Randomised controlled trial to test whether text message reminders sent to women with previous gestational diabetes helps improve testing for type 2 diabetes
| ISRCTN | ISRCTN13791687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13791687 |
| IRAS number | 297067 |
| Secondary identifying numbers | IRAS 297067 |
- Submission date
- 07/09/2022
- Registration date
- 10/10/2022
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
We normally test new interventions to improve health using randomised controlled trials (RCTs). These divide people into two groups, one gets the intervention and the other does not. We compare the health effects between the two groups to see if the intervention worked. Finding and including patients is usually done manually and few of those who are suitable actually take part. This makes RCTs time-consuming, and it is hard to know if the intervention will work for everyone.
Data-driven trials are RCTs within electronic medical records. This simplifies methods by automatically finding and inviting suitable patients, checking they have given their consent to take part, then randomly dividing them into two groups and giving one group the intervention. We can also reduce the burden of taking part for both patients and health workers by using data recorded in usual clinical practice to find out whether the intervention works.
We want to show we can answer clinical questions that benefit patients by running a data-driven RCT. We have found a current health problem: a lack of testing for diabetes in women who developed diabetes during pregnancy. Each year, 30,000 UK women develop diabetes during pregnancy (we call this gestational diabetes mellitus or GDM for short). It is common in ethnic minority women. Often GDM goes away after giving birth but women who had GDM are more likely to develop diabetes in the next few years. Therefore, women are advised to have yearly diabetes tests to find out and manage diabetes early before problems occur. But many women are not tested yearly so we need ways to help more get tested.
Who can participate?
Women with a previous diagnosis of gestational diabetes who have not had a test for type 2 diabetes in the past 12 months and have previously been sent a test message from their GP practice will be entered into the study. Women with a previous diagnosis of type 1 or 2 diabetes, or pregnant in the past 12 months will be excluded.
What does the study involve?
Women who are assigned to the intervention group will be sent a text message reminding them to be tested for type 2 diabetes. There will also be a link to an animation that details what the test will involve and the purpose of the test.
What are the possible benefits and risks of participating?
The wording of the text message and the animation will be produced following consultation with lay people, health professionals and researchers to make sure the information it contains is accurate, and the tone is non-coercive. We do not anticipate any risks that may harm women who take part in the trial.
Where is the study run from?
The study is run from the Institute of Applied Health Research at the University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
September 2022 to July 2023
Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Francesca Crowe
F.Crowe@bham.ac.uk
Contact information
Principal Investigator
Institute of Applied Health Research
University of Birmingham
Pritchatts Road
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0003-4026-1726 |
|---|---|
| Phone | +44 7733450666 |
| F.Crowe@bham.ac.uk |
Study information
| Study design | Multicentre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | impRoving testing for cardiometabolic diseases in women with previous gestational diabetes mellitus: an exemplar study on implementation and evaluation of a novel dAta-DrIven rANdomised clinical Trial platform in primary care (RADIANT) |
| Study acronym | RADIANT |
| Study hypothesis | We aim to conduct a data-driven randomised controlled trial (RCT) to demonstrate the capacity of NHS data to answer an important clinical question that benefits patients. We will test this by developing an SMS and animation intervention for women with previous GDM to assess whether it increases testing for T2DM and cardiometabolic disease risk factors in primary care compared to usual care. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Testing for type 2 diabetes in women with previous gestational diabetes |
| Intervention | Randomisation will be done using the randomise function within Outcomes Manager (computer software that is used in GP practices). Randomisation will be stratified by practice. The GP will not be aware of the upcoming allocation and this randomisation process can only occur once for each participating practice. Intervention: women will be sent a text message and link to an animation explaining what the procedure is for testing for type 2 diabetes Control: women will receive the usual care as per the National Institute of Health and Care Excellence (NICE) guidelines The text message will only be sent to each of the women in the intervention group on one occasion (at randomisation). The researchers will follow women up for 3 months post-randomisation to assess whether they have a test for type 2 diabetes. |
| Intervention type | Behavioural |
| Primary outcome measure | Blood test for type 2 diabetes (glycosylated haemoglobin (HbA1c), fasting blood glucose or a 2-hour oral glucose tolerance test) in their primary care records 3 months after randomisation |
| Secondary outcome measures | Measurement of blood pressure, body mass index or blood lipids (total, LDL and HDL cholesterol) in primary care records 3 months after randomisation |
| Overall study start date | 07/09/2022 |
| Overall study end date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 600 |
| Participant inclusion criteria | Women with a previous diagnosis of gestational diabetes |
| Participant exclusion criteria | 1. Previous diagnosis of type 1 or 2 diabetes 2. A test of glycaemia in the past 12 months (fasting blood glucose, glycosylated haemoglobin (HbA1c) or oral glucose tolerance test), 3. Pregnant in the past 12 months. 4. GP considers them unsuitable for the RCT on clinical or social grounds |
| Recruitment start date | 01/04/2023 |
| Recruitment end date | 15/04/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor information
University/education
Pritchatts Road
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 121 414 3344 |
|---|---|
| aer-ethics@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed journal 2. Publication of results in NHS Evidence 3. Dissemination through diabetes charities 4. Study protocol and statistical analysis plan will be available when they are completed |
| IPD sharing plan | Data collected for this trial will come from routinely collected health care data that is available in THe Health Improvement Network (THIN) database. Anonymised data will be available upon application to the Scientific Review Committee of THIN. |
Editorial Notes
09/09/2022: Trial's existence confirmed by the NIHR.
