DiabetesFORAIDMUCONCT04891159
Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients
An observational study of Diabetes and Cystic Fibrosis, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Cystic Fibrosis
- What is being tested?
- Shared decision making
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2021to Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major cystic fibrosis patients
Who may be able to join
- Concerning the patient :
- Patient major
- Patient affected by cystic fibrosis
- Patient able to understand french
- Patient sable on Respiratory and nutritional status
- Patient with disorders of carbohydrate metabolism in the glucose tolerance test (OGTT)
Show all 9Show fewer
- Patient with normal fasting blood sugar
- Concerning the health professionals :
- Medical and paramedical professionals practising in the adult Cystic Fibrosis Centers Competences (doctors, nurses, dieticians, psychologists, physiotherapists, etc...)
Who cannot join
- Patient with transplant
- Patient who have received insulin therapy
Trial locations and contacts
4 sites in 1 country.
France4 sites
CRCM Grenoble adulte - Hôpital Albert Michallon
La Tronche, 38700
CRCM Montpellier Mixte - Hôpital Arnaud de Villeneuve
Montpellier, 34295
CRCM Lyon adulte - Centre hospitalier Lyon Sud
Pierre-Bénite, 69495
CRCM Rennes adulte - Hôpital Pontchaillou
Rennes, 35033
About this study
Official title: Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients: a Qualitative Evaluation of the Implementation
Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate insulin treatment when he has developed symptoms and therefore later. In practice, the choice between these two options takes place over two medical consultations without a formalized shared decision-making process between the doctor and the patient.
Shared decision-making is a decision-making process in which the healthcare provider and the patient learn about patients care options and then deliberate to reach a common agreement on the decision taken.
Shared decision-making seemed particularly relevant to us in cystic fibrosis where there are complex treatment options with variable short-, medium- and long-term side effects and where the disease and its treatments have a high impact on the patient's quality of life.
- Conditions
- Diabetes, Cystic Fibrosis
- Being tested
- Shared decision making
- Keywords
- Cystic Fibrosis, Shared decision-making, Treatments of diabete
- Medical subject headings
- Diabetes Mellitus, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision makingOther
The intervention consists of 5 components: 1) Online shared decision making training (2 hours, e-learning); 2) Individual coaching for doctors by a shared decision making expert; 3) Implementation of the shared decision making; 4) Link to institutional approaches to patient engagement; 5) Integration of the shared decision making into the multidisciplinary consultation meetings of the Cystic Fibrosis Centers Competences.
| Study group | Role | What they receive |
|---|---|---|
| Shared decision making | During the first consultation (V1), the doctor will present the patient on the therapeutic treatment information related to diabetes according to the shared decision making (options, benefits, risks) with the assistance of decision support tools. The decision-making visit will take place after a reflection period of 8 to 15 days after V1. A discussion based on the feedback from this period of reflection will take place between the two actors and either there is a common agreement on the decision taken (shared decision-making), or the decision is taken by the patient, or the decision is made by the physician at the request of the patient. A social sciences and humanities methodologist will attend each consultation, onsite or in videoconferencing. After the consultation, he realized a semi-structured interview with the patient. During this interview, the patient filled the self-administered questionnaires: SDM-Q-9, SURE, CollaboRATE, Spielberger test and the research team questionnaire Receives: Other: Shared decision making | |
| Control group | Decision-making for insulin therapy is based on the usual practice defined in each Cystic Fibrosis Centers Competences with decision-making procedures specific to each center and doctor. The decision-making process is generally carried out in two consultations. A social sciences and humanities methodologist will attend each consultation, onsite or in videoconferencing. After the consultation, he realized a semi-structured interview with the patient. During this interview, the patient filled the self-administered questionnaires (SDM-Q-9, SURE, CollaboRATE, Spielberger test and the research team questionnaire). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of a shared decision making measured by the total score obtained on the 9 items of the shared decision making questionnaire (SDM-Q-9), translated into French.
The SDM-Q-9 is a self-administered questionnaire of 9 items coded on a 6-point Likert scale. A total score between 0 and 45 is calculated from the sum of the scores obtained for the 9 questions. This score is converted between 0 and 100 by multiplying by a factor of 20/9, 0 indicating a non adoption of shared decision making as perceived by the patient and conversely 100 indicating an adoption of shared decision making as perceived by the patient. The total score will be described in each group by mean, standard deviation, median, quartiles and extent, and will be compared between the 2 groups with a non-parametric Wilcoxon test.
Measured: The principal endpoint is measured for interventional group : immediately after the second consultation, for control group : immediately after the consultation where the treatment decision is taken (consultation 1 or 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study startSep 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891159
- Sponsor's protocol ID
- 69HCL21_0085
- Acronym
- FORAIDMUCO
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2021
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moumjid N, Gotte C, Hommey S, Poupon Bourdy S, Haesebaert J, Durieu I, Reynaud Q. Mixed Comparative Evaluation of a Training Program Dedicated to Cystic Fibrosis Reference Centers: Protocol for the Pilot Implementation of Shared Decision-Making in the Treatment of Diabetes in Adult Patients With Cystic Fibrosis. JMIR Res Protoc. 2025 Jan 28;14:e62931. doi: 10.2196/62931.
