Congestive Heart FailurePhase 2NCT00105846
An Evaluation of Home-Based Telemedicine Services
A Phase 2 study testing Home care telemedicine in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes
- What is being tested?
- Home care telemedicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Jun 2004
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Nebraska, 46202-2884
About this study
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Read the detailed description
Background:
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Objectives:
The primary objectives were to determine if tele-home health care patients, compared with patients receiving usual home care, have:1) higher levels of health related quality of life and home care satisfaction; 2) fewer inpatient admissions, hospital stays, and outpatient and emergency room visits; and 3) higher levels of home care access, in terms of the total number of contacts between HBPC nurses and patients.
Methods:
Patients were randomly assigned to the intervention or to the control group. Video tele-health units were installed in patient homes for the intervention group, and control group patients received usual home care services. Baseline and six month follow up surveys included questions on perceived health related quality of life and home care satisfaction. T-tests were used to compare intervention and control group members in terms of six month changes in health related quality of life and satisfaction with home care. Multivariate analyses were used to assess group differences in six month health care service use, with prior service use and survival included as covariates.
Status:
The study is completed, with a final enrollment of 37 patients. Three study manuscrip[ts have been completed (two published and one under review).
- Being tested
- Home care telemedicine
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home care telemedicineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Home care telemedicine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2005 (estimated)
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Faith P. Hopp, PhD MA MSW, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105846
- Sponsor's protocol ID
- TEL 20-015
- Status last verified
- Feb 2007
- First submitted
- 17 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D, Lowery J. Outcomes associated with a home care telehealth intervention. Telemed J E Health. 2006 Jun;12(3):297-307. doi: 10.1089/tmj.2006.12.297.
PubMed 16796497Subramanian U, Hopp F, Lowery J, Woodbridge P, Smith D. Research in home-care telemedicine: challenges in patient recruitment. Telemed J E Health. 2004 Summer;10(2):155-61. doi: 10.1089/tmj.2004.10.155.
PubMed 15319045Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D. Home telehealth's role in diabetes case management. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2005 Apr 1; 11:220.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Home-Based Telemedicine Services
- ClinicalTrials.gov ID
- NCT00105846
- Acronym / sponsor ID
- TEL 20-015
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Jun 2004 (actual)
- First posted
- 18 Mar 2005 (estimated)
- 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.
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Detailed description
Background:
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Objectives:
The primary objectives were to determine if tele-home health care patients, compared with patients receiving usual home care, have:1) higher levels of health related quality of life and home care satisfaction; 2) fewer inpatient admissions, hospital stays, and outpatient and emergency room visits; and 3) higher levels of home care access, in terms of the total number of contacts between HBPC nurses and patients.
Methods:
Patients were randomly assigned to the intervention or to the control group. Video tele-health units were installed in patient homes for the intervention group, and control group patients received usual home care services. Baseline and six month follow up surveys included questions on perceived health related quality of life and home care satisfaction. T-tests were used to compare intervention and control group members in terms of six month changes in health related quality of life and satisfaction with home care. Multivariate analyses were used to assess group differences in six month health care service use, with prior service use and survival included as covariates.
Status:
The study is completed, with a final enrollment of 37 patients. Three study manuscrip[ts have been completed (two published and one under review).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Home care telemedicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Home care telemedicine | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 16796497Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D, Lowery J. Outcomes associated with a home care telehealth intervention. Telemed J E Health. 2006 Jun;12(3):297-307. doi: 10.1089/tmj.2006.12.297.
- Results publication: PubMed 15319045Subramanian U, Hopp F, Lowery J, Woodbridge P, Smith D. Research in home-care telemedicine: challenges in patient recruitment. Telemed J E Health. 2004 Summer;10(2):155-61. doi: 10.1089/tmj.2004.10.155.
- Results publicationHopp F, Woodbridge P, Subramanian U, Copeland L, Smith D. Home telehealth's role in diabetes case management. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2005 Apr 1; 11:220.
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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.
Faith P. Hopp, PhD MA MSW principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Home care telemedicine in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by US Department of Veterans Affairs at 2 sites 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105846, which also lists 3 linked publications.
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 7 Apr 2015.