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

• Conditions: Diabetes; Cystic Fibrosis
• Interventions: Other: Shared decision making

• Registration Number: NCT04891159
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Study Start: 2021-09
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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...)

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Exclusion Criteria

• Patient with transplant
• Patient who have received insulin therapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shared decision making	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

Primary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (4)

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, France