PubMed 39874570
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients: a Qualitative Evaluation of the Implementation
- ClinicalTrials.gov ID
- NCT04891159
- Acronym / sponsor ID
- FORAIDMUCO / 69HCL21_0085
- Conditions
- Diabetes, Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Shared decision-making, Treatments of diabete
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 18 May 2021 (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.
Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate insulin treatment when he has developed symptoms and therefore later. In practice, the choice between these two options takes place over two medical consultations without a formalized shared decision-making process between the doctor and the patient.
Shared decision-making is a decision-making process in which the healthcare provider and the patient learn about patients care options and then deliberate to reach a common agreement on the decision taken.
Shared decision-making seemed particularly relevant to us in cystic fibrosis where there are complex treatment options with variable short-, medium- and long-term side effects and where the disease and its treatments have a high impact on the patient's quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared decision making | – | Other: Shared decision makingDuring the first consultation (V1), the doctor will present the patient on the therapeutic treatment information related to diabetes according to the shared decision making (options, benefits, risks) with the assistance of decision support tools. The decision-making visit will take place after a reflection period of 8 to 15 days after V1. A discussion based on the feedback from this period of reflection will take place between the two actors and either there is a common agreement on the decision taken (shared decision-making), or the decision is taken by the patient, or the decision is made by the physician at the request of the patient. A social sciences and humanities methodologist will attend each consultation, onsite or in videoconferencing. After the consultation, he realized a semi-structured interview with the patient. During this interview, the patient filled the self-administered questionnaires: SDM-Q-9, SURE, CollaboRATE, Spielberger test and the research team questionnaire |
| Control group | – | –Decision-making for insulin therapy is based on the usual practice defined in each Cystic Fibrosis Centers Competences with decision-making procedures specific to each center and doctor. The decision-making process is generally carried out in two consultations. A social sciences and humanities methodologist will attend each consultation, onsite or in videoconferencing. After the consultation, he realized a semi-structured interview with the patient. During this interview, the patient filled the self-administered questionnaires (SDM-Q-9, SURE, CollaboRATE, Spielberger test and the research team questionnaire). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major cystic fibrosis patients
Key inclusion criteria (9 listed)
- Patient major
- Patient affected by cystic fibrosis
- Patient able to understand french
- Patient sable on Respiratory and nutritional status
- Patient with disorders of carbohydrate metabolism in the glucose tolerance test (OGTT)
Key exclusion criteria (2 listed)
- Patient with transplant
- Patient who have received insulin therapy
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 |
|---|---|---|
| Shared decision makingThe intervention consists of 5 components: 1) Online shared decision making training (2 hours, e-learning); 2) Individual coaching for doctors by a shared decision making expert; 3) Implementation of the shared decision making; 4) Link to institutional approaches to patient engagement; 5) Integration of the shared decision making into the multidisciplinary consultation meetings of the Cystic Fibrosis Centers Competences. | Other | Shared decision making |
Primary outcome
Adoption of a shared decision making measured by the total score obtained on the 9 items of the shared decision making questionnaire (SDM-Q-9), translated into French.
Time frame: The principal endpoint is measured for interventional group : immediately after the second consultation, for control group : immediately after the consultation where the treatment decision is taken (consultation 1 or 2)
The SDM-Q-9 is a self-administered questionnaire of 9 items coded on a 6-point Likert scale. A total score between 0 and 45 is calculated from the sum of the scores obtained for the 9 questions. This score is converted between 0 and 100 by multiplying by a factor of 20/9, 0 indicating a non adoption of shared decision making as perceived by the patient and conversely 100 indicating an adoption of shared decision making as perceived by the patient. The total score will be described in each group by mean, standard deviation, median, quartiles and extent, and will be compared between the 2 groups with a non-parametric Wilcoxon test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 39874570Moumjid N, Gotte C, Hommey S, Poupon Bourdy S, Haesebaert J, Durieu I, Reynaud Q. Mixed Comparative Evaluation of a Training Program Dedicated to Cystic Fibrosis Reference Centers: Protocol for the Pilot Implementation of Shared Decision-Making in the Treatment of Diabetes in Adult Patients With Cystic Fibrosis. JMIR Res Protoc. 2025 Jan 28;14:e62931. doi: 10.2196/62931.
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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.
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 Diabetes and Cystic Fibrosis, run by Hospices Civils de Lyon 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quitterie REYNAUD, MD (4 78 86 15 54 ext. +33, quitterie.reynaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of a shared decision making measured by the total score obtained on the 9 items of the shared decision making questionnaire (SDM-Q-9), translated into French. (time frame: The principal endpoint is measured for interventional group : immediately after the second consultation, for control group : immediately after the consultation where the treatment decision is taken (consultation 1 or 2)). 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 NCT04891159, which also lists 1 linked publication.
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 18 May 2021.