mHealth Intervention to Support Diabetes Medication Adherence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2023-04-30

Brief Summary

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This study aims at evaluating the effectiveness of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.

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Detailed Description

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A list of patients registered in primary care centers of the Balearic Islands and potentially meeting the eligibility criteria will be obtained from electronic health records (EHRs). A research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. All eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. Participants will be randomly allocated using a computer-generated randomization sequence. All participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. In addition, the intervention group will receive the text messaging intervention. Control participants will receive usual care only.

After twelve months of follow-up, all participants will complete post-intervention assessments via phone interview. Data on glycemic control (HbA1c) at baseline and post-intervention will be extracted from EHRs, as according to the protocol used for primary care providers in the Balearic Islands, patients with poor glycemic control (HbA1c \>8% ) must request an HbA1c determination every six months. Results of the most recent determination will be extracted from electronic medical records. For those patients with no recorded HbA1c within the previous four months, the research assistant will contact the primary care center to arrange blood test analyses.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Healthcare providers (doctors and nurses from the participants' health centres, do not know if their patients are participating in the study nor the group (intervention vs control) they are. Just if a patient ask them for more information related to the study or text messages, they will know about it. Also, the interviewers that evaluate and register participants data are masked until randomization. After 12 months of follow-up, the interviewers will be masked before post-intervention evaluation. The primary outcome HbA1c is an objective measure and assessors of this outcome will be blinded to treatment allocation.

Study Groups

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DIABE-TEXT

Participants allocated to the intervention group will receive text messages in their mobile phones with content about diabetes management, general information about diabetes, medicines, diet and physical activity recommendations and motivational prompts to engage participants in a healthy lifestyle and a good adherence to medication plan. They will also receive reminders for healthcare visits, drug dispensation from the pharmacy and updated results from blood test records.

Group Type EXPERIMENTAL

DIABE-TEXT

Intervention Type DEVICE

Participants will receive 170 text messages in their mobile phones during twelve months.

Usual care

Participants allocated to the control group will not receive any intervention apart from usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DIABE-TEXT

Participants will receive 170 text messages in their mobile phones during twelve months.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients registered in the Public Health Service of the Balearic Islands
* With type 2 diabetes
* At least one prescription of a glucose-lowering drug
* With results of HbA1c\>8% from 6 months prior to recruitment

Exclusion Criteria

* Younger than 18 years old
* With insulin treatment
* Participating in another research study
* Not living in the Balearic Islands at some point during the study development

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No