NCT00840892

Brief Summary

There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. Based on earlier succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre developed an integrated, inter-disciplinary approach to the management of COPD including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. This COPD management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals. The exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. A program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. This study investigates the (cost-)effectiveness of the COPD management program compared to usual care in a randomized controlled trial. Patients with moderate to severe COPD and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. The treatment group will participate in the COPD management program during the first 4 months after which they will be followed up for the remaining months. Both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. The analysis is conducted from a societal perspectice, including the program costs and all COPD-related direct costs within and outside the healthcare sector ans costs of lost productivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

January 1, 2002

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2009

First QC Date

February 10, 2009

Last Update Submit

February 16, 2018

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations

Secondary Outcomes (1)

  • dyspnea, quality of life, exercise performance measures, body composition measures and lung function

Study Arms (2)

Intercom

EXPERIMENTAL

INTERdisciplinary COMmunity-based COPD management (INTERCOM)

Other: INTERdisciplinary COMmunity-based COPD management (INTERCOM)

Usual Care

NO INTERVENTION

Interventions

INTERdisciplinary COMmunity-based COPD management (INTERCOM)OTHER

The INTERCOM program consisted of exercise training, education, nutritional therapy and smoking cessation support offered by local physiotherapists and dieticians in the proximity of the patient's home and by respiratory nurses in the hospital. The program was divided in a 4-month intensive intervention phase, followed by a 20-month maintenance phase.

Intercom

Eligibility Criteria

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

You may qualify if:

  • Moderate to severe COPD according to the recent GOLD guidelines
  • Reduced exercise capacity during an incremental exercise test of less than 70% of predicted normal values

You may not qualify if:

  • Lack of motivation to participate in the treatment program
  • Other pathologic conditions unabling participation in the training program (e.g. coronary, orthopaedic, neurological or severe endocrine disorders)
  • participation in other pulmonary rehabilitation projects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catharina Hospital

Eindhoven, Netherlands

Location

Maxima Medical Centre

Veldhoven/Eindhoven, Netherlands

Location

Related Publications (3)

  • van Wetering CR, Hoogendoorn M, Broekhuizen R, Geraerts-Keeris GJ, De Munck DR, Rutten-van Molken MP, Schols AM. Efficacy and costs of nutritional rehabilitation in muscle-wasted patients with chronic obstructive pulmonary disease in a community-based setting: a prespecified subgroup analysis of the INTERCOM trial. J Am Med Dir Assoc. 2010 Mar;11(3):179-87. doi: 10.1016/j.jamda.2009.12.083. Epub 2010 Feb 4.

    PMID: 20188315DERIVED

  • van Wetering CR, Hoogendoorn M, Mol SJ, Rutten-van Molken MP, Schols AM. Short- and long-term efficacy of a community-based COPD management programme in less advanced COPD: a randomised controlled trial. Thorax. 2010 Jan;65(1):7-13. doi: 10.1136/thx.2009.118620. Epub 2009 Aug 23.

    PMID: 19703824DERIVED

  • Hoogendoorn M, van Wetering CR, Schols AM, Rutten-van Molken MP. Is INTERdisciplinary COMmunity-based COPD management (INTERCOM) cost-effective? Eur Respir J. 2010 Jan;35(1):79-87. doi: 10.1183/09031936.00043309. Epub 2009 Jul 2.

    PMID: 19574331DERIVED

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

  • Annemie MWJ Schols, Prof PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

January 1, 2002

Study Completion

March 1, 2007

Last Updated

February 19, 2018

Record last verified: 2009-02

Locations

NL(2)