Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2015
INTERVENTION: 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. CONDITION: Type 2 diabetes ; Nutritional, Metabolic, Endocrine ; Non‐insulin‐dependent diabetes mellitus PRIMARY OUTCOME: 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: 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 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
Epistemonikos ID: b14bf650dc74320ef395d37c13471ea5c03efc4e
First added on: Jul 02, 2024