Heart Failure, CongestivePhase 4NCT00141856
Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study)
A Phase 4 study testing Telephone care in people with Heart Failure, Congestive, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary objective of this telephonic heart failure specific patient education study is to assess the incremental clinical, psycho-social, and functional lifestyle benefits of the Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study) when added to standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Telephone care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2008
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria are designed to enroll a population of VA patients with moderate-severe heart failure who are expected to be reasonably representative of and generalizable to potential candidates for the Health E Heart Disease Management Program intervention. To be eligible for the study, veteran beneficiaries must:
- Be 18 years of age
- Have a diagnosis of heart failure
- Have received care in urgent care or have been hospitalized, or have more than 12 outpatient visits in the last twelve months.
- Speak either English or Spanish.
Who cannot join
- Exclusion criteria are designed to exclude persons who are unable to participate in the intervention, whose mortality or health care utilization are driven by co-morbid conditions, or who are enrolled in other research.
- End-stage renal disease on chronic dialysis
- Prior heart transplant
- End-stage or terminal illness in addition to heart failure, such as metastatic malignancy or AIDS with anticipated life expectancy less than 6 months.
- Residence in a nursing home
- Currently participating in another research or care management program.
- No access to a telephone
- Severe dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
VA South Texas Health Care System
San Antonio, Texas, 78229-5700
About this study
The primary objective of this telephonic heart failure specific patient education study is to assess the incremental clinical, psycho-social, and functional lifestyle benefits of the Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study) when added to standard care among veteran beneficiaries with a heart failure diagnosis. A secondary objective is to assess the impact of the Health E Heart Study on total system utilization costs.
Read the detailed description
CHF is one of the most common diagnoses for Department of Veterans Affairs (VA) patients. Cost of care, particularly inpatient hospitalization, is high dollar expenditure in the budget.
Study subjects, recruited from the enrolled patient population of the STVHCS, are identified by a diagnosis of CHF in VA clinical databases. Administrative and clinical inclusion and exclusion criteria will be applied by review of medical records. Subjects who appear to meet inclusion criteria will be mailed a pre-enrollment letter containing an Information Sheet describing the program. A follow-up phone call by an RN will go over the program in detail, review the Information Sheet, and initiate enrollment if the subject wishes to participate. As a less than minimal risk study, verbal consent or refusal will be documented in the respective subject's computerized medical record. Assenting subjects will be randomized by the last digit of the social security (odd and even) in a 1:1 ratio to the control group (standard care at STVHCS) or the intervention group (receiving the telephonic disease management services in addition to standard care). The intervention group will receive a telephonic intervention for one year that consists of formal scheduled nurse telephone education sessions, 24-hour access to a nurse counseling and symptom advice telephone line, printed action plans, workbooks, and individualized assessment letters, medication compliance reminders, vaccination reminders, and physician alerts about signs and symptoms of decompensation. Once enrolled, the RN conducts a telephonic assessment at intake, 6, and 12 months to assess each participant's knowledge, behavior, and health status related to the HF condition.
All subjects enrolled in the study will continue to receive comprehensive heart failure care from the STVHCS with those subjects randomized to the program receiving the additional telephonic intervention. Risk stratification is determined from a combination of review of the medical record patient admission history, and other self-reported information. Factors considered include: Goldman Specific Activity Scale, self-management practices, medical history, medical management, and psychosocial factors. The algorithm employs Boolean logic and sorts patients into one of three categories that determines the frequency of scheduled calls over the course of the year. The communications to physicians occurs through the VA CPRS system regularly, usually after each scheduled patient call. Pre-specific clinical, process, and economic outcomes will be collected on all subjects and analyzed at 6 and 12 months post-randomization.
Comparisons: The study will compare resources consumed in providing care to patients with heart failure post-randomization receiving standard care with resources consumed with standard care supplemented by the Health E Heart Disease Management Program. The study will measure direct VA medical care costs.
Study subjects will all receive comprehensive medical care for congestive heart failure from the STVHCS. Experimental subjects will receive additional telephone calls, patient education sessions, customized treatment and self-management plans, and written patient education materials. All subjects will receive telephonic assessments of health status, and functional status at 6 and 12 months after randomization.
