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.: PACTR201810599931422 Date of Approval: 17/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of mobile phone SMS in promoting adherence to anti-diabetic therapy and glycaemic control among diabetic patients in South Africa
Official scientific title Efficacy, Acceptability and Feasibility of mHealth Technology in promoting adherence with anti-diabetic regimen among diabetic patients in Eastern Cape, South Africa
Brief summary describing the background and objectives of the trial Diabetes is a significant public health challenge with an increasing prevalence in both developed and developing countries. South Africa is not exempted from the growing burden of diabetes, even in the face of high burden of infectious diseases. Adequately controlled glycaemic status is the overall aim of all diabetes care and management, failure of which predisposes to increased risk for complications development. The presence of complications poorly affect the health-related quality of life of the patients, increases healthcare cost and impose greater burden on the already over-burdened health care system. In spite of the innovative scientific discoveries and treatment modalities, glycaemic control seems to be generally sub-optimal, gloablly and in South Africa. Various reasons have been reported for this sub-optimal control, which range from poor adherence to therapy, inadequate knowledge, demographic characteristics, quality of healthcare, health facilities factors, costs amongst others. Since diabetes is chronic in nature, the importance of adequate self-management behaviour cannot be over-emphasised. mHealth technology is an emerging and cost effective measure of providing information to patients, improve their knowledge, self-care behaviour and ultimately improve disease outcome. Its effectiveness has been documented in several developed countries, with little or no study accessing its effectiveness in low-resource settings, such as Africa. Therefore, this trial aimed at determining the efficacy, acceptability and feasibility of mHealth technology (SMS) in promoting adherence to anti-diabetic therapy and glycaemic control among individuals living with diabetes in Eastern Cape, South Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SASMS4DM
Disease(s) or condition(s) being studied Diabetes mellitus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 05/03/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date 28/02/2019
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 220
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
GOO171OWA01 University of Fort Hare Research Ethics committee
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group Normal standard of care for diabetes received at the clinic, either once a month or as required 6 months standard diabetes care without sms 125 Placebo
Experimental Group Intervention group receiving SMS Daily SMS 6 months This group receive a daily SMS on diabetes, and appointment reminders for six months 125
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years and above; Diagnosed of diabetes mellitus; Have a HBA1c level of >7.0%; Receiving treatment and is in possession of a mobile phone; Able to read a SMS or have an available relative willing to assist in reading the SMS. Have psychiatric disorders, pregnant, debilitated, handicapped in any form such that obtaining anthropometric measurements will be difficult cognitive impairment or any form of impairment that will hinder the use of cell phones. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 13/11/2017 University of Fort Hare Research ethics Committee
Ethics Committee Address
Street address City Postal code Country
5, OXFORD STREET, East London, South Africa EAST LONDON 5271 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in mean average of three fasting blood glucose readings Baseline and 6 months post intervention
Secondary Outcome Change in health-related quality of life, diabetes knowledge, diabetes self-management behaviour, adherence to treatment and appointments At baseline and 6 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fezeka Clinic Nu 13, Mdantsane Mdantsane South Africa
Luyolo clinic NU 9 Mdantsane East London South Africa
Nontyatyambo Community Healthcare Centre Nu 1, Mdantsane East London South Africa
Butterworth Gateway Clinic Butterworth Butterworth South Africa
Ndabakazi Primary health clinic Ndabakazi Buttterworth South Africa
Nqamakwe community healthcare centre Nqamakwe Nqamakwe Butterworth South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 4, Lake street, Vincent EAST LONDON 5247 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Fort Hare 5, OXFORD STREET EAST LONDON 5271 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Daniel Ter Goon 5, OXFORD STREET EAST LONDON 5271 South Africa
Dr Vincent Oladele Adeniyi 4, Lake street, Vincent EAST LONDON 5247 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eyitayo Omolara Owolabi owolabiomolara101@gmail.com +27731590262 4, Lake street, Vincent
City Postal code Country Position/Affiliation
EAST LONDON 5247 South Africa Doctoral candidate at the Department of Nursing Science, University of Fort Hare
Role Name Email Phone Street address
Public Enquiries EYITAYO OMOLARA OWOLABI owolabiomolara101@gmail.com +27731590262 5, OXFORD STREET
City Postal code Country Position/Affiliation
EAST LONDON 5271 South Africa
Role Name Email Phone Street address
Scientific Enquiries EYITAYO OMOLARA OWOLABI owolabiomolara101@gmail.com +27731590262 5, OXFORD STREET
City Postal code Country Position/Affiliation
EAST LONDON 5271 South Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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