Patient Research In Self-Management of Asthma (PRISMA)

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00411346
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-11
• Status Verified: 2006-12
• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-13
• Last Update Submitted: 2006-12-13
• Study First Posted: 2006-12-14
• Last Update Posted: 2006-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asthma-specific quality of life at one year.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands