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Patient Research In Self-Management of Asthma (PRISMA)

This study has been completed.

Sponsored by: Maastricht University Medical Center
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00411346
  Purpose

The objective of this study was to investigate if a nurse-led telemonitoring programme is effective and cost-effective in asthmatic outpatients, aged seven years and older.


Condition Intervention Phase
Asthma
Procedure: Nurse-led telemonitoring
Phase IV

MedlinePlus related topics:   Asthma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Nurse-Led Telemonitoring Programme in Asthmatic Outpatients: a Randomized Controlled Trial

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Asthma-specific quality of life at one year.

Secondary Outcome Measures:
  • Asthma symptoms at one year
  • generic quality of life at one year
  • direct and indirect costs during one year
  • satisfaction with and feasibility of the intervention at one year.

Estimated Enrollment:   112
Study Start Date:   January 2003
Estimated Study Completion Date:   November 2004

Detailed Description:

At the present day asthma is one of the most common chronic illnesses worldwide and the prevalence is still increasing. Asthma can be treated and controlled with guidance of health care professionals, and self-monitoring is an important aspect in this control.

Respiratory nurses have become common caregivers in the treatment and control of asthma. Advances in information and communication technology have created the potential to monitor the asthma status of patients at a distance, named telemonitoring. These two developments come together in nurse-led telemonitoring programmes. Lung function tests, from which the peak expiratory flow (PEF) is the most commonly used, are recorded into an electronic monitor. By transferring monitor data to a central database a nurse can continuously supervise the disease status of individual patients. The use of stepwise protocols can enable nurses to independently adjust the medication by one step.

Design: Randomized controlled trial comparing a nurse-led telemonitoring programme versus regular care in asthmatic outpatients aged 7 years and older.

Primary outcome parameter: asthma-specific quality of life. Secondary outcome parameters: symptoms, generic quality of life, direct and indirect costs, satisfaction.

  Eligibility
Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 7 years or older
  • Asthma severity of stage I - III as described in the GINA guidelines
  • Must be competent to use an asthma monitor
  • Must possess a household phone connection

Exclusion Criteria:

  • Respiratory co-morbidity
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411346

Locations
Netherlands, Limburg
University Hospital Maastricht    
      Maastricht, Limburg, Netherlands, 6202 AZ

Sponsors and Collaborators
Maastricht University Medical Center

Investigators
Study Chair:     Emiel FM Wouters, MD PhD     Department of Respiratory Medicine    
  More Information


Study ID Numbers:   02-157.1
First Received:   December 13, 2006
Last Updated:   December 13, 2006
ClinicalTrials.gov Identifier:   NCT00411346
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Asthma  
Self-Monitoring  
Cost-effectiveness  

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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