NCT01512836

Brief Summary

This randomized controlled trial (RCT) will examine a nurse case management model for patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish municipality, and is performed in order to evaluate the use of case management as a tool in achieving integrated, quality and cost-effective care for this group of patients. The main objectives are to evaluate how case management influences on hospital admissions, mortality, quality of life and self care, as well as to compare costs and cost-effectiveness of case management vs. usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

January 15, 2012

Last Update Submit

March 31, 2015

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDCase managementCEAHealth economyQuality of Life

Outcome Measures

Primary Outcomes (1)

  • COPD hospitalization rates

    1 year (study inclusion - 12 months of follow-up)

Secondary Outcomes (4)

  • Mortality

    1 year (study inclusion - 12 months of follow-up)

  • Self Care

    A baseline measure at study inclusion and after 12 months of follow-up

  • Quality of Life (QoL)

    A baseline measure at study inclusion and after 12 months of follow-up

  • Cost-effectiveness of case management

    1 year

Study Arms (2)

Case Management

EXPERIMENTAL

The patients who are randomized to the intervention group will be assigned to case management. The case manager is expected to integrate care from a health maintenance and promotion perspective, where the overall goal is the promote and support the patients self care (see intervention description).

Behavioral: Case Management

Usual Care

NO INTERVENTION

Patients randomized to the usual care group will receive conventional health and social services. Patients in this group will not receive support from a case manager.

Interventions

Case ManagementBEHAVIORAL

Patients, who are randomized to the intervention group, will receive case management from a trained and experienced nurse. The case manager will carry out following tasks: * Formulation and implementation of care plans together with the patient * Monitoring of individual status and care plan effectuation * Overall coordination between health care providers * Support to the patient and their caregivers during times of transition related to health status and environmental changes (e.g. hospital to home) * Regular telephone consultations and home visits * Promote disease-self management through coaching

Also known as: Care management, integrated care, shared care
Case Management

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are clinically referred to rehabilitation at Aalborg Rehabilitation Center for their diagnosed COPD

You may not qualify if:

  • Patients living outside Aalborg municipality, or who is considering to move to another municipality or country in near future.
  • Patients without a telephone
  • Patients with dementia
  • Patients participating in other research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kronikerenheden, Nordjylland

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • Sorensen SS, Pedersen KM, Weinreich UM, Ehlers L. Economic Evaluation of Community-Based Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease. Appl Health Econ Health Policy. 2017 Jun;15(3):413-424. doi: 10.1007/s40258-016-0298-2.

    PMID: 27928660DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Case Management

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Sabrina S Sørensen, Ph.d.

    Kronikerenheden Nordjylland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d. student

Study Record Dates

First Submitted

January 15, 2012

First Posted

January 19, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

DK(1)