Diabetes text study

• Register: ISRCTN
• Last refreshed on: 17 April 2023
• Main ID: ISRCTN10342151
• Date of registration: 11/03/2015
• Prospective Registration: No
• Primary sponsor: Kuwait University
• Public title: Diabetes text study
• Scientific title: The Diabetes And TEle-mobile Study (DATES): a randomised controlled trial of mobile health intervention to support self-management for people with type 2 diabetes
• Date of first enrolment: 01/09/2013
• Target sample size: 400
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10342151
• Study type: Interventional
• Study design: Two-arm parallel randomised controlled trial over 12 months (Treatment)
• Phase: Not Applicable

Countries of recruitment

Kuwait

Contacts

• Name: Clare Tucker

Key inclusion & exclusion criteria

Inclusion criteria: 1. Adults with poorly controlled type 2 diabetes mellitus and who are registered at Dasman Institute and in the primary care centres affiliated to Dasman. Type 2 diabetes will be defined according to current World Health Organisation criteria. Poorly controlled diabetes will be defined as having at least one HbA1c value of > 8% in the preceding 12 months and at recruitment despite standard care defined as the offer of at least 2 diabetes clinic reviews in the same time period.
2. On diet and/or oral hypoglycaemic agents and/or once daily long acting insulin where glycaemic control is monitored by the HbA1c and not by regular self monitoring of blood glucose by patient.
3. Age 18-75 years to increase the representativeness of the sample and to be inclusive of all ages.
4. Fluent in spoken Arabic or English and have a reading age in Arabic or English of a minimum age 7 years.
5. Officially resident in Kuwait.
Exclusion criteria: 1. Duration of type 2 diabetes less than 1 year as these patients are still coming to terms and adjusting to the diagnosis and the self care roles.
2. Women who are gestational or planning pregnancy as they have specialist diabetes care needs
3. People with severe mental illnesses such as psychosis, learning difficulties, dementia excluded from the medical records and by checklist from the physician.
4. People with advanced cancer or diabetes complications (renal failure as measured by ACR > 50, above ankle amputation, registered partially blind) or terminal conditions.
5. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
6. Multiple insulin doses regimens as this will increase the need for more clinical resources to provide a more intensive biofeedback service requiring more clinician support. The purpose of the M-and-M study is to test whether a stand-alone psychological intervention delivered in a virtual media with minimum clinical support can be effective as an adjunct to usual diabetes care.
7. People who do not have access to a mobile phone or the internet.
8. Individuals with another member of their household participating in the study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes

Intervention(s)

Usual care
All participants will receive usual diabetes care from the Dasman Diabetes Institute. This includes face to face clinical appointments with the diabetologist, diabetes specialist nurse and dietician, prescribing of medication, lifestyle advice and counselling using adult learning education techniques. They also receive weekly texts giving advice and information about diabetes. The usual care only group will also receive weekly text messages such as thanking them for their participation and regarding the rationale for the study.

Usual care plus DATES intervention
Participants will receive motivational text messages to support them in making diet and exercise changes. The theoretical framework underlying the text messages will be derived from motivational interviewing and cognitive behaviour theory. The messages will contain both standardized, personalized and responsive messages. The text messages will be delivered at set times as well as being responsive to certain requests (e.g. crave). Participants will also have access to a telephone hotline run by the research nurse to provide the additional clinical support that may arise from receiving frequent text messages. They will also have access to a website giving further information about self-motivation, tips on how to increase physical activity and change to a healthy diet in a culturally sensitive framework.

The key features of the intervention will be:

1. Personalising the intervention. At baseline assessment, participants will be asked to identify their top three reasons for wanting better diabetes control. Participants will be provided with prompts if they are unable to generate their own reasons. Prompts may include: for their children/family, to avoid complications (keeping sight, kidney, amputatio

Primary Outcome(s)

Difference in HbA1c from baseline to 12 months between the 2 arms

Secondary Outcome(s)

Difference from baseline to 12 months between the 2 arms in body mass index, physical activity, fasting lipids, and quality of life. We will also measure HbA1c at 6 months into the treatment to examine the rate of change in glycaemic control and to minimise attrition

Secondary ID(s)

DDI Protocol No. RA-2012-006

Source(s) of Monetary Support

Kuwait University, Dasman Institute, Kuwait

Ethics review

Status:
Approval date:
Contact:

The Dasman Diabetes Institute, Kuwait RA/049/2012, 10/06/2012

Results

• Results available: Yes
• Date Completed: 31/08/2018