Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients

Diabetes Clinical Trial

— FORAIDMUCO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04891159
• Other study ID #: 69HCL21_0085
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: April 2023

Study information

• Verified date: March 2021
• Source: Hospices Civils de Lyon
• Contact: Quitterie REYNAUD, MD
• Phone: 4 78 86 15 54
• Email: quitterie.reynaud[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Diabetes
• Diabetes Mellitus
• Fibrosis

Intervention

Other:
• Shared decision making
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.

Locations

Country	Name	City	State
France	CRCM Grenoble adulte - Hôpital Albert Michallon	La Tronche
France	CRCM Montpellier Mixte - Hôpital Arnaud de Villeneuve	Montpellier
France	CRCM Lyon adulte - Centre hospitalier Lyon Sud	Pierre-Bénite
France	CRCM Rennes adulte - Hôpital Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)