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

The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02251899
• Other study ID #: HN-AHS-HS-2
• Status: Recruiting
• Phase: Phase 3
• First received: September 25, 2014
• Last updated: March 26, 2015
• Start date: January 2010
• Est. completion date: June 2016

Study information

• Verified date: March 2015
• Source: Health Navigator
• Contact: Gustaf Edgren
• Email: gustaf[@]pheph.se
• Is FDA regulated: No
• Health authority: Ethics review board: Sweden
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure
• The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure

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

Locations

Country	Name	City	State
Sweden	Stockholms Läns Landsting	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Health Navigator	Ostergotland County Council, Sweden, Stockholm County Council, Sweden, Uppsala County Council, Sweden, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Reinius P, Johansson M, Fjellner A, Werr J, Ohlén 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.0b013e328358b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospitalizations		From randomization for up to 2 years	No
Primary	Number of outpatient visits to medical doctor		From randomization for up to 2 years	No
Secondary	Mortality		From randomization for up to 2 years	Yes
Secondary	Length of hospital stays		From randomization for up to 2 years	No
Secondary	Total health care cost		From randomization for up to 2 years	No