Patient Research In Self-Management of Asthma (PRISMA)

Study Overview
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Procedure: Nurse-led telemonitoring


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Nurse-led telemonitoring|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma-specific quality of life at one year. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Self-Monitoring, Cost-effectiveness