Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Current interventions as of 04/01/2019:
This feasibility trial is a two-arm, individually randomised, parallel group trial aiming to recruit 200 participants across approximately 20 pr
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 04/01/2019: COHORT 1 (people with diabetes): 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, =35 years of age 3. Type 2 diabetes 4. Taking oral glucose lowering treatment, blood pressure lowering treatment or lipid lowering treatment either alone or in combination 5. Has access to a mobile phone and is able, if necessary with help (e.g. relative, friend, neighbour), to send, understand and retrieve brief SMS text-messages in the English language 6. The participant's practice is taking part in the trial COHORT 2 (health care professionals): Any health care professionals (including doctors, nurses, receptionists, practices managers and pharmacists) involved in the care of patients recruited to the trial. Previous participant inclusion criteria: COHORT 1 (people with diabetes): 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, =35 years of age 3. Type 2 diabetes 4. Taking oral glucose lowering treatment, blood pressure lowering treatment or lipid lowering treatment either alone or in combination 5. Has started one or more of these medications or had a change in one of these medications within the last three months 6. Has access to a mobile phone and is able, if necessary with help (e.g. relative, friend, neighbour), to send, understand and retrieve brief SMS text-messages in the English language 7. The participant's practice is taking part in the trial COHORT 2 (health care professionals): Any health care professionals (including doctors, nurses, receptionists, practices managers and pharmacists) involved in the care of patients recruited to the trial.
Exclusion criteria
Exclusion criteria: COHORT 1 (people with diabetes): 1. Female participant who is pregnant, within three months post-partum or planning pregnancy during the course of the trial 2. A serious medical condition that, in the opinion of the investigator makes them ineligible 3. Insulin treatment without also concomitant use of oral glucose lowering treatment 4. Another person in the household already participates in the trial 5. Patient has been admitted to hospital within the last three months for hyper- or hypoglycaemia (self-report) COHORT 2 (health care professionals): No exclusions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant recruitment to trial and willingness to be randomised. Outcome measure: Recruitment against planned recruitment rates. Number of people showing an interest and not proceeding or those who withdraw from the control group and give a reason; Timepoint(s): End of recruitment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The feasibility of collection of clinical measurement data for the proposed 15-month clinical trial, with particular interest in 15 months prior to trial entry or following trial entry measurement collection of participant’s HbA1c, systolic blood pressure and cholesterol. Outcome measure: Completeness of data collection of HbA1c, systolic blood pressure and total to HDL cholesterol ratio; Timepoint(s): End of follow-up period 2. The willingness of participants to be followed up over the 26-week period post randomisation. Outcome measure: Retention and follow-up rates; Timepoint(s): End of follow-up period 3. The collection of prescribing data on trial participants. Outcome measure: Proportion of medication possession ratio for glucose, blood pressure and lipid lowering medication obtainable; Timepoint(s): End of follow-up period 4. The collection of self-reported questionnaire data. Outcome measure: Proportion of completed self-reported measures; Timepoint(s): End of follow-up period 5. The feasibility and acceptability of the intervention for patients and healthcare professionals (including general practitioners, nurses, receptionists and pharmacists). Outcome measure: Data obtained through focus groups/qualitative interviews with patients and recruiting healthcare staff; Timepoint(s): Baseline and end of follow-up for patients and throughout the trial period for healthcare staff 6. The mechanisms of action of brief health related messages on self-reported adherence. Outcome measure: Change in quantitative process measures and relationship between changes in these measures and self-reported adherence; Timepoint(s): End of follow up period qualitative interviews/survey/telephone contacts with trial participants 7. The feasibility and acceptability of self-completion of the resource use questionnaire. Outcome measure: Proportion of completed resource use questionnaire; | — |
Countries
England, United Kingdom
Outcome results
None listed