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

NCT ID: NCT02251899

Last Updated: 2015-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Disease-Management intervention

Intervention Type BEHAVIORAL

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

Control group not receiving any in

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Ostergotland County Council, Sweden

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Health Navigator

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustaf Edgren

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Stockholms Läns Landsting

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Gustaf Edgren

Role: CONTACT

Facility Contacts

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Gustaf Edgren, MD PhD

Role: primary

+46708186862

References

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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.

Reference Type RESULT
PMID: 22960802 (View on PubMed)

Other Identifiers

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HN-AHS-HS-2

Identifier Type: -

Identifier Source: org_study_id

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