(Cost-)Effectiveness Interdisciplinary Community-based COPD Management Program (INTERCOM)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840892
• Other study ID #: INTERCOM_CCMO_P00.1631L
• Secondary ID: Neth Asthma Foun
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: February 16, 2018
• Start date: January 2002
• Est. completion date: March 2007

Study information

• Verified date: February 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• INTERdisciplinary COMmunity-based COPD management (INTERCOM)
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.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Maxima Medical Centre	Veldhoven/Eindhoven

Sponsors (7)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Erasmus Medical Center, Maxima Medical Center, Nutricia Netherlands, PICASSO: Partners in Care Solutions for COPD, Stichting Astma Bestrijding, The Netherlands, The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	dyspnea, quality of life, exercise performance measures, body composition measures and lung function