Heart FailureNCT00057200
Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure
A study testing Telephone, videophone care in people with Heart Failure and Telemedicine, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Telemedicine
- What is being tested?
- Telephone, videophone care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the Iowa City VA Medical Center for treatment of congestive heart failure exacerbation. Must be cognitively intact and have a telephone line in the home.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
About this study
Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Home-based intervention programs have reduced unplanned readmission rates for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it is now possible to provide greatly improved access and availability of services in a more timely and cost effective manner directly to patients� homes. Although telehealth offers a number of theoretical advantages, few empirical studies have compared telehealth to traditional delivery modes, and virtually no studies have compared the effectiveness of alternative telehealth applications.
Read the detailed description
Background:
Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Home-based intervention programs have reduced unplanned readmission rates for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it is now possible to provide greatly improved access and availability of services in a more timely and cost effective manner directly to patients� homes. Although telehealth offers a number of theoretical advantages, few empirical studies have compared telehealth to traditional delivery modes, and virtually no studies have compared the effectiveness of alternative telehealth applications.
Objectives:
The purpose of this study is to compare the effectiveness and resource use of two telehealth interventions to traditional care provided for recently discharged outpatients with CHF. Four hypotheses will be tested. Compared to subjects who receive usual care, subjects who receive telehealth interventions (telephone or interactive video) following discharge will: 1) have lower readmission rates; 2) report improved quality of life, self-efficacy, and satisfaction with care; 3) use fewer resources, including hospital days, urgent care visits, and telephone calls; and 4) have higher survival rates.
Methods:
The study is a randomized controlled clinical trial. We will compare usual care to an intervention delivered by either telephone or interactive video to veterans following discharge from the hospital. A total of 198 subjects will be enrolled over three years. Subjects in the treatment groups (telephone or interactive video) will receive the intervention for 90 days following discharge from the hospital. Data to be collected includes measures of quality of life, self-efficacy, satisfaction, resource use, and mortality.
Status:
Project work is ongoing.
- Conditions
- Heart Failure, Telemedicine
- Being tested
- Telephone, videophone care
- Keywords
- Home Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone, videophone careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Telephone, videophone care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2003 (estimated)
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bonnie J. Wakefield, PhD RN, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057200
- Sponsor's protocol ID
- NRI 99-345
- Status last verified
- Feb 2007
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wakefield BJ, Orris LJ, Holman JE, Russell CL. User perceptions of in-home medication dispensing devices. J Gerontol Nurs. 2008 Jul;34(7):15-25. doi: 10.3928/00989134-20080701-10.
PubMed 18649820Wakefield BJ, Bylund CL, Holman JE, Ray A, Scherubel M, Kienzle MG, Rosenthal GE. Nurse and patient communication profiles in a home-based telehealth intervention for heart failure management. Patient Educ Couns. 2008 May;71(2):285-92. doi: 10.1016/j.pec.2008.01.006. Epub 2008 Mar 11.
PubMed 18337049Wakefield BJ, Ward MM, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Telemed J E Health. 2008 Oct;14(8):753-61. doi: 10.1089/tmj.2007.0131.
PubMed 18954244Wakefield BJ, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Outcomes of a home telehealth intervention for patients with heart failure. J Telemed Telecare. 2009;15(1):46-50. doi: 10.1258/jtt.2008.080701.
PubMed 19139220Darkins A, Ryan P, Kobb R, Foster L, Edmonson E, Wakefield B, Lancaster AE. Care Coordination/Home Telehealth: the systematic implementation of health informatics, home telehealth, and disease management to support the care of veteran patients with chronic conditions. Telemed J E Health. 2008 Dec;14(10):1118-26. doi: 10.1089/tmj.2008.0021.
PubMed 19119835Wakefield BJ, Holman JE, Ray A, Morse J, Kiensie M. Nurse and patient preferences for telehealth home care. Geriatric Times. 2004 Mar 1; V(2):27-30.
Wakefield BJ, Holman JE, Ray A, Morse J, Kienzle MG. Nurse and patient communication via low- and high-bandwidth home telecare systems. J Telemed Telecare. 2004;10(3):156-9. doi: 10.1258/135763304323070805.