- Conditions
- Heart Failure, Congestive
- Being tested
- Telephone care
- Keywords
- Dis Management, Heart Decompensation, Hearts, Veteran (M01.930)
- 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 careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Behavioral: Telephone care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death/re-hospitalization within 6 to12 months from enrollment; 6 to 12 month all-cause mortality/re-hospitalization treatment failure; 6-month heart failure mortality/re-hospitalization; interim analyses
Measured: At 6 months and at 12 months
Secondary outcomes (2)
all measures at 6-month intervals
Secondary outcomes include alternative definitions of clinical impact through chart review at study start; functional status and resource utilization and costs at study start, at 6 months, and at twelve months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Richard L Bauer, MD MSc BA, Principal investigator, VA South Texas Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141856
- Sponsor's protocol ID
- 045-0023-313
- Other IDs
- Bauer0004
- Status last verified
- Jun 2008
- First submitted
- 30 Aug 2005
- Last updated
- 23 Jun 2008
- Results posted
- No
Publications
Goff DC Jr, Pandey DK, Chan FA, Ortiz C, Nichaman MZ. Congestive heart failure in the United States: is there more than meets the I(CD code)? The Corpus Christi Heart Project. Arch Intern Med. 2000 Jan 24;160(2):197-202. doi: 10.1001/archinte.160.2.197.
PubMed 10647758Berg GD, Wadhwa S, Johnson AE. A matched-cohort study of health services utilization and financial outcomes for a heart failure disease-management program in elderly patients. J Am Geriatr Soc. 2004 Oct;52(10):1655-61. doi: 10.1111/j.1532-5415.2004.52457.x.
PubMed 15450041Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, Freeman GL. Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure. Circulation. 2004 Dec 7;110(23):3518-26. doi: 10.1161/01.CIR.0000148957.62328.89. Epub 2004 Nov 7.
PubMed 15531765Fonarow GC. Heart failure disease management programs: not a class effect. Circulation. 2004 Dec 7;110(23):3506-8. doi: 10.1161/01.CIR.0000151101.17629.20. No abstract available.
PubMed 15583088Mendez GF, Cowie MR. The epidemiological features of heart failure in developing countries: a review of the literature. Int J Cardiol. 2001 Sep-Oct;80(2-3):213-9. doi: 10.1016/s0167-5273(01)00497-1.
PubMed 11578717McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD; Resource Utilization Among Congestive Heart Failure (REACH) Study. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002 Jan 2;39(1):60-9. doi: 10.1016/s0735-1097(01)01700-4.
PubMed 11755288
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study)
- ClinicalTrials.gov ID
- NCT00141856
- Acronym / sponsor ID
- 045-0023-313
- Conditions
- Heart Failure, Congestive
- Keywords
- Dis Management, Heart Decompensation, Hearts, Veteran (M01.930)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Sep 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.
The primary objective of this telephonic heart failure specific patient education study is to assess the incremental clinical, psycho-social, and functional lifestyle benefits of the Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study) when added to standard care among veteran beneficiaries with a heart failure diagnosis. A secondary objective is to assess the impact of the Health E Heart Study on total system utilization costs.
Detailed description
CHF is one of the most common diagnoses for Department of Veterans Affairs (VA) patients. Cost of care, particularly inpatient hospitalization, is high dollar expenditure in the budget.
Study subjects, recruited from the enrolled patient population of the STVHCS, are identified by a diagnosis of CHF in VA clinical databases. Administrative and clinical inclusion and exclusion criteria will be applied by review of medical records. Subjects who appear to meet inclusion criteria will be mailed a pre-enrollment letter containing an Information Sheet describing the program. A follow-up phone call by an RN will go over the program in detail, review the Information Sheet, and initiate enrollment if the subject wishes to participate. As a less than minimal risk study, verbal consent or refusal will be documented in the respective subject's computerized medical record. Assenting subjects will be randomized by the last digit of the social security (odd and even) in a 1:1 ratio to the control group (standard care at STVHCS) or the intervention group (receiving the telephonic disease management services in addition to standard care). The intervention group will receive a telephonic intervention for one year that consists of formal scheduled nurse telephone education sessions, 24-hour access to a nurse counseling and symptom advice telephone line, printed action plans, workbooks, and individualized assessment letters, medication compliance reminders, vaccination reminders, and physician alerts about signs and symptoms of decompensation. Once enrolled, the RN conducts a telephonic assessment at intake, 6, and 12 months to assess each participant's knowledge, behavior, and health status related to the HF condition.
