Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620770
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Impact of the Therapeutic Education Program Living With a Chronic Inflammatory Disease Under Biotherapy on Patient Compliance and Quality of Life
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of the Therapeutic Education Program Living With Chronic Inflammatory Disease Under Biotherapy on Compliance and Quality of Life of Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPEBIO
Brief Summary:
Patient therapeutic education programs have been shown to be effective in many specialties allowing Improving biological and psychological parameters allowing patients to improve their health knowledge therapeutic adherence and sense of personal effectiveness Several studies have shown that patient knowledge adherence and satisfaction are better after attending a therapeutic education program
This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy followed by dermatologists rheumatologists and gastroenterologists of the Lorient hospital
The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient living with a chronic inflammatory disease under biotherapy on treatment adherence as well as the positive impact on quality of life
This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy followed by dermatologists rheumatologists and gastroenterologists of the Lorient hospital
The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient living with a chronic inflammatory disease under biotherapy on treatment adherence as well as the positive impact on quality of life
Detailed Description:
All patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology rheumatology hepatotherapygastroenterology will be offered participation in the therapeutic education program by GHBS specialists Whether they agree to participate or not doctors will offer them participation in the IMPEBIO study
Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group
Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group The therapeutic education program will begin within 3 months of inclusion
If the patient does not object the Morisky scale and the SF 12 questionnaire will be given to him It may be assisted with filling if necessary by a clinical researcher
Patients will first complete the Morisky test and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study J0 then to M6 6 months M12 12 months and M18 18 months
These questionnaires will then be retrieved anonymized and sent to the investigation department The analysis of questionnaires will not lead to changes in patient management
Estimated time to complete the questionnaires is 10 minutes
Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group
Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group The therapeutic education program will begin within 3 months of inclusion
If the patient does not object the Morisky scale and the SF 12 questionnaire will be given to him It may be assisted with filling if necessary by a clinical researcher
Patients will first complete the Morisky test and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study J0 then to M6 6 months M12 12 months and M18 18 months
These questionnaires will then be retrieved anonymized and sent to the investigation department The analysis of questionnaires will not lead to changes in patient management
Estimated time to complete the questionnaires is 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None