A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure

Phase 3

• Conditions: The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
• Interventions: Behavioral: Disease-Management intervention

• Registration Number: NCT02251899
• Lead Sponsor: Health Navigator

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-30
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disease-Management intervention	Disease-Management intervention	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of hospital stays	From randomization for up to 2 years
Total health care cost	From randomization for up to 2 years
Mortality	From randomization for up to 2 years

Trial Locations

Locations (1)

Stockholms Läns Landsting; 🇸🇪 Stockholm, Sweden