All subjects enrolled in the study will continue to receive comprehensive heart failure care from the STVHCS with those subjects randomized to the program receiving the additional telephonic intervention. Risk stratification is determined from a combination of review of the medical record patient admission history, and other self-reported information. Factors considered include: Goldman Specific Activity Scale, self-management practices, medical history, medical management, and psychosocial factors. The algorithm employs Boolean logic and sorts patients into one of three categories that determines the frequency of scheduled calls over the course of the year. The communications to physicians occurs through the VA CPRS system regularly, usually after each scheduled patient call. Pre-specific clinical, process, and economic outcomes will be collected on all subjects and analyzed at 6 and 12 months post-randomization.
Comparisons: The study will compare resources consumed in providing care to patients with heart failure post-randomization receiving standard care with resources consumed with standard care supplemented by the Health E Heart Disease Management Program. The study will measure direct VA medical care costs.
Study subjects will all receive comprehensive medical care for congestive heart failure from the STVHCS. Experimental subjects will receive additional telephone calls, patient education sessions, customized treatment and self-management plans, and written patient education materials. All subjects will receive telephonic assessments of health status, and functional status at 6 and 12 months after randomization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Telephone care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inclusion criteria are designed to enroll a population of VA patients with moderate-severe heart failure who are expected to be reasonably representative of and generalizable to potential candidates for the Health E Heart Disease Management Program intervention. To be eligible for the study, veteran beneficiaries must:
- Be 18 years of age
- Have a diagnosis of heart failure
- Have received care in urgent care or have been hospitalized, or have more than 12 outpatient visits in the last twelve months.
- Speak either English or Spanish.
Key exclusion criteria (8 listed)
- Exclusion criteria are designed to exclude persons who are unable to participate in the intervention, whose mortality or health care utilization are driven by co-morbid conditions, or who are enrolled in other research.
- End-stage renal disease on chronic dialysis
- Prior heart transplant
- End-stage or terminal illness in addition to heart failure, such as metastatic malignancy or AIDS with anticipated life expectancy less than 6 months.
- Residence in a nursing home
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 care | Behavioural | 1 |
Primary outcome
Cardiovascular death/re-hospitalization within 6 to12 months from enrollment; 6 to 12 month all-cause mortality/re-hospitalization treatment failure; 6-month heart failure mortality/re-hospitalization; interim analyses
Time frame: At 6 months and at 12 months
2 secondary outcomes
all measures at 6-month intervals
Secondary outcomes include alternative definitions of clinical impact through chart review at study start; functional status and resource utilization and costs at study start, at 6 months, and at twelve months.
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 23 Jun 2008.
- Results publication: PubMed 10647758Goff DC Jr, Pandey DK, Chan FA, Ortiz C, Nichaman MZ. Congestive heart failure in the United States: is there more than meets the I(CD code)? The Corpus Christi Heart Project. Arch Intern Med. 2000 Jan 24;160(2):197-202. doi: 10.1001/archinte.160.2.197.
- Results publication: PubMed 15450041Berg GD, Wadhwa S, Johnson AE. A matched-cohort study of health services utilization and financial outcomes for a heart failure disease-management program in elderly patients. J Am Geriatr Soc. 2004 Oct;52(10):1655-61. doi: 10.1111/j.1532-5415.2004.52457.x.
- Results publication: PubMed 15531765Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, Freeman GL. Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure. Circulation. 2004 Dec 7;110(23):3518-26. doi: 10.1161/01.CIR.0000148957.62328.89. Epub 2004 Nov 7.
- Results publication: PubMed 15583088Fonarow GC. Heart failure disease management programs: not a class effect. Circulation. 2004 Dec 7;110(23):3506-8. doi: 10.1161/01.CIR.0000151101.17629.20. No abstract available.
- Results publication: PubMed 11578717Mendez GF, Cowie MR. The epidemiological features of heart failure in developing countries: a review of the literature. Int J Cardiol. 2001 Sep-Oct;80(2-3):213-9. doi: 10.1016/s0167-5273(01)00497-1.
- Results publication: PubMed 11755288McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD; Resource Utilization Among Congestive Heart Failure (REACH) Study. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002 Jan 2;39(1):60-9. doi: 10.1016/s0735-1097(01)01700-4.
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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.
Richard L Bauer, MD MSc BA principal investigator
VA South Texas Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telephone care in people with Heart Failure, Congestive, 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 5 inclusion and 8 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 23 Jun 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Cardiovascular death/re-hospitalization within 6 to12 months from enrollment; 6 to 12 month all-cause mortality/re-hospitalization treatment failure; 6-month heart failure mortality/re-hospitalization; interim analyses (time frame: At 6 months and at 12 months). 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 NCT00141856, which also lists 6 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 23 Jun 2008.