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.: PACTR202404893787653 Date of Approval: 17/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of mHealth Intervention on Improving Lifestyle, and Health-Related Quality of Life among Type 2 Diabetes Mellitus Patients in Amhara Region Ethiopia
Official scientific title The Effect of mHealth Intervention on Improving Lifestyle, and Health-Related Quality of Life among Type 2 Diabetes Mellitus Patients in Amhara Region Ethiopia
Brief summary describing the background and objectives of the trial Mobile technology, including mobile phones and smartphones, has been increasingly utilized in healthcare services globally, including in low-resource settings like Ethiopia. Mobile health (mHealth) initiatives, such as SMS-based reminders for medication adherence, are being implemented to improve healthcare access and outcomes. Providing diabetes education using mHealth would also offer a convenient, accessible, and personalized educational message to type 2 diabetes patients. Therefore, the main objective of this research project is to see the effect of mHealth interventions on improving lifestyle and health-related quality of life among type 2 diabetes patients in the Amhara region of Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2024
Actual trial start date
Anticipated date of last follow up 01/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 252
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile phone text message education 6 months A text-based mHealth intervention will be the study project's intervention. The health belief model (HBM) will be used to guide the text messages that will be sent. T2DM patients from hospitals that will be randomly assigned to the mHealth intervention will get text messages as part of the intervention. The messages' content will cover the susceptibility and severity of T2DM complications, the benefits and barriers of modifying one's lifestyle through diet and exercise, the capacity to maintain a healthy lifestyle, and events, people, or things that can motivate one to alter one's behavior. 126
Control Group Usual care 6 months Usual Care 126 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult type 2 diabetic patients (≥18 years) on diabetes treatment follow up • Type 2 diabetes patients owning mobile phone with available network, electricity, and • Type 2 diabetes patients who can read the text messages written in Amharic will be included in the study • T2DM patients seriously ill during the time of data collection • DM patients who have already developed complications (Chronic complications and acute complications) during data collection, • Patients without a mobile phone and those whose phone cannot show texts in Amharic 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 04/04/2024 Institutional Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
University of Gondar Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Type 2 diabetes patients improved lifestyle Within a week after the intervention
Primary Outcome Type 2 diabetes patients improved health-related quality of life Within a week after the intervention
Secondary Outcome Type 2 diabetes co-morbidity Within a week after the intervention
Secondary Outcome Type 2 diabetes anthropometric parameter Within a week after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debremarkos Debremarkos Debremarkos Ethiopia
Bahir Dar Bahir Dar Bahir Dar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Gondar Gondar Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Gondar Gondar Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maru Meseret marumeseret@gmail.com +251938279641 Debremarkos
City Postal code Country Position/Affiliation
Debremarkos Ethiopia Debremarkos University College of Medicine and Health Sciences Department of Health Informatics
Role Name Email Phone Street address
Scientific Enquiries Binyam Chaklu binigcms@gmail.com +251913875066 Gondar
City Postal code Country Position/Affiliation
Gondar Ethiopia Leader of eHealthLab Ethiopia Research group and Vice President for Research and Community Services at the University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Tesfahun Melese tesfahun.melese@uog.edu.et +251918779820 Gondar
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar College of Medicine and Health Sciences Department of Health Informatics
Role Name Email Phone Street address
Scientific Enquiries Zeleke Abebaw Zelekeabebaw7@gmail.com +251912270932 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia University of Gondar College of Medicine and Health Sciences Department of Health Informatics
Role Name Email Phone Street address
Public Enquiries Tadese Guadu tadeguade2@gmail.com +251911096660 Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar Institute of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The researchers/sponsors of this clinical trial are committed to promoting transparency and facilitating the sharing of individual participant data (IPD) to support the advancement of science and benefit the broader research community, healthcare providers, and patients. Anonymous IPD that underlie the results reported in this study will be made available upon reasonable request to researchers who provide a methodologically sound proposal. Informed Consent Form,Study Protocol The IPD will be made available for sharing starting six months after the publication of the primary study results and will continue to be accessible for a period of five years. Researchers interested in accessing the IPD must submit a formal request accompanied by a methodologically sound research proposal. The request will be evaluated by the research team to ensure the protection of participant privacy and the ethical use of the data. Contact Information For inquiries or requests related to IPD sharing, please contact; Name: Maru Meseret Tadele Email: marumeseret@gmail.com Phone: +251938279641
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