Cystic FibrosisSAFETIM-needsNCT03298685
SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers
An observational study of Cystic Fibrosis and Adolescent Behavior, run by University Hospital, Grenoble at 4 sites in France.
Trial summary
prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center Read more about this study
- Who is it for?
- Ages 17 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Adolescent Behavior
- What is being tested?
- semi structured interviews for all adolescents and their parent
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Jun 2017to 31 Dec 2018
- Phase
- Observational
- 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 17 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews their age will be between 17 and 23 years old. living followed in one of the 3 CF center
Who may be able to join
- CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews
Who cannot join
- none
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital, Clermont-Ferrand
Clermont-Ferrand, 63003
UniversityHospitalGrenoble
Grenoble, 38043
Hôpital Femme Mère Enfant, HCL
Lyon, 69322
South Hospital of Lyon, HCL
Pierre-Bénite, 69495
About this study
Official title: SAFETIM Besoins: Suivi Des Adolescents Des Familles et Des Equipes Pour Une Transition Idéale en Mucoviscidose Etude Des Besoins Adolescents et Parent Avant après Transition
prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center
Read the detailed description
Adolescent's and parent's needs will be studied, before the transition and their experiences of transition, in order to propose organizational national recommendations semi structured interview with adolescents and parents separately, before and after transition.
semi structured interviews will be conducted twice for each (adolescent and parents), the first in the 6 months before transition and the second in the 6 months after transition.
After their verbatims will be analyzed and the optimal organisation will be determined for the transition based according to their point of view.
At the end, the data from this study will be matched with data collected in a former study from care givers practices during transition in the french CF centers.
- Conditions
- Cystic Fibrosis, Adolescent Behavior
- Being tested
- semi structured interviews for all adolescents and their parent
- Keywords
- transition, care program, needs
- Medical subject headings
- Cystic Fibrosis, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi structured interviews for all adolescents and their parentOther
Before and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center. And every interview will be transcribed by an other person
| Study group | Role | What they receive |
|---|---|---|
| CF patient and parents cohort in 3 CF center | All adolescents for whom the transition to the adult center is scheduled within six months and their parent will be interviewed before and after transition. Receives: Other: semi structured interviews for all adolescents and their parent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify CF adolescents and their parents needs before transition
Qualitative analysis of interviews
Measured: During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.
Identify CF adolescents and their parents experience after transition
Qualitative analysis of interviews
Measured: During their systematic appointment at the CF center, patients will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed.
Secondary outcomes (4)
What do they need, to feel safe before transition
Identify patients and parents needs
Measured: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed
Do these needs of CFadolescent and their parents taken into account in the transition procedures
Do the procedures take into account the needs of patients and parents
Measured: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed
Which factors influence quality of transition other than TPE dimension.
Satisfaction level of Patients and Family After Transition
Measured: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
Identifying key points of the patient's personalized transition, the timing and personalization of the health care course during the transition
Measured: comparison between the results with health care practices one year after the last interview will be performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start12 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LLERENA catherine, MD, Principal investigator, CHU GA Grenobe France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298685
- Sponsor's protocol ID
- 38RC17.005
- Other IDs
- 2017-A00062-51
- Acronym
- SAFETIM-needs
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bregnballe V, Schiotz PO, Lomborg K. Parenting adolescents with cystic fibrosis: the adolescents' and young adults' perspectives. Patient Prefer Adherence. 2011;5:563-70. doi: 10.2147/PPA.S25870. Epub 2011 Nov 7.
PubMed 22114471Kreindler JL, Miller VA. Cystic fibrosis: addressing the transition from pediatric to adult-oriented health care. Patient Prefer Adherence. 2013 Dec 11;7:1221-6. doi: 10.2147/PPA.S37710.
PubMed 24376344Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6. doi: 10.1016/1054-139x(93)90143-d. No abstract available.
PubMed 8312295Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
PubMed 20040605Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 10.1542/peds.2014-1909. Epub 2014 Oct 6.
PubMed 25287460
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETIM Besoins: Suivi Des Adolescents Des Familles et Des Equipes Pour Une Transition Idéale en Mucoviscidose Etude Des Besoins Adolescents et Parent Avant après Transition
- ClinicalTrials.gov ID
- NCT03298685
- Acronym / sponsor ID
- SAFETIM-needs / 38RC17.005
- Conditions
- Cystic Fibrosis, Adolescent Behavior
- Keywords
- transition, care program, needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Oct 2017 (actual)
- 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.
prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center
Detailed description
Adolescent's and parent's needs will be studied, before the transition and their experiences of transition, in order to propose organizational national recommendations semi structured interview with adolescents and parents separately, before and after transition.
semi structured interviews will be conducted twice for each (adolescent and parents), the first in the 6 months before transition and the second in the 6 months after transition.
After their verbatims will be analyzed and the optimal organisation will be determined for the transition based according to their point of view.
At the end, the data from this study will be matched with data collected in a former study from care givers practices during transition in the french CF centers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF patient and parents cohort in 3 CF center | – | Other: semi structured interviews for all adolescents and their parentAll adolescents for whom the transition to the adult center is scheduled within six months and their parent will be interviewed before and after transition. |
Who may qualify
- Ages
- 17 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews their age will be between 17 and 23 years old. living followed in one of the 3 CF center
Key inclusion criteria (1 listed)
- CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| semi structured interviews for all adolescents and their parentBefore and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center. And every interview will be transcribed by an other person | Other | CF patient and parents cohort in 3 CF center |
Primary outcome
Identify CF adolescents and their parents needs before transition
Time frame: During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.
Qualitative analysis of interviews
Identify CF adolescents and their parents experience after transition
Time frame: During their systematic appointment at the CF center, patients will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed.
Qualitative analysis of interviews
4 secondary outcomes
What do they need, to feel safe before transition
Time frame: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed
Do these needs of CFadolescent and their parents taken into account in the transition procedures
Time frame: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed
Which factors influence quality of transition other than TPE dimension.
Time frame: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
Time frame: comparison between the results with health care practices one year after the last interview will be performed
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 30 Mar 2020.
- Background: PubMed 22114471Bregnballe V, Schiotz PO, Lomborg K. Parenting adolescents with cystic fibrosis: the adolescents' and young adults' perspectives. Patient Prefer Adherence. 2011;5:563-70. doi: 10.2147/PPA.S25870. Epub 2011 Nov 7.
- Background: PubMed 24376344Kreindler JL, Miller VA. Cystic fibrosis: addressing the transition from pediatric to adult-oriented health care. Patient Prefer Adherence. 2013 Dec 11;7:1221-6. doi: 10.2147/PPA.S37710.
- Background: PubMed 8312295Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6. doi: 10.1016/1054-139x(93)90143-d. No abstract available.
- Background: PubMed 20040605Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
- Background: PubMed 25287460Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 10.1542/peds.2014-1909. Epub 2014 Oct 6.
- Individual participant dataSharing planned: No
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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.
LLERENA catherine, MD principal investigator
CHU GA Grenobe France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Adolescent Behavior, run by University Hospital, Grenoble at 4 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 1 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Identify CF adolescents and their parents needs before transition (time frame: During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03298685, which also lists 5 linked publications.
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 30 Mar 2020.