Patient Research In Self-Management of Asthma (PRISMA)

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411346
• Other study ID #: 02-157.1
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2006
• Last updated: December 13, 2006
• Start date: January 2003
• Est. completion date: November 2004

Study information

• Verified date: December 2006
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Nurse-led telemonitoring

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma-specific quality of life at one year.
Secondary	Asthma symptoms at one year
Secondary	generic quality of life at one year
Secondary	direct and indirect costs during one year
Secondary	satisfaction with and feasibility of the intervention at one year.