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.: PACTR202001497195086 Date of Approval: 17/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sweet Days
Official scientific title Effectiveness of a Mobile Phone Short Message Service on Glycemic Control and Adherence to Treatment for Type 2 Diabetes
Brief summary describing the background and objectives of the trial Diabetes is a chronic disease where type 1 diabetes (T1D) is due to autoimmune ẞ-cell destruction, usually leading to absolute insulin deficiency, type 2 diabetes (T2D) is due to a progressive loss of ẞ-cell insulin secretion frequently on the background of insulin resistance. A third type-Gestational diabetes mellitus (GDM)-is diagnosed in the second or third trimester of pregnancy and was not clearly overt diabetes prior to gestation (American Diabetes Association. Lifestyle management can enhance diabetes care and it includes diabetes self-management education and support (DSMES), medical nutrition therapy, physical activity, smoking cessation counselling, and psychosocial care. However, health systems cannot control all the factors that influence a person’s overall health, as physicians are unable to check regularly what their patients eat or whether they properly adhere to their medications. Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist’s practice extend beyond the traditional role. Patients and care providers should work together to optimize lifestyle aspects through the entire care process. Telemedicine “healing at a distance” signifies the use of information and communication technology to improve patient outcomes by increasing access to care and medical information. Using mobile and wireless technologies to achieve health objectives (mHealth) can universally transform health services’ delivery (WHO Global Observatory for eHealth, 2011). Mobile phones can easily reach population since they have exceeded other communication technologies in Low and middle-Income countries (LMICs). The results of the present study will help the policy-makers in the MOHP to understand the importance of creating healthcare systems that meet the needs of patients and providers and develop DSMES strategy with the help of pharmacist educator and using innovative mobile phone technology.
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 01/03/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/03/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 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 Mobile phone short message service 3 to 5 days per week 6 months • Mobile phone SMSs will be sent to the intervention group with the aim of improving medication adherence and knowledge about diabetes, its complications, diet and physical activity. • SMS content will be adopted from the validated Arabic national and international diabetes educational materials (Centers for Disease Control [CDC], 2018; Diabetes Australia, 2004; Diabetes Queensland, 2012; Utah Diabetes Control Program, 2005). • The mobile phone SMSs will be pre-tested for clarity on a sample of 10 patients similar to the study population and their comments on the SMSs wording will be used to modify them to ensure acceptance. • The SMS will be sent to participants using the internet, open-source software for bulk messages and a local telephone network provider. • Patients will be encouraged to send messages/call the researcher for any queries encountered. 50
Control Group non 6 months non-intervention group 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age: 18 years old and more. • Diagnosed with T2D up to 15 years according to the American Diabetes Association (ADA) standards (ADA, 2018). • With poorly controlled diabetes, (pre-intervention HbA1c values of 7% up to 10%). • Registered in the selected PHC centers and living in Alexandria. • Currently on oral medication therapy (if purchased from the center pharmacy) and able to afford the cost for 6 months treatment (if purchased from an external pharmacy). • Has a personal mobile phone. • Know how to retrieve/read SMS on a mobile phone (Arabic alphabets). • Available for the study duration. Patients with clinical conditions that might interfere with the study such as pregnancy, mental illness, poor eyesight, hearing or vocalization, visual, renal or liver impairment, other serious illness or co-morbidities requiring hospitalization. Adolescent: 13 Year-18 Year,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 26/11/2019 High Institute of Public Health Alexandria University
Ethics Committee Address
Street address City Postal code Country
165 El-Horreya Avenue, El-Ibrahimia, Alexandria, Egypt Alexandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the effect of the intervention on patients with type 2 diabetes in terms of glycemic control (HbA1c level). 0, 3 and 6 months
Secondary Outcome To assess the effect of the intervention on patients with type 2 diabetes in terms of: • Adherence to the prescribed hypoglycemic medications. • Diabetes-related knowledge. 0, 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Amrawy Family Healthcare Centers Al-Amrawy, Al-Montaza Alexandria Egypt
Al Mandara Family Health Center Al-Mandara, Al-Montaza Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rehab A. Rayan 15 Masjid Al-Hady St, Al-Montaza Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High Institute of Public Health Alexandria University 165 El-Horreya Avenue, El-Ibrahimia, Alexandria, Egypt Alexandria 21516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nawal Khalafallah 1 el-Khartoum square, azarita Alexandria Egypt
Ahmed Sharaf Aldin East Kantara, New City, El Ismailia El Ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab Rayan rayanr@alexu.edu.eg +201100505382 15 Masjid Al-Hadi St, Al-Montaza
City Postal code Country Position/Affiliation
Alexandria 21539 Egypt PhD Researcher
Role Name Email Phone Street address
Public Enquiries Nessrin El Nimr dr.elnimr@gmail.com +2034285575 165 El-Horreya Avenue, El-Ibrahimia, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor Department of Epidemiology High Institute of Public Health Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Aida Reda aidareda@hotmail.com +2034285575 165 El-Horreya Avenue, El-Ibrahimia, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Professor Department of Epidemiology High Institute of Public Health Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The link to summary results. Study Protocol Within 12 months of the study completion date. Access will be controlled and requests shall be directed to the trial primary investigator for review and decision.
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