NCT00702078

Brief Summary

We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD. The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

7.7 years

First QC Date

June 19, 2008

Last Update Submit

January 9, 2017

Conditions

Keywords

COPDhome-based treatmentearly intervention

Outcome Measures

Primary Outcomes (1)

  • Number of hospitalizations

    2011

Secondary Outcomes (4)

  • quality of life

    2011

  • lung function

    2011

  • use of medication

    2011

  • cost-effectiveness

    2011

Study Arms (2)

usual care

OTHER

follow-up according to todays best practice.

Behavioral: usual care

cooperation

EXPERIMENTAL

Follow-up from the hospital and the primary healthcare in cooperation

Behavioral: closer collaboration between hospital and primary healthcare system

Interventions

Follow-up from the hospital and the primary healthcare in cooperation

cooperation
usual careBEHAVIORAL

follow-up according to todays best practice

usual care

Eligibility Criteria

AgeUp to 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of COPD (III-IV)
  • receive help from homecare nurse
  • not suffering from any other serious disease, with expected lifespan less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Lung Diseases, St.Olavs Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Titova E, Salvesen O, Bentsen SB, Sunde S, Steinshamn S, Henriksen AH. Does an Integrated Care Intervention for COPD Patients Have Long-Term Effects on Quality of Life and Patient Activation? A Prospective, Open, Controlled Single-Center Intervention Study. PLoS One. 2017 Jan 6;12(1):e0167887. doi: 10.1371/journal.pone.0167887. eCollection 2017.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anne Hildur Henriksen, MD,PhD

    St.Olavs Hospital HF

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations