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.: PACTR202401910674124 Date of Approval: 09/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of therapeutic education program on glycemic control and adherence in type 2 diabetic patients
Official scientific title The effect of therapeutic education program on glycemic control and adherence in type 2 diabetic patients: a randomized controlled trial
Brief summary describing the background and objectives of the trial Diabetes type 2 is a chronic disease requiring constant medical care, continuing therapeutic education and patient’s adherence to prescribed medication and recommendations. the overall aim of this study was to evaluate the effect of a therapeutic education program on self-care activities, therapeutic adherence and glycemic control and quality of life of type 2 diabetic patients.
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 16/05/2021
Actual trial start date 16/05/2021
Anticipated date of last follow up 15/07/2022
Actual Last follow-up date 15/07/2022
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants) 320
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Therapeutic education program for type 2 diabetic patients The program included three sessions each lasting for 45 minutes with an interval of 3 months 9 months The program included three sessions each lasting for 45 minutes with an interval of 3 months using direct face-to-face educational presentation, demonstrations and sharing information materials (booklet, leaflet and poster). Additional take-home materials containing mean items related to diabetes were written in a simple language with different colored images to facilitate patients' understanding. 160
Control Group usual diabetes care 9 months the control group received only the usual diabetes care such as medical visits and treatment. 160 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged at least 18 years old; having at least twelve months anti-diabetic treatment and having poor glycemic control (HbA1c >7%) in the last three months Exclusion criteria included an untreated mental disease; pregnancy and inability to communicate verbally. Those who were absent in any of the three educational sessions were excluded. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 16/12/2022 Committee for the Protection of Persons CPP SUD
Ethics Committee Address
Street address City Postal code Country
Road of Menzel Chaker, Erriadh Sfax 3003 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glycosylated hemoglobin, Medication adherence, Self-care adherence 3 months before the first session and 3 months after the last session
Secondary Outcome Quality of life 3 months before the first session and 3 months after the last session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CNSS Polyclinic Avenue of the Martyrs Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
No external funding No address Sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Imen Turki Road of Tunis Sfax 3021 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Imen Turki imen_turki1992@hotmail.fr 21621018092 Road of Tunis
City Postal code Country Position/Affiliation
Sfax 3021 Tunisia PhD candidate in health sciences
Role Name Email Phone Street address
Public Enquiries Mouna Mnif mnifmouna2020@gmail.com 21622679000 Avenue Majida Boulila
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Professor of medecine Endocrinology
Role Name Email Phone Street address
Scientific Enquiries Chekib Zedini chekib.zedini@gmail.com 21698409233 Avenue Mohamed Elkaroui
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Professor of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) will be a be available and shared after deidentification with investigators whose proposed use of the data has been approved by an independent review committee for individual participant metaanalysis Informed Consent Form Immediately following publication, No end date Publications
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