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.: PACTR202311757227634 Date of Approval: 06/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of therapeutic education on quality of life of children with type 1 diabetes mellitus
Official scientific title Effect of diabetes self-management education on health related quality of life of North African children with type1 diabetes mellitus and their parents: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The introduction in the PubMed or Google Scholar engines of the combination of the following terms: “Diabetes mellitus type 1 (T1DM)”, “Health related quality of life (HRQoL)”, “Diabetes self-management education (DSME)”, “Child “ and “Parents” reported only one original paper from Africa treating the HRQoL and glycemic control of adolescents with T1DM and investigating the impact of an educational program. To the best of the authors’ knowledge, in Tunisia, no previous study assessed the effect of a program of DSME on HRQoL of children/adolescents patients with T1DM. The main aim of this study was to assess the effect of DSME on HRQoL of North African children/adolescents with T1DM and their parents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2020
Actual trial start date 02/01/2020
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 110
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diabetes self management education five months The content of the diabetes self-management program (DSMP) was written by the principal researcher and revised by the pediatrician. It was designed to help improve the intervention took place in the TBL room at the Faculty of Medicine in Sousse (1st floor). It consisted of five group sessions. Each group attended a 180-minute session over a 5-month period, with one session per month. During the intervention and follow-up periods, the families in the intervention group were in telephone contact with the researcher to discuss any problems they were experiencing. A T1DM education booklet, a care booklet and an emergency card were provided in the participants' mother tongue. The T1DM education booklet was designed by the principal investigator and reviewed by the pediatrician. It covered many information’s about T1DM in a simple and clear way: Child's glycaemia control and the child's and parent's quality of life. Several teaching methods were used during the educational sessions, including group discussion. This method helped patients and parents to share information and motivated them to comply with the content of the intervention. Visual aids were used in the form of power point presentations, a whiteboard, a booklet, a care booklet and a diabetic card. The educational sessions were led by the researcher and a multidisciplinary team (two clinical teachers, a dietician and a nurse). 54
Control Group Individual education by pediatrics 5 months Individual education by pediatrics is the usual care education demonstrated by a regular 5 minutes by the Paediatrician at the end of the patient’s consultation. 56 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children/adolescents who had a medical diagnosis of T1DM at least one year before the inclusion in the study They received only insulin analogues for at least three months They had a valid telephone number. Mental retardation Sensor neural disorder that interferes with normal communication Another chronic disease, such as celiac disease Children/adolescents who participated in another experimental survey during the study period Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 18 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 07/09/2021 Ethics comitee of the faculty of medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Mohamed Karoui street Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The HRQOL of children and parents were the primary outcomes of this study. first assessment was conducted in January 2020 and follow up assessment was conducted on November2022
Secondary Outcome Glycaemic control (HbA1c) and clinical characteristics. first assessment was conducted in January 2020 and follow up assessment was conducted on November2022
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Farhat Hached Hospital Mohamed Karoui street Sousse 4001 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
imen mohamed karoui sousse 4002 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor imen mohamed karoui sousse 4002 Tunisia no
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Imen Ben Abdesselem benabdesselem12imen@gmail.com 0021655682872 Mohamed Karoui
City Postal code Country Position/Affiliation
Sousse 4002 Tunisia Doctoral Researcher in Health Science Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries raoudha kebeili raoudha_kebaili@yahoo.fr 55682872 mohamed karoui
City Postal code Country Position/Affiliation
sousse 4002 Tunisia Pediatric Doctor Department of Pediatrics Hospital Farhat HACHED
Role Name Email Phone Street address
Scientific Enquiries JIHENE bouguila jbouguila@yahoo.fr 55682872 mohamed karoui
City Postal code Country Position/Affiliation
sousse 4002 Tunisia Pedatric Doctor Department of Pediatrics Hospital Farhat HACHED
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be shared after deidentification. The data will be shared and published in a scientific article. Study Protocol January 2020 to March 2023 They were included in the study, children/adolescents who had a medical diagnosis of T1DM at least one year before the inclusion in the study, who received only insulin analogues for at least three months and who had a valid telephone number.
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