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Clinical Trials/NCT00411346
NCT00411346
Completed
Phase 4

Nurse-Led Telemonitoring Programme in Asthmatic Outpatients: a Randomized Controlled Trial

Maastricht University Medical Center1 site in 1 country112 target enrollmentJanuary 2003
ConditionsAsthma

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Asthma
Sponsor
Maastricht University Medical Center
Enrollment
112
Locations
1
Primary Endpoint
Asthma-specific quality of life at one year.
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
November 2004
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Asthma-specific quality of life at one year.

Secondary Outcomes

  • 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.

Study Sites (1)

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