Heart FailureNCT00533013
Comprehensive Heart Failure Disease Management Community Program
A study testing Disease Management and Tele-Monitoring in people with Heart Failure, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Disease Management and Tele-Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with NYHA-Stage III-IV heart failure recruited in the community;
- Adult patients with NYHA-Stage II-IV heart failure recruited after hospital admission for decompensated heart failure
Who cannot join
- Other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; Severe cognitive impairment; People unconnected to telephone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Program for Disease Management in Heart Failure Patients in the Community
The purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.
Read the detailed description
Heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. Disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. Such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. Designated heart failure clinics were also employed in care given to these patients.
- Conditions
- Heart Failure
- Being tested
- Usual Care, Disease Management and Tele-Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Management of heart failure is provided by primary practitioners and consultant cardiologists
Disease Management and Tele-MonitoringOther
Management of heart failure is provided by cardiologists at regional heart failure clinics and by nurse practitioners at regional heart failure clinics and a designated call center. Decisions on treatment are guided by designated protocols and information derived for tele-monitoring of blood pressure, body weight and pulse rate.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Management of heart failure is provided by primary practitioners and consultant cardiologists Receives: Other: Usual Care |
| Disease Management | Experimental | Disease management led by nurse specialists in regional Heart Failure Clinics and a national Call Center. Tele-Monitoring of body weight, pulse rate and blood pressure is performed at participants' homes. Receives: Other: Disease Management and Tele-Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital admissions for heart failure or all-cause mortality
Measured: 5 years
Secondary outcomes (2)
Health-related Quality of Life;
SF-36 score
Measured: 5 years
Functional status
6-minute walk-test; NYHA classification category
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ofra Kalter-Leibovici MD, Maccabi Healthcare Services, Israel
- Investigators
- Haim Silber, M.D., Principal investigator, Maccabi Healthcare Services, IsraelOfra Kalter-Leibovici, M.D., Principal investigator, Sheba Medical CenterGalit Kaufman, RN, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533013
- Sponsor's protocol ID
- SHEBA-07-4807-OK-CTIL
- Status last verified
- Apr 2019
- First submitted
- 20 Sep 2007
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalter-Leibovici O, Freimark D, Freedman LS, Kaufman G, Ziv A, Murad H, Benderly M, Silverman BG, Friedman N, Cukierman-Yaffe T, Asher E, Grupper A, Goldman D, Amitai M, Matetzky S, Shani M, Silber H; Israel Heart Failure Disease Management Study (IHF-DMS) investigators. Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial. BMC Med. 2017 May 1;15(1):90. doi: 10.1186/s12916-017-0855-z.
PubMed 28457231Kalter-Leibovici O, Murad H, Ziv A, Keidan T, Orion A, Afel Y, Gilutz H, Freimark D, Klibansky-Marom R, Freedman L, Silber H. Causes and predictors of recurrent unplanned hospital admissions in heart failure patients: a cohort study. Intern Emerg Med. 2024 Nov;19(8):2213-2221. doi: 10.1007/s11739-024-03740-2. Epub 2024 Aug 18.
PubMed 39154298
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Program for Disease Management in Heart Failure Patients in the Community
- ClinicalTrials.gov ID
- NCT00533013
- Acronym / sponsor ID
- SHEBA-07-4807-OK-CTIL
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Sep 2007 (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 purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.
Detailed description
Heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. Disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. Such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. Designated heart failure clinics were also employed in care given to these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual CareManagement of heart failure is provided by primary practitioners and consultant cardiologists |
| Disease Management | Experimental | Other: Disease Management and Tele-MonitoringDisease management led by nurse specialists in regional Heart Failure Clinics and a national Call Center. Tele-Monitoring of body weight, pulse rate and blood pressure is performed at participants' homes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with NYHA-Stage III-IV heart failure recruited in the community;
- Adult patients with NYHA-Stage II-IV heart failure recruited after hospital admission for decompensated heart failure
Key exclusion criteria (1 listed)
- Other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; Severe cognitive impairment; People unconnected to telephone
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 |
|---|---|---|
| Usual CareManagement of heart failure is provided by primary practitioners and consultant cardiologists | Other | Usual care |
| Disease Management and Tele-MonitoringManagement of heart failure is provided by cardiologists at regional heart failure clinics and by nurse practitioners at regional heart failure clinics and a designated call center. Decisions on treatment are guided by designated protocols and information derived for tele-monitoring of blood pressure, body weight and pulse rate. | Other | Disease Management |
Primary outcome
hospital admissions for heart failure or all-cause mortality
Time frame: 5 years
2 secondary outcomes
Health-related Quality of Life;
Time frame: 5 years
Functional status
Time frame: 5 years
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 5 Apr 2019.
- Results publication: PubMed 28457231Kalter-Leibovici O, Freimark D, Freedman LS, Kaufman G, Ziv A, Murad H, Benderly M, Silverman BG, Friedman N, Cukierman-Yaffe T, Asher E, Grupper A, Goldman D, Amitai M, Matetzky S, Shani M, Silber H; Israel Heart Failure Disease Management Study (IHF-DMS) investigators. Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial. BMC Med. 2017 May 1;15(1):90. doi: 10.1186/s12916-017-0855-z.
- Derived from this study: PubMed 39154298Kalter-Leibovici O, Murad H, Ziv A, Keidan T, Orion A, Afel Y, Gilutz H, Freimark D, Klibansky-Marom R, Freedman L, Silber H. Causes and predictors of recurrent unplanned hospital admissions in heart failure patients: a cohort study. Intern Emerg Med. 2024 Nov;19(8):2213-2221. doi: 10.1007/s11739-024-03740-2. Epub 2024 Aug 18.
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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.
Haim Silber, M.D. principal investigator
Maccabi Healthcare Services, Israel
Ofra Kalter-Leibovici, M.D. principal investigator
Sheba Medical Center
Galit Kaufman, RN study director
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease Management and Tele-Monitoring in people with Heart Failure, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 1 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 5 Apr 2019. 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 Israel. 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.
What does the primary outcome measure?
hospital admissions for heart failure or all-cause mortality (time frame: 5 years). 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 NCT00533013, which also lists 2 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 5 Apr 2019.