Cystic FibrosisEarly Phase 1MUSENCT02122289
Muco Smartphone Exacerbation
A Early Phase 1 study testing Application of Smartphone and No application Smartphone in people with Cystic Fibrosis, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Application of Smartphone and No application Smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2014to Jan 2016
- Phase
- Early Phase 1
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CF diagnosis
- Patient able to receive phone call
- Patient who use regulary a smartphone
- age from 14 to 25
- Patients with at least 2 exacerbations before the entry.
- Stable patient at V1
Who cannot join
- Patients who are include in an interventional study
- Patient who is not able to read French language
- Patients with psychological disorder
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.
Patients actually follow in CRCM track exacerbations when visits out patient clinic and during phone call. If patients did not call or did not present regularly to out patient clinic, exacerbation detection came later and so increasde the burden and therapeutic pressure.
The objective of our study is to identify earlier the potential exacerbations and so decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use modern technologiessuch as smartphone in order to create alert when patients report weekly health satatus. We will compra patients randomize in control group with standart follow-up to patients randomize in the smartphone group.Moreover we will study the compliance and satisfactory degree of the use of this device in the interventional arm.
Read the detailed description
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.
- Conditions
- Cystic Fibrosis
- Being tested
- Application of Smartphone, No application Smartphone
- Keywords
- Exacerbation, QoL
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of SmartphoneDevice
Weekly questionnaire on smartphone
No application SmartphoneOther
No weekly questionnaire on smartphone
| Study group | Role | What they receive |
|---|---|---|
| Application of Smartphone | Experimental | Weekly questionnaire on Smartphone Receives: Device: Application of Smartphone |
| No application Smartphone | Placebo comparator | No Weekly questionnaire on Smartphone Receives: Other: No application Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of exacerbation
Measured: up to 6 months
Secondary outcomes (1)
Satisfactory status and compliance
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael CHIRON, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122289
- Sponsor's protocol ID
- 9172
- Acronym
- MUSE
- Status last verified
- Apr 2016
- First submitted
- 22 Apr 2014
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT02122289
- Acronym / sponsor ID
- MUSE / 9172
- Conditions
- Cystic Fibrosis
- Keywords
- Exacerbation, QoL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Apr 2014 (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.
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.
Patients actually follow in CRCM track exacerbations when visits out patient clinic and during phone call. If patients did not call or did not present regularly to out patient clinic, exacerbation detection came later and so increasde the burden and therapeutic pressure.
The objective of our study is to identify earlier the potential exacerbations and so decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use modern technologiessuch as smartphone in order to create alert when patients report weekly health satatus. We will compra patients randomize in control group with standart follow-up to patients randomize in the smartphone group.Moreover we will study the compliance and satisfactory degree of the use of this device in the interventional arm.
Detailed description
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of Smartphone | Experimental | Device: Application of SmartphoneWeekly questionnaire on Smartphone |
| No application Smartphone | Placebo comparator | Other: No application SmartphoneNo Weekly questionnaire on Smartphone |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- CF diagnosis
- Patient able to receive phone call
- Patient who use regulary a smartphone
- age from 14 to 25
- Patients with at least 2 exacerbations before the entry.
Key exclusion criteria (3 listed)
- Patients who are include in an interventional study
- Patient who is not able to read French language
- Patients with psychological disorder
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 |
|---|---|---|
| Application of SmartphoneWeekly questionnaire on smartphone | Device | Application of Smartphone |
| No application SmartphoneNo weekly questionnaire on smartphone | Other | No application Smartphone |
Primary outcome
Frequency of exacerbation
Time frame: up to 6 months
1 secondary outcome
Satisfactory status and compliance
Time frame: up to 6 months
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 12 Apr 2016.
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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.
Raphael CHIRON principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Application of Smartphone and No application Smartphone in people with Cystic Fibrosis, run by University Hospital, Montpellier at 2 sites in France.
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 6 inclusion and 3 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 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Frequency of exacerbation (time frame: up to 6 months). 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 12 Apr 2016.