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

March 26, 2015 updated by: Health Navigator
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Stockholms Läns Landsting
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
No Intervention: No Intervention: Control arm
Control group not receiving any in

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalizations
Time Frame: From randomization for up to 2 years
From randomization for up to 2 years
Number of outpatient visits to medical doctor
Time Frame: From randomization for up to 2 years
From randomization for up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: From randomization for up to 2 years
From randomization for up to 2 years
Length of hospital stays
Time Frame: From randomization for up to 2 years
From randomization for up to 2 years
Total health care cost
Time Frame: From randomization for up to 2 years
From randomization for up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Navigator

Collaborators

Vastra Gotaland Region
Region Stockholm
Ostergotland County Council, Sweden
Uppsala County Council, Sweden

Investigators

  • Principal Investigator: Gustaf Edgren, gustaf@pheph.se

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN-AHS-HS-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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