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.: PACTR202306494299424 Date of Approval: 06/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of therapeutic education using a facebook group on the self-care practices of women with gestational diabetes
Official scientific title Impact of therapeutic education using a facebook group on the self-care practices of women with gestational diabetes
Brief summary describing the background and objectives of the trial Gestational diabetes is a very common condition, affecting up to 16% of pregnancies. Its complications, both maternal and fetal, can be reduced by strict management, based on the hygieno-dietetic component, the practice of self-monitoring, and, if necessary, anti-diabetic drug treatment. The benefit of therapeutic education in improving self-care practices and in improving the prognosis of pregnancy in patients with gestational diabetes is well established. However, this health problem has particularities: - Need for an optimal level of knowledge on self-care practices - Need for strict and regular support - A significant and continuous need for information, linked to a new condition - The high prevalence of false beliefs and misrepresentations Conventional, health-care-structure-based care has structural shortcomings, making adaptation to these particularities problematic. Increasingly, the Internet and social networks, because of their availability, their ease of use, platforms that make data sharing fluid, have become an important determinant in the therapeutic education of diabetics. , and, in this case, gestational diabetes. These advantages could compensate for the shortcomings of conventional care. However, their use for Tunisian pregnant women remains marginal in practice. We propose to carry out a work which aim is to compare the effects on self-care practices of an online therapeutic education platform via a facebook group in addition to traditional care versus traditionnal care alone.
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 24/02/2023
Actual trial start date 24/02/2023
Anticipated date of last follow up 10/04/2023
Actual Last follow-up date 10/04/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 therapeutic education in addition to usual care Usual care : a consultation every 15 days Facebook group based education : one to two publications per day 30 days The patients receive, in addition to conventionnal care ( a nutritionnist, and a doctor consultation every 15 days for evaluation and therapeutic education) a facebook based therapeutic education in which : * One to two publications will be assured, with main gestationnal diabetes care topics will be discussed and underlined ( dietetics, self glucose monitoring, physical activity, prognosis ) * An interactive plateform with the patients will be put (group messenger and the comment section) in which they can answer questions related to the topic. 30
Control Group usual care a consultation of 30 minutes every 15 days a month The control group will only receive the usual car, ie a consultation of 30 minutes in the hospital in which the patient meets the doctor, the nutritionnist for evaluation and therapeutic education. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Every woman recently diagnosed with Gestationnal diabetes Possession of a facebook account Pregnant women already diabetic Absence of consent Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
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 Self care practices, evaluated by the diabetes self care activities questionnaire, in its arabic version, validated for gestationnal diabetes patients. 30 days
Secondary Outcome Number of times self glucose monitoring is performed in a week 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute of Nutrition and Food Technology 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 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Nutrition and Food Technology 11, Jebel Lakhdhar Street Tunis Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
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 Lahmadi Angham anghamlahmadi781@gmail.com 0021624773256 Manouba
City Postal code Country Position/Affiliation
Tunis Tunisia Nursing student
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 Tunisia Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we, the research team, declare that all individual participant data collected for this study will be available after deidentification. Informed Consent Form,Study Protocol 6 months after trial completion 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