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.: PACTR202305868919565 Date of Approval: 12/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Group education of insulin-treated diabetics : impact on the mastery of insulin injection technique.
Official scientific title Group education of insulin-treated diabetics : impact on the mastery of insulin injection technique.
Brief summary describing the background and objectives of the trial Insulin therapy is one of the mainstays of the medical management of diabetes; 150 to 200 million people in the world are on insulin . The injection of insulin poses several problems : - First, the injection is, in principle, an aggression against the organism. - The pejorative image associated with it, itself the result of false beliefs (end of life, suspected harm to the body, etc.). - Common side effects of insulin therapy (hypoglycaemia, weight gain) - The degradation of the quality of life that it can cause (time constraints imposed by injection schedules, etc.) - Social marginalization (difficulty practicing fasting for Ramadan, difficulty getting around, eating with family or friends in restaurants, etc.) These problems are often the result of or are aggravated by ignorance of roles, methods of use and adequate injection technique . Individual therapeutic education has certain limits in the mastery of the use of insulin. Group therapeutic education has potential advantages that can solve problems related to the mastery of insulin injection, and thus improve its acceptance, reduce its undesirable effects and its constraints. This work proposes to evaluate the impact of a therapeutic group education in hospitalization of weeks on the mastery of the insulin injection technique of a population of type 2 diabetics.
Type of trial CCT
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 27/04/2023
Actual trial start date 11/05/2023
Anticipated date of last follow up 26/05/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group inward individual therapeutic education Two sessions, 15-20 minutes for each session The control group will receive each, during his hospital admission, two individual therapeutic education sessions, assured by the investigator and a nurse expert in therapeutic education. 23 Active-Treatment of Control Group
Experimental Group Inward group therapeutic education Two sessions 15-20 minutes for each session , The experimental group will receive each two group sessions on insulin injection technique assured by the investigator assisted by a nurse expert in therapeutic education 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult diabetic patients (18-65) admitted for unbalanced diabetes at INNTA • on insulin for at least 6 months • Patients whose cognitive status hinders relevant data collection • Patients who withdrew their consent from the study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 14/02/2023 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 Injection technique mastery, evaluated by the score of the insulin injection technique questionnaire The discharge day of the patient
Secondary Outcome Satisfaction of care Discharge day
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 Strret 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.rnu.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 Ferchichi Ahlem ahlemferchichi362@gmail.com 0021622142325 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 We, the research team, declare that all individual participant data collected for the study will be available after deidentification Informed Consent Form,Study Protocol 6 months 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