Patient Research In Self-Management of Asthma (PRISMA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Asthma Self-Monitoring Cost-effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Nurse-led telemonitoring

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Emiel FM Wouters, MD PhD

Role: STUDY_CHAIR

Department of Respiratory Medicine

Locations

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University Hospital Maastricht

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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02-157.1

Identifier Type: -

Identifier Source: org_study_id