Patient Research In Self-Management of Asthma (PRISMA)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Nurse-led telemonitoring
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma, Self-Monitoring, Cost-effectiveness
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
Sites / Locations
- University Hospital Maastricht
Outcomes
Primary Outcome Measures
Asthma-specific quality of life at one year.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00411346
First Posted
December 13, 2006
Last Updated
December 13, 2006
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00411346
Brief Title
Patient Research In Self-Management of Asthma (PRISMA)
Official Title
Nurse-Led Telemonitoring Programme in Asthmatic Outpatients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Self-Monitoring, Cost-effectiveness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Nurse-led telemonitoring
Primary Outcome Measure Information:
Title
Asthma-specific quality of life at one year.
Secondary Outcome Measure Information:
Title
Asthma symptoms at one year
Title
generic quality of life at one year
Title
direct and indirect costs during one year
Title
satisfaction with and feasibility of the intervention at one year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiel FM Wouters, MD PhD
Organizational Affiliation
Department of Respiratory Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Patient Research In Self-Management of Asthma (PRISMA)
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