Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304720682563 Date of Approval: 24/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diabetic foot care: evaluation of therapeutic education with a facebook group as a framework
Official scientific title Diabetic foot care: evaluation of therapeutic education with a facebook group as a framework
Brief summary describing the background and objectives of the trial The diabetic foot is a leading cause of non-traumatic amputation worldwide. It is all the more problematic as the majority of its complications are avoidable. Therapeutic education is the mainstay of diabetic foot care. Its purpose is to ensure a level of knowledge and practice of diabetic foot care that will prevent its complications . Education on foot care, despite its importance, remains relatively neglected for diabetics ; evidence of this is the mediocre level of foot care knowledge and practices. This is due to several factors, including the prioritization of other aspects of therapeutic education (treatment, self-monitoring, dietetics), deemed more profitable in terms of time (education of foot care being quite substantial, and the time allocated to each patient being limited). Therefore, in order to overcome the shortcomings of the traditional doctor-patient interface (consultation, hospitalization), the concept of online education for foot care is being developped . It has the advantage of providing information that is available at all times, and that the patient can review repeatedly. Social networks have, in addition, the advantage of interaction between its users, potentiating data sharing. However, this is a subject that remains, to our knowledge, undeveloped in Tunisia. This trial primary objective is to evaluate the impact of a therapeutic education centered on foot care using social networks on foot care practice in a Tunisian population of type 2 diabetics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 14/04/2023
Actual trial start date 20/04/2023
Anticipated date of last follow up 14/05/2023
Actual Last follow-up date 24/05/2023
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Facebook group based foot care therapeutic education one to two publications a day in the group wall 15 days The intervention group will receive during 15 days a facebook based therapeutic education on diabetic foot care, during which one to two publications ( in the form of short videos, pictures, texts) will be made in the group wall, each containing a message related to either preventive care, or lesions management ( in total, the same messages of the face to face education will be given); This in addition to the possibility of interaction by the patient in the comment or group messenger section. 35
Control Group Face to face education two sessions three days The control group will receive, during the admission, two group face to face sessions related to diabetic foot care, of 60 minutes each performed by the investigators, assisted by a nurse expert in diabetic foot care. The first session will focus on preventive care, the second on the early management of diabetic foot lesions. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult type 2 diabetic patients admitted to the National Institute of Nutrition and Food Technology • Possession of a facebook account, • Patients whose cognitive status hinders relevant data collection • Patients who withdrew their consent from the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/01/2023 Ethics committee of the National Institute of Nutrition and Food technology
Ethics Committee Address
Street address City Postal code Country
11 Jebel Lakhdhar Street Tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Foot care practice, assessed by the score of Foot Care Practice Questionnaire, validated in arabic 15 days
Secondary Outcome Satisfaction of the education course 15 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute of Nutrition and Food Technology of Tunis 11, Jebel Lakhdhar street Tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Gharbi Radhouen 1 Palestine street Menzel Bourguiba 7050 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Nutrition and Food technology of Tunis 11, Jebel Lakhdhar street Tunis 1007 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Gharbi Radhouen radhouen.gharbi@fmt.utm.tn 0021626857246 1 Palestine street
City Postal code Country Position/Affiliation
Menzel Bourguiba 7050 Tunisia Assistant professor
Role Name Email Phone Street address
Public Enquiries Kammoun Ines ines.kammoun@fmt.utm.tn 0021698352605 El Manar
City Postal code Country Position/Affiliation
Tunis Tunisia Professor
Role Name Email Phone Street address
Principal Investigator Rjaibi Eya eyarjeibi8@gmail.com 0021622069693 Bardo
City Postal code Country Position/Affiliation
Tunis Tunisia Nursing student
Role Name Email Phone Street address
Principal Investigator Saidi Nour Saidinour587@gmail.com 0021653413103 Bardo
City Postal code Country Position/Affiliation
Tunis Tunisia Nursing student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes For the present study, we, the research team, declare that all individual participant data collected for the study will be available after deidentification. Informed Consent Form,Study Protocol Availability will be 6 months after registration of the trial Mail Dr Gharbi Radhouen via his institutionnal mail : radhouen.gharbi@fmt.utm.tn via a formal request . All data collected will be available in addition to study protocol and informed consent Form. The access request is open, but must be justified .
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information