PubMed 15165441
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
- Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00057200
- Acronym / sponsor ID
- NRI 99-345
- Conditions
- Heart Failure, Telemedicine
- Keywords
- Home Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Jan 2005 (actual)
- First posted
- 31 Mar 2003 (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.
Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Home-based intervention programs have reduced unplanned readmission rates for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it is now possible to provide greatly improved access and availability of services in a more timely and cost effective manner directly to patients� homes. Although telehealth offers a number of theoretical advantages, few empirical studies have compared telehealth to traditional delivery modes, and virtually no studies have compared the effectiveness of alternative telehealth applications.
Detailed description
Background:
Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Home-based intervention programs have reduced unplanned readmission rates for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it is now possible to provide greatly improved access and availability of services in a more timely and cost effective manner directly to patients� homes. Although telehealth offers a number of theoretical advantages, few empirical studies have compared telehealth to traditional delivery modes, and virtually no studies have compared the effectiveness of alternative telehealth applications.
Objectives:
The purpose of this study is to compare the effectiveness and resource use of two telehealth interventions to traditional care provided for recently discharged outpatients with CHF. Four hypotheses will be tested. Compared to subjects who receive usual care, subjects who receive telehealth interventions (telephone or interactive video) following discharge will: 1) have lower readmission rates; 2) report improved quality of life, self-efficacy, and satisfaction with care; 3) use fewer resources, including hospital days, urgent care visits, and telephone calls; and 4) have higher survival rates.
Methods:
The study is a randomized controlled clinical trial. We will compare usual care to an intervention delivered by either telephone or interactive video to veterans following discharge from the hospital. A total of 198 subjects will be enrolled over three years. Subjects in the treatment groups (telephone or interactive video) will receive the intervention for 90 days following discharge from the hospital. Data to be collected includes measures of quality of life, self-efficacy, satisfaction, resource use, and mortality.
Status:
Project work is ongoing.
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: Telephone, videophone care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the Iowa City VA Medical Center for treatment of congestive heart failure exacerbation. Must be cognitively intact and have a telephone line in the home.
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 |
|---|---|---|
| Telephone, videophone care | 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 18649820Wakefield BJ, Orris LJ, Holman JE, Russell CL. User perceptions of in-home medication dispensing devices. J Gerontol Nurs. 2008 Jul;34(7):15-25. doi: 10.3928/00989134-20080701-10.
- Results publication: PubMed 18337049Wakefield BJ, Bylund CL, Holman JE, Ray A, Scherubel M, Kienzle MG, Rosenthal GE. Nurse and patient communication profiles in a home-based telehealth intervention for heart failure management. Patient Educ Couns. 2008 May;71(2):285-92. doi: 10.1016/j.pec.2008.01.006. Epub 2008 Mar 11.
- Results publication: PubMed 18954244Wakefield BJ, Ward MM, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Telemed J E Health. 2008 Oct;14(8):753-61. doi: 10.1089/tmj.2007.0131.
- Results publication: PubMed 19139220Wakefield BJ, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Outcomes of a home telehealth intervention for patients with heart failure. J Telemed Telecare. 2009;15(1):46-50. doi: 10.1258/jtt.2008.080701.
- Results publication: PubMed 19119835Darkins A, Ryan P, Kobb R, Foster L, Edmonson E, Wakefield B, Lancaster AE. Care Coordination/Home Telehealth: the systematic implementation of health informatics, home telehealth, and disease management to support the care of veteran patients with chronic conditions. Telemed J E Health. 2008 Dec;14(10):1118-26. doi: 10.1089/tmj.2008.0021.
- Results publicationWakefield BJ, Holman JE, Ray A, Morse J, Kiensie M. Nurse and patient preferences for telehealth home care. Geriatric Times. 2004 Mar 1; V(2):27-30.
- Results publication: PubMed 15165441Wakefield BJ, Holman JE, Ray A, Morse J, Kienzle MG. Nurse and patient communication via low- and high-bandwidth home telecare systems. J Telemed Telecare. 2004;10(3):156-9. doi: 10.1258/135763304323070805.
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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.
Bonnie J. Wakefield, PhD RN principal investigator
Iowa City VA Health Care System, Iowa City, IA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone, videophone care in people with Heart Failure and Telemedicine, run by US Department of Veterans Affairs 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 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 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?
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 NCT00057200, which also lists 7 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.