Monitoring Asthma and COPD in Primary Care

NCT00542061 | Completed

• 1 other identifier: Picasso 04-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the clinical effectiveness and cost-effectiveness of a written expert advice for GPs on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring routines for patients with COPD or ashtma with a persistent obstruction in primary care based on a multicentre randomised nested clinical trial

Conditions

Lung Diseases, Obstructive; Asthma

Keywords

COPD; Asthma; Lung function; Monitoring; Primary Care

Outcome Measures

Primary Outcomes (1)

• Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR)

  At baseline, after one year follow-up, and after two years follow-up

Secondary Outcomes (2)

• Number of exacerbations; generic HRQoL (SF12); lung function indices; level of respiratory symptoms (MRC); satisfaction with the health care received (EuroPep); direct and indirect medical costs.

  Yearly: SF12, MRC, exacerbations; At baseline and end of the trial: EuroPEP, lung function indices; Continues by general practitioner registration: costs and exacerbations

• Moreover special attention will be paid to process evaluation (e.g, compliance to recommendations by general practitioner and patients).

  half-yearly for general practitioners and yearly for patients

Study Arms (2)

A

EXPERIMENTAL

Device: monitoring services

Device: half-yearly monitoring routine

B

NO INTERVENTION

Control group: no monitoring procedures

Interventions

half-yearly monitoring routine DEVICE

A written expert advice for GPs on additional diagnostic, treatment, and referral of patients with asthma and COPD based on half-yearly monitoring routines (lung function assessments including extensive anamnese) supported by half-yearly visits of an AC nurse consultant to the general practices.

A

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is categorised as asthmatic disease with persistent airway obstruction or COPD in the monitoring system SHL confirmed by the most recent lung function assessment (FEV1/FVC \< 70% after BD and FEV1 ≥ 50% pred after BD) or (FEV1 \< 80% predicted after BD and ≥ 9% reversibility)
• The patient is monitored by the AC service of the SHL.
• The GP of the patient is willing to participate in the trial.
• Written informed consent of participant

You may not qualify if:

• Patients treated primary by a pulmonologist
• Patients currently participating in another respiratory intervention study
• When the GP considers it detrimental to the patient to participate in the study
• Serious other non-pulmonary diseases (or disease-stages) that are presumed to lead to "lost to follow-up" because of the severity of the disease course (like diseases with low survival rate or mental deterioration)
• Serious other pulmonary diseases that effect bronchial symptoms and/or lung function, e.g. sarcoidosis, lung cancer, lung fibrosis
• Illiteracy

Sponsors & Collaborators

• Radboud University Medical Center: lead
• PICASSO: Partners in Care Solutions for COPD: collaborator

Study Sites (1)

Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)

Etten-Leur, Netherlands

Location

Related Publications (1)

• van den Bemt L, Schermer TR, Smeele IJ, Boonman-de Winter LJ, van Boxem T, Denis J, Grootens-Stekelenburg JG, Grol RP, van Weel C. An expert-supported monitoring system for patients with chronic obstructive pulmonary disease in general practice: results of a cluster randomised controlled trial. Med J Aust. 2009 Sep 7;191(5):249-54.

  PMID: 19740044 DERIVED

Related Links

• Website Radboud University Nijmegen Medical Centre

MeSH Terms

Conditions

Lung Diseases, Obstructive; Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tjard Schermer, PhD

  Radboud University Nijmegen Medical Centre, department of general practice

  STUDY DIRECTOR

• Lisette van den Bemt, MSc

  Radboud University Nijmegen Medical Centre, department of general practice

  PRINCIPAL INVESTIGATOR

• Chris van Weel, MD PhD professor

  Radboud University Nijmegen Medical Centre, department of general practice

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: October 10, 2007
• Study Start: March 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: April 1, 2008
• Last Updated: March 9, 2010

Record last verified: 2007-10

Locations

NL (1)