Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
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 rel
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Malawi, South Africa
Contacts
Public ContactAndrew Farmer
Outcome results
None listed