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.: PACTR202404590004530 Date of Approval: 04/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Enhancing Self-Care Management in Diabetic Patients
Official scientific title Enhancing Self-Care Management in Diabetic Patients: A Randomized Controlled Trial Exploring the Interplay of Social Support, Self-Efficacy, and Empowerment
Brief summary describing the background and objectives of the trial Complications of Diabetes are preventable to a large degree through health education and increasing public awareness, so, it is important to study the effect of health education. Self-care management gives the patient the feeling of responsibility that will give them much better control. Some factors that affect the improvement of diabetes management as social support and self-efficacy. This research aims to explore to what extent the educational program improves the knowledge and practice of type 2 diabetic patients regarding their self-care management. Additionally, to explore the effect of social support and self-efficacy scales among diabetic patients attending the diabetes clinic at Zagazig University Hospitals.
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 Supportive care
Anticipated trial start date 01/03/2024
Actual trial start date 01/03/2024
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 01/07/2024
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants) 330
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education group Patients in the experimental group will receive the health education program through two sessions per week with a duration of half an hour for 4 weeks; it will be given orally and will be assisted by using many materials such as printed pamphlets that will be given to the patients. Four weeks The health education program will be given to the patients about self-management; diet, exercise, complications of diabetes, compliance to treatment, and investigations of DM. Skills will be learned regular foot care & the insulin injection technique. 165
Control Group Routine care group Routine care. Four weeks. Routine care. 165 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Type 2 diabetic patients confirmed more than 1 year duration. 2- Diabetic patients had regular visits to the diabetic outpatient clinic. 1- Patients with other chronic disease ( i.e . hepatic and cardiac diseases). 2- Cases with incomplete data. 3- Gestational diabetes. 4- Refusing to participate. Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 03/03/2024 Faculty of Medicine Zagazig University
Ethics Committee Address
Street address City Postal code Country
Rd inside Zagazig University Zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge regarding diabetes self-management Pre-intervention and three months post-intervention.
Primary Outcome Practice of diabetes self-management. Pre-intervention and three months post-intervention.
Secondary Outcome Glycated hemoglobin - HbA1C Pre-intervention and three months post-intervention.
Secondary Outcome Fasting blood glucose. Pre-intervention and three months post-intervention.
Secondary Outcome Body Mass Index BMI Pre-intervention and three months post-intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Diabetic outpatient clinic of Zagazig university hospital. Rd inside Zagazig University Zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None - None Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zagazig University Rd inside Zagazig University Zagazig 44519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanaa Nofal HANofal@medicine.zu.edu.eg +201006806873 Rd inside Zagazig University
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Assistant Professor of Public Health
Role Name Email Phone Street address
Scientific Enquiries Hanaa Nofal HANofal@medicine.zu.edu.eg +201006806873 Rd inside Zagazig University
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Assistant Professor of Public Health
Role Name Email Phone Street address
Public Enquiries Hossam Tharwat Ali hossamtharwatali@gmail.com +201021493953 Qena
City Postal code Country Position/Affiliation
Qena 83621 Egypt Intern Physician at South Valley University Hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Statistical Analysis Plan,Study Protocol 2 years Controlled
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