Clinical trial NCT04891159: Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Cystic Fibrosis
Keywords: Cystic Fibrosis
Shared decision-making
Treatments of diabete
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major cystic fibrosis patients

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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)
* 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...)

Exclusion Criteria:

* Patient with transplant
* Patient who have received insulin therapy

Primary outcomes:
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.
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CRCM Grenoble adulte - Hôpital Albert Michallon
city: Montpellier
country: France
facility: CRCM Montpellier Mixte - Hôpital Arnaud de Villeneuve
city: Pierre-Bénite
country: France
facility: CRCM Lyon adulte - Centre hospitalier Lyon Sud
city: Rennes
country: France
facility: CRCM Rennes adulte - Hôpital Pontchaillou
Study officials:
References: