Clinical trial NCT00840892: (Cost-)Effectiveness Interdisciplinary Community-based COPD Management Program (INTERCOM)
Official title: Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maxima Medical Center
name: Erasmus Medical Center
name: The Netherlands Asthma Foundation
name: Stichting Astma Bestrijding, The Netherlands
name: Nutricia Netherlands
name: PICASSO: Partners in Care Solutions for COPD
First posted: 2009-02-11
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: dyspnea, quality of life, exercise performance measures, body composition measures and lung function
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Veldhoven/Eindhoven
country: Netherlands
facility: Maxima Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Annemie MWJ Schols, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.