Cystic Fibrosis, Diabetes
Conditions
Keywords
Cystic Fibrosis, Shared decision-making, Treatments of diabete
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.
Interventions
OTHERShared 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.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactQuitterie REYNAUD, MD
Backup ContactJulie HAESEBAERT, MD
Outcome results
None listed