AsthmaPhase 4NCT00411346
Patient Research In Self-Management of Asthma (PRISMA)
A Phase 4 study testing Nurse-led telemonitoring in people with Asthma, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Nurse-led telemonitoring
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Nov 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Respiratory co-morbidity
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Hospital Maastricht
Maastricht, Limburg, 6202 AZ
About this study
Official title: Nurse-Led Telemonitoring Programme in Asthmatic Outpatients: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Nurse-led telemonitoring
- Keywords
- Asthma, Self-Monitoring, Cost-effectiveness
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led telemonitoringProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma-specific quality of life at one year.
Secondary outcomes (4)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startJan 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Emiel FM Wouters, MD PhD, Study chair, Department of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411346
- Sponsor's protocol ID
- 02-157.1
- Status last verified
- Dec 2006
- First submitted
- 13 Dec 2006
- Last updated
- 14 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Telemonitoring Programme in Asthmatic Outpatients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00411346
- Acronym / sponsor ID
- 02-157.1
- Conditions
- Asthma
- Keywords
- Asthma, Self-Monitoring, Cost-effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Nov 2004
- First posted
- 14 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Respiratory co-morbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led telemonitoring | Procedure or surgery | – |
Primary outcome
Asthma-specific quality of life at one year.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiel FM Wouters, MD PhD study chair
Department of Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nurse-led telemonitoring in people with Asthma, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma-specific quality of life at one year.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2006.