TelemedicineNCT04045054
Home-based Transitional Telecare for Older Veterans
A study testing Link Team in people with Telemedicine and Veterans Health, run by VA Ann Arbor Healthcare System at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Telemedicine, Veterans Health, Physical Activity
- What is being tested?
- Link Team
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Kristin Phillips, PharmD, 734-845-5564, kristin.phillips@va.gov
About this study
Official title: Home-based Team Transitional Telecare to Optimize Mobility and Physical Activity in Recently Hospitalized Older Veterans
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).
Read the 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.
- Conditions
- Telemedicine, Veterans Health, Physical Activity, Mobility
- Being tested
- Link Team
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Link TeamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The Link Team follows up with the participants for 6 months after they discharge from the hospital Receives: Behavioral: Link Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telemedicine Encounters
Number of successful telemedicine encounters is measured for each participant.
Measured: 1 year
Successful Telemedicine Encounter Rate
Percentage of successful telemedicine encounters is measured for each participant.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: (1) Baseline; (2) Up to 6 months; (3) Up to 1 year.
Wearable sensors
Physical activity will be measured over a seven day period with a research grade sensor, the activPAL3VT.
Measured: (1) Baseline; (2) Up to 6 months; (3) Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start29 Sep 2017
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Ann Arbor Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of Michigan, Michigan Health Endowment Fund
- Responsible party
- Principal investigator, Neil Alexander, VA Ann Arbor Healthcare System
- Investigators
- Neil Alexander, MD, Principal investigator, VA Ann Arbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045054
- Sponsor's protocol ID
- AWD004365
- Status last verified
- Jul 2021
- First submitted
- 17 May 2019
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34551725
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Team Transitional Telecare to Optimize Mobility and Physical Activity in Recently Hospitalized Older Veterans
- ClinicalTrials.gov ID
- NCT04045054
- Acronym / sponsor ID
- AWD004365
- Conditions
- Telemedicine, Veterans Health, Physical Activity, Mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Ann Arbor Healthcare SystemUS federal agency
- Collaborators
- University of Michigan, Michigan Health Endowment Fund
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Link TeamThe Link Team follows up with the participants for 6 months after they discharge from the hospital |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Link TeamA 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. | Behavioural | Intervention |
Primary outcome
Telemedicine Encounters
Time frame: 1 year
Number of successful telemedicine encounters is measured for each participant.
Successful Telemedicine Encounter Rate
Time frame: 1 year
Percentage of successful telemedicine encounters is measured for each participant.
2 secondary outcomes
Remote Short Portable Performance Battery (rSPPB)
Time frame: (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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 34551725Alexander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Alexander, MD principal investigator
VA Ann Arbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Link Team in people with Telemedicine and Veterans Health, run by VA Ann Arbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristin Phillips, PharmD (734-845-5564, kristin.phillips@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telemedicine Encounters (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.