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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 April 2015 |
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Main ID: |
NCT02251899 |
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Date of registration:
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25/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
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Scientific title:
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A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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10000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02251899 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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Phase 3
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Gustaf Edgren, MD PhD |
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Address:
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Telephone:
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+46708186862 |
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Email:
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gustaf@pheph.se |
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Affiliation:
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Name:
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Gustaf Edgren |
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Address:
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Telephone:
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Email:
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gustaf@pheph.se |
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Affiliation:
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Name:
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Gustaf Edgren |
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Address:
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Telephone:
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Email:
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Affiliation:
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gustaf@pheph.se |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with =1 unplanned inpatient occasion with primary diagnosis of heart failure
( I50) during the last 12 months
- Heart failure grade NYHA II- III
- Accurate heart failure diagnosis
- Living in one of four Swedish counties where the trial is ongoing
Exclusion Criteria:
- Deceased
- In a moribund state
- Significant cognitive loss and therefore cannot provide consent
- Psychosis diagnosis
- Severe hearing impairment
- Language difficulties
- Participants in another study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
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Intervention(s)
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Behavioral: Disease-Management intervention
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Primary Outcome(s)
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Number of hospitalizations
[Time Frame: From randomization for up to 2 years]
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Number of outpatient visits to medical doctor
[Time Frame: From randomization for up to 2 years]
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Secondary Outcome(s)
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Length of hospital stays
[Time Frame: From randomization for up to 2 years]
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Mortality
[Time Frame: From randomization for up to 2 years]
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Total health care cost
[Time Frame: From randomization for up to 2 years]
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Secondary ID(s)
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HN-AHS-HS-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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