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.: PACTR202310649780044 Date of Approval: 13/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness Of The Soryol Diabetes Care App For Diabetes Management: A Randomised Control Trial
Official scientific title A Randomised Control Trial Evaluating The Efficacy And Suitability Of The Soryol Mobile App For Supportive Care In Type 2 Diabetes Patients
Brief summary describing the background and objectives of the trial Diabetes is an established cause of morbidity and mortality globally. Low- and middle-income countries with high proportions of poor and poorly educated citizens coupled with inadequate healthcare/health insurance systems and low treatment/spending have increasing rates of diabetes as well as mortality. Two fundamental drivers of mobile app use for diabetes management are the increase in both smart phone use and data penetration in developed countries. Both of these are currently on the increase in Nigeria. With the country’s rapid growth in population and poor healthcare services due to poverty, inadequate health personnel and facilities it is worth trying the use of mobile phone applications in diabetes management. The main aim of this study is to assess the effectiveness of the SORYOL mobile app for home management of type 2 diabetes.
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 HOME MANAGENT OF DIABETES
Anticipated trial start date 02/10/2023
Actual trial start date 06/11/2023
Anticipated date of last follow up 30/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 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
Control Group Standard hospital diabetes care Routine Clinic visits 3 monthly with health education given by attending physician as the need arises along with routine prescribed medication 12 months Health education given by attending physician as need arises along with routine prescribed medication 41 Active-Treatment of Control Group
Experimental Group SORYOL CARE APP ROUTINE CLINIC VISITS 3 MONTHLY WHILE USING THE SORYOL APP AT HOME WITH PHYSICIAN ACCESS TO HOME APP RECORDS IN BETWEEN CLINIC VISITS ALONG WITH ROUTINE MEDICATION 12 MONTHS FULL PREMIUM SUBSCRIPTION ACCESS INCLUDING DIABETES EDUCATION IN ENGLISH + 2 NIGERIAN LANGUAGES, FAMILY SUPPORT OF UP TO 4 FAMILY MEMBERS ON THE APP, DAILY MEAL PLANS AND REMINDERS, MEDICATION RECORDING AND REMINDERS, HOME BLOOD SUGAR MEASUREMENT RECORDINGS, HOME BLOOD PRESSURE MEASUREMENT RECORDINGS, RECORDS OF OTHER HEALTH TESTS, ACCESS TO HOME HEALTH RECORDS BY ATTENDING PHYSICIAN AND/ HEALTH TEAM, HEALTH JOURNEY CHARTING AND DAILY SCHEDULE PLANNING 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Confirmed diagnosis of type 2 diabetes at least six months before enrolment. 2. At least 18 years of age at randomization. 3. At least one HbA1c test result ≥ 6.5% within the six months prior to enrolment. 4. Owns an android phone. 1. Presenting with acute diabetic emergency. 2. Presenting with life threatening illness. 3. Not literate in any of the SORYOL Diabetes Care App languages. 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 17/03/2023 Federal Capital Territory Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Unit, Room 10 Block A Annex, HHSS, FCTA Secretariat. No 1 Kapital Street, Area 11, Garki, Abuja Abuja 900001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hba1c value following 36 to 48 weeks of follow up week 0, week 12, week 24, week 36, week 48
Secondary Outcome 1. Proportion of participants achieving HbA1c target level of < 6.5%. week 12, week 24, week 36, week 48
Secondary Outcome 2. Proportion of participants achieving medication adherence > 95% week 12, week 24, week 36, week 48
Secondary Outcome 3. Proportion of participants who feel they need education and support for diabetes management at home. week 12, week 24, week 36, week 48
Secondary Outcome 4. Proportion of participants who utilize the education and support features of the SORYOL Diabetes Care App. week 12, week 24, week 36, week 48
Secondary Outcome 5. Proportion of participants who utilize the other features of the SORYOL Diabetes Care App (medication, meal plans, test recording, group chats, daily scheduling, etc). week 12, week 24, week 36, week 48
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Garki Hospital Abuja Tafawa Balewa Way Abuja 900103 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Barbara Avershima Akinbuwa Innova Health Resources Ltd, Mandys Plaza, No 4 Jonah Jang Way Makurdi Benue State 970001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Barbara Avershima Akinbuwa Innova Health Resources Ltd, Mandys Plaza, No 4 Jonah Jang way Makurdi Benue State 970001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Adamu Onu Garki Hospital, Tafawa Balewa Way, Area 8 Abuja Abuja 900103 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Barbara Akinbuwa drbarbaraakinbuwa@soryol.com +2348035865832 Innova Health Resources Ltd, Mandys Plaza, No 4 Jonah Jang way
City Postal code Country Position/Affiliation
Makurdi 970001 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Barbara Akinbuwa drbarbaraakinbuwa@soryol.com +2348035865832 Innova Health resources Ltd, Mandys Plaza, No 4 Jonah Jang way
City Postal code Country Position/Affiliation
Makurdi 970001 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Adamu Onu adamu.onu@gmail.com +2348034749930 Garki Hospital, Tafawa Balewa way, Area 8, Garki
City Postal code Country Position/Affiliation
Abuja 900103 Nigeria Study Statistician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A summary of the study results will be sent to study participants via Whatsapp before publication of results. Results and other data will be shared in anonymized form. Data and results may also be used in other studies, for improvement of the app as well as for educational and promotional purposes. No data with identifiable markers will be made public at any time. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Participants will get a summary of the study results latest by the end of month 15. Researchers and the general public can access anonymized study results, data and documents in the google drive provided. These will be uploaded as available during the course of the study and will remain available up to 2 years after publication of study results. Drive will be open to anyone with the link
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/drive/folders/1aREMND4QbCzVPzettArgupbOcZ1plGZc?usp=sharing 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