Heart FailureNCT00013026
Trial of a Tailored Message Program to Implement CHF Guidelines
A study testing CHF Self-management Education (Web-based Education) in people with Heart Failure, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- CHF Self-management Education (Web-based Education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2004
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
About this study
Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.
Read the detailed description
Background:
Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.
Objectives:
Patients with CHF consume a significant proportion of healthcare resources, with exacerbations of CHF being the second most common reason for medical admission to VA medical centers. Therefore, the main objective is to understand the impact of a tailored education message program designed for direct use by patients on medical resource use. Other objectives include understanding the tools impact on patient compliance and quality of life.
Methods:
Patients have been randomized to one of two groups: 1) intervention group or the 2) control group. The intervention group receives the tailored education messages program. This program assesses patients� beliefs about compliance with medications, diet, and self-monitoring. Based on identified barriers to compliance, intervention patients receive a tailored educational message to dispel these beliefs and improve compliance. The control group interacts with a generic healthcare website. Patients in both groups are monitored for hospitalization; emergent care visits, compliance with prescribed treatment and quality of life
Status:
Project work is ongoing.
- Conditions
- Heart Failure
- Being tested
- CHF Self-management Education (Web-based Education)
- Keywords
- Congestive Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF Self-management Education (Web-based Education)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: CHF Self-management Education (Web-based Education) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Terrence M. Shaneyfelt, MPH MD, Principal investigator, Birmingham VA Medical Center, Birmingham, ALCatarina I. Kiefe, PhD MD, Principal investigator, Birmingham VA Medical Center, Birmingham, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013026
- Sponsor's protocol ID
- CPI 99-124
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Trial of a Tailored Message Program to Implement CHF Guidelines
- ClinicalTrials.gov ID
- NCT00013026
- Acronym / sponsor ID
- CPI 99-124
- Conditions
- Heart Failure
- Keywords
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Indiana University
- Study completion
- Mar 2004 (actual)
- First posted
- 16 Mar 2001 (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 is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.
Detailed description
Background:
Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.
Objectives:
Patients with CHF consume a significant proportion of healthcare resources, with exacerbations of CHF being the second most common reason for medical admission to VA medical centers. Therefore, the main objective is to understand the impact of a tailored education message program designed for direct use by patients on medical resource use. Other objectives include understanding the tools impact on patient compliance and quality of life.
Methods:
Patients have been randomized to one of two groups: 1) intervention group or the 2) control group. The intervention group receives the tailored education messages program. This program assesses patients� beliefs about compliance with medications, diet, and self-monitoring. Based on identified barriers to compliance, intervention patients receive a tailored educational message to dispel these beliefs and improve compliance. The control group interacts with a generic healthcare website. Patients in both groups are monitored for hospitalization; emergent care visits, compliance with prescribed treatment and quality of life
Status:
Project work is ongoing.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: CHF Self-management Education (Web-based Education) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English.
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 |
|---|---|---|
| CHF Self-management Education (Web-based Education) | Behavioural | 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.
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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.
Terrence M. Shaneyfelt, MPH MD principal investigator
Birmingham VA Medical Center, Birmingham, AL
Catarina I. Kiefe, PhD MD principal investigator
Birmingham VA Medical Center, Birmingham, AL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHF Self-management Education (Web-based Education) in people with Heart Failure, 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?
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.