A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
1 other identifier
interventional
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
September 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 30, 2015
March 1, 2015
5.9 years
September 25, 2014
March 26, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of hospitalizations
From randomization for up to 2 years
Number of outpatient visits to medical doctor
From randomization for up to 2 years
Secondary Outcomes (3)
Mortality
From randomization for up to 2 years
Length of hospital stays
From randomization for up to 2 years
Total health care cost
From randomization for up to 2 years
Study Arms (2)
Disease-Management intervention
EXPERIMENTALBehavioral: 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
No Intervention: Control arm
NO INTERVENTIONControl group not receiving any in
Interventions
The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Deceased
- In a moribund state
- Significant cognitive loss and therefore cannot provide consent
- Psychosis diagnosis
- Severe hearing impairment
- Language difficulties
- Participants in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Health Navigatorlead
- Region Stockholmcollaborator
- Ostergotland County Council, Swedencollaborator
- Vastra Gotaland Regioncollaborator
- Uppsala County Council, Swedencollaborator
Study Sites (1)
Stockholms Läns Landsting
Stockholm, Sweden
Related Publications (1)
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.
PMID: 22960802RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Gustaf Edgren
gustaf@pheph.se
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2014
First Posted
September 29, 2014
Study Start
January 1, 2010
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
March 30, 2015
Record last verified: 2015-03