SMS supporting treatment for people with type 2 diabetes

• Register: ISRCTN
• Last refreshed on: 26 September 2022
• Main ID: ISRCTN70768808
• Date of registration: 03/08/2015
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: SMS supporting treatment for people with type 2 diabetes
• Scientific title: Mobile phone text-messaging to support treatment for people with type 2 diabetes in sub-Saharan Africa: a pragmatic individually randomised trial
• Date of first enrolment: 01/10/2016
• Target sample size: 1065
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN70768808
• Study type: Interventional
• Study design: Individually randomized controlled two-arm trial stratified by clinical centre (Treatment)
• Phase: Not Applicable

Countries of recruitment

Malawi, South Africa

Contacts

• Name: Andrew Farmer

• Name: Andrew Farmer

Key inclusion & exclusion criteria

Inclusion criteria:
1. Participant is willing and able to give informed consent for participation in the study
2. Able to communicate in one of the predominant official languages spoken in the Western Cape (Cape Town) and Gauteng (Johannesburg) provinces (e.g. English, Afrikaans, isiXhosa, isiZulu and Sesotho), in South Africa and in Malawi, English or the Chichewa language
3. Male or female, aged 18 years of above
4. A diagnosis of type 2 diabetes
5. Taking oral glucose lowering treatment
6. Has access to a mobile-phone (shared access is allowed with permission of phone owner)
7. Knows how to use SMS (it is okay if participant needs help to send or retrieve SMS)
8. Currently lives in the community served by the clinic and plans to live there for the next 18 months

Exclusion criteria:
1. Within three months of a hospital admission for hyperglycaemia or hypoglycaemia
2. Pregnant or within three months post-partum by self-report or with plans to become pregnant in the next 12 months
3. A terminal medical condition
4. Another member of the household already recruited to the trial
5. Participation in the formative work for the intervention


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Intervention(s)

The trial intervention is mobile phone short message service (SMS) texts. We will allocate patients using a randomly generated assignment plan to receive either informative messages, or non-health related messages. Trial participants allocated to the intervention group will be assigned to receive culturally appropriate text messages including motivational, educational and prompts (reminders) about medication collection with timing guided by the information collected about all participants at baseline visit, from clinic and from pharmacy attendance. Trial participants allocated to the usual care group will receive only non-informational text messages (for example messages thanking the participant for taking part in the study, and a message on their birthday) alongside usual care. Participants allocated to the usual care group, along with all clinic attendees, attendance recorded, but with no further actions relating to the randomly allocated intervention occurring. We will use a remote web-based randomisation programme for time since diagnosis, age, gender and trial site. Randomisation is carried out remotely and independently of the clinic and local research staff.

Primary Outcome(s)

Current primary outcome measure as of 11/10/2016 (methods and timepoints of measurement added 26/10/2017):
Change in HbA1c, measured with International Federation of Clinical Chemistry calibrated analyzers linked to a quality assurance scheme from baseline to one year

Previous primary outcome measure (methods and timepoints of measurement added 26/10/2017):
Change in HbA1c and the proportion of patients collecting 80% or greater of their agreed diabetes related medication derived from routine clinic data

Secondary Outcome(s)

Current secondary outcome measures as of 11/10/2016:
1. The proportion of patients collecting =80% of their agreed diabetes related medication derived from routine clinic data from baseline to one year
2. Change in systolic blood pressure, measured with valid oscillometric device from baseline to one year
3. Changes in lipids, measured with a calibrated analyzer linked to a quality assurance scheme from baseline to one year
4. A combined measure of cardiovascular risk based on HbA1c, lipids and systolic blood pressure measured from baseline to one year
5. The proportion of participants reaching treatment goals (with HbA1c<8% and systolic BP<140mmHg) at one year
6. Change in self-reported measures of health status, measured with the EQ5D-5L self-report measure from baseline to one year
7. Changes in medication taking, measured with a validated, self-report questionnaire from baseline to one year
8. Changes in eating and physical activity, measured with an 8-item 8-point Likert self-report scale from baseline to one year
9. Change in satisfaction with health care, measured with an eleven-item scale, 7-point Likert self-report scale from baseline to one year

Previous secondary outcome measures:
1. Change in systolic blood pressure
2. The proportion of the participants reaching treatment goals (with HbA1c<8% and systolic BP<140mmHg.)
3. Changes in self reported measures of health status
4. Self reported medication taking, eating and physical activity
5. Satisfaction with health care

Secondary ID(s)

MRC Grant Ref: MR/M016498/1

Source(s) of Monetary Support

Global Alliance for Chronic Disease in partnership with the UK Medical Research Council

Ethics review

Status:
Approval date:
Contact:

1. Oxford Tropical Research Ethics Committee - OxTREC, 10/04/2015, ref: 22-15 2. University of Cape Town Human Research Ethics Committee, 22/05/2015, ref: 126/2015 3. University of the Witwatersrand Human Research Ethics Committee (Medical), 08/06/2015, ref:14/49 4. Malawi NHSRC, 08/09/2015, #15/7/1425

Results

• Results available: Yes
• Date Completed: 01/04/2019