mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II Study) (preDIABETEXT)

Fundació d'investigació Sanitària de les Illes Balears

Status: Completed

Conditions: Prediabetic State

Treatments: Behavioral: preDIABE-TEXT; Other: Online Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05110625

SYN20/04

Details and patient eligibility

About

The aim of this study is to develop and evaluate a low intensity, multifaceted, digital health intervention to prevent T2DM based on: i) the use of a system comprising mobile health (mHealth) technology integrated with electronic health records to send tailored text messages (SMSs) promoting lifestyle changes in people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management.

Full description

The PREDIABETEXT project will involve five WorkPackages (WP). In WP1-4 we will develop and pilot-test the different components of the intervention (WP1 will develop the brief text messages targeted to patients; WP2 will adapt our existing technology system to deliver the messages; WP3 will develop an educational intervention targeted to Primary Healthcare workers, and; WP4 will pilot-test and optimise both interventions). In WP5 we will conduct a phase II, six-month, three-arm, cluster randomised, clinical trial with 42 primary care workers and 420 patients at risk of T2DM (HbA1c from 6% to 6.4% or fasting plasma glucose 110-125mg/dl, or both) registered in Primary Care centres from Mallorca. Patients will be allocated to a control (usual care) group, intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare workers). The primary outcome will be HbA1c. Secondary outcomes will include additional clinical outcomes, and physiological, behavioural and psychological outcomes.

Enrollment: 365 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

ELIGIBILITY CRITERIA FOR PRIMARY HEALTHCARE WORKERS:

We will include physicians and nurses from primary care centres in Mallorca. We will exclude those anticipating moving to a different centre during the study period.

ELIGIBILITY CRITERIA FOR PATIENTS:

Inclusion Criteria:

• Registered in the Public Health Service of the Balearic Islands
• At risk of T2DM (HbA1c from 6% to 6.4% within the last 3 months or two consecutive values of fasting plasma glucose 110-125mg/dl within the last 12 months, or both)
• With access to a mobile device able to receive text messages.

Exclusion Criteria:

• People not able to read messages in Spanish
• Patients with severe mental conditions.
• Patients on an antidiabetic medication regime
• Pregnancy: currently or during the previous 12 months
• People planning to change healthcare centre during the intervention period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 3 patient groups

Intervention A

Experimental group

Description:

Participants will receive Messaging Intervention

Treatment:

Behavioral: preDIABE-TEXT

Intervention B

Experimental group

Description:

Participants will receive messaging intervention plus online education to their primary healthcare workers

Treatment:

Other: Online Education

Behavioral: preDIABE-TEXT

Control

No Intervention group

Description:

Participants will receive usual care only, and their healthcare workers will not receive online education