Back to resultsA Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
Primary Purpose
The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Disease-Management intervention
Sponsored by
About this trial
This is an interventional supportive care trial for The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
Eligibility Criteria
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
Sites / Locations
- Stockholms Läns LandstingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Disease-Management intervention
No Intervention: Control arm
Arm Description
Behavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
Control group not receiving any in
Outcomes
Primary Outcome Measures
Number of hospitalizations
Number of outpatient visits to medical doctor
Secondary Outcome Measures
Mortality
Length of hospital stays
Total health care cost
Full Information
NCT ID
NCT02251899
First Posted
September 25, 2014
Last Updated
March 26, 2015
Sponsor
Health Navigator
Collaborators
Region Stockholm, Ostergotland County Council, Sweden, Vastra Gotaland Region, Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02251899
Brief Title
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
Official Title
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Navigator
Collaborators
Region Stockholm, Ostergotland County Council, Sweden, Vastra Gotaland Region, Uppsala County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Disease-Management intervention
Arm Type
Experimental
Arm Description
Behavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
Arm Title
No Intervention: Control arm
Arm Type
No Intervention
Arm Description
Control group not receiving any in
Intervention Type
Behavioral
Intervention Name(s)
Disease-Management intervention
Intervention Description
The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
Primary Outcome Measure Information:
Title
Number of hospitalizations
Time Frame
From randomization for up to 2 years
Title
Number of outpatient visits to medical doctor
Time Frame
From randomization for up to 2 years
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
From randomization for up to 2 years
Title
Length of hospital stays
Time Frame
From randomization for up to 2 years
Title
Total health care cost
Time Frame
From randomization for up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustaf Edgren
Email
gustaf@pheph.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustaf Edgren
Organizational Affiliation
gustaf@pheph.se
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholms Läns Landsting
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustaf Edgren, MD PhD
Phone
+46708186862
Email
gustaf@pheph.se
12. IPD Sharing Statement
Citations:
PubMed Identifier
22960802
Citation
Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
Results Reference
result
Learn more about this trial
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
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