Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595381
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Early Detection of Patients with Eating Disorders in General Practice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Detection of Patients with Eating Disorders in General Practice
Status:
NOT_YET_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:
None
Brief Summary:
The goal of this observational study is to assess the efficacy of the Eating Disorder Proxy Screening Tool for General Practitioner ED-PSTGP as a tool for the early detection of eating disorders EDs in General Practice GP The ED-PSTGP is a hetero-evaluative questionnaire that investigates the presence of suspected eating disorder symptoms among the family members of the person completing the questionnaire The study will involve adult patients over 18 years old enrolled in a general practice and their family members aged 16 years or older
The main questions it aims to answer are
Can the ED-PSTGP questionnaire effectively identify patients with potential eating disorders through responses from a family member
How effective is the ED-PSTGP questionnaire in general practice as an early detection tool for eating disorders
Participants will
Be asked by their General Practitioner GP to complete the ED-PSTGP questionnaire
If a positive result is found invite the potentially affected family member to complete additional screening questionnaires online
The potentially affected family member will be offered a teleconsultation with specialists and encouraged to contact the nearest reference center for ED treatment to further investigate potential eating disorders
The main questions it aims to answer are
Can the ED-PSTGP questionnaire effectively identify patients with potential eating disorders through responses from a family member
How effective is the ED-PSTGP questionnaire in general practice as an early detection tool for eating disorders
Participants will
Be asked by their General Practitioner GP to complete the ED-PSTGP questionnaire
If a positive result is found invite the potentially affected family member to complete additional screening questionnaires online
The potentially affected family member will be offered a teleconsultation with specialists and encouraged to contact the nearest reference center for ED treatment to further investigate potential eating disorders
Detailed Description:
Eating Disorders EDs represent a serious public health issue that in recent years has taken on the characteristics of a true social epidemic Timely diagnosis and treatment play a crucial role in the resolution of the disorder and in the prevention of chronic complications Unfortunately many individuals seek care with significant delay resulting in severe prognostic consequences and a high risk of chronicity General Practitioners GPs as primary care providers in direct contact with the public often represent the first point of contact between patients and the National Health System The families of those affected by these disorders can play a crucial role in the diagnostic-therapeutic process by identifying the symptoms early which may appear very subtle in the initial stages
STUDY DESIGN Forty GPs distributed across the national territory and selected by the Italian Society of Preventive Medicine and Lifestyle SIMPeSV will collaborate in the study Enrollment will be non-competitive and each participating GP will be required to administer the ED-PSTGP questionnaire to 30 adult patients
The GP will be responsible for evaluating the test The presence of a positive answer to any of the 13 items in the questionnaire will be considered sufficient to raise a suspicion of ED Patients who complete a test evaluated as positive will be asked to provide the following questionnaires to the potentially affected family member
Eating Disorder Screen for Primary Care ESP
Sick Control One stone Fat Food SCOFF
Disordered Eating Questionnaire DEQ
Beck Depression Inventory II BDI II The questionnaires and informed consent will be offered on an online platform and in Italian language
The family members indicated as potentially affected by EDs will be offered a teleconsultation with the operators from the Nutrition Science Research Unit of the University of Rome La Sapienza and the Clinical Psychology and Counseling Service of the University of Rome La Sapienza to further investigate the suspicion of eating disorder
The GP will encourage individuals with suspected ED to contact the nearest reference center for ED treatment for diagnostic confirmation and possible management
STUDY DESIGN Forty GPs distributed across the national territory and selected by the Italian Society of Preventive Medicine and Lifestyle SIMPeSV will collaborate in the study Enrollment will be non-competitive and each participating GP will be required to administer the ED-PSTGP questionnaire to 30 adult patients
The GP will be responsible for evaluating the test The presence of a positive answer to any of the 13 items in the questionnaire will be considered sufficient to raise a suspicion of ED Patients who complete a test evaluated as positive will be asked to provide the following questionnaires to the potentially affected family member
Eating Disorder Screen for Primary Care ESP
Sick Control One stone Fat Food SCOFF
Disordered Eating Questionnaire DEQ
Beck Depression Inventory II BDI II The questionnaires and informed consent will be offered on an online platform and in Italian language
The family members indicated as potentially affected by EDs will be offered a teleconsultation with the operators from the Nutrition Science Research Unit of the University of Rome La Sapienza and the Clinical Psychology and Counseling Service of the University of Rome La Sapienza to further investigate the suspicion of eating disorder
The GP will encourage individuals with suspected ED to contact the nearest reference center for ED treatment for diagnostic confirmation and possible management
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