 Sep 22;21(1):502. doi: 10.1186/s12877-021-02454-w.

    PMID: 34551725DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Neil Alexander, MD

    VA Ann Arbor Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Phillips, PharmD

CONTACT

734-845-5564kristin.phillips@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Ann Arbor Geriatric Research Education and Clinical Center

Study Record Dates

First Submitted

May 17, 2019

First Posted

August 5, 2019

Study Start

September 29, 2017

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)