mHealth Intervention to Support Diabetes Medication Adherence
DIABE-TEXT
Supporting People With Type 2 Diabetes in Effective Use of Their Medicine Through a System Comprising Mobile Health Technology Integrated With Clinical Care
2 other identifiers
interventional
742
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedResults Posted
Study results publicly available
February 28, 2025
CompletedFebruary 28, 2025
February 1, 2022
1.5 years
August 9, 2021
April 10, 2024
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glycated Hemoglobin (HbA1c) (%)
HbA1c was extracted as percentage which is calculated following the standard formulae \[HbA1c(%)=(HbA1c(mmol/mol)+23.5)/ 10.93\] based on its concentration in blood samples. It identifies average plasma glucose concentration (1). The most recent HbA1c data registered between 6th of April and 12th of November in 2021 were extracted for all participants at baseline. At post-intervention, we extracted the most recent data which was available between 21st September 2022 and 21st February 2023.
Baseline and post-intervention at 12 months
Mean Adherence to Antidiabetic Drugs (%)
We calculated adherence in terms of medication possession ratio (MPR), defined as the number of days with treatment as medication being dispensed from the pharmacy to the patient (numerator), out of the total days of treatment prescribed by the doctor (denominator) (2): MPR = \[Days with treatment (prescription dispensed) / Days with treatment as prescribed by the doctor\] x 100 At baseline it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 6 months previous to recruitment excluding insulin. At post-intervention it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 12 months follow-up excluding insulin.
Baseline and post-intervention at 12 months
Secondary Outcomes (3)
Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
Baseline and post-intervention at 12 months
Health-related Quality of Life (EQ-5D-5L)
Baseline and post-intervention at 12 months
Self-efficacy to Manage Diabetes (DSES-S)
Baseline and post-intervention at 12 months
Other Outcomes (2)
14-point Mediterranean Diet Adherence Screener (MEDAS-14)
Baseline and post-intervention at 12 months
International Physical Activity Questionnaire (IPAQ)
Baseline and post-intervention at 12 months
Study Arms (2)
DIABE-TEXT
EXPERIMENTALParticipants 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.
Usual care
NO INTERVENTIONParticipants allocated to the control group will not receive any intervention apart from usual care.
Interventions
Participants will receive 170 text messages in their mobile phones during twelve months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ignacio Ricci-Cabello
Palma de Mallorca, Balearic Islands, 07002, Spain
Related Publications (1)
Zamanillo-Campos R, Fiol-DeRoque MA, Serrano-Ripoll MJ, Mira-Martinez S, Llobera-Canaves J, Taltavull-Aparicio JM, Leiva-Rus A, Ripoll-Amengual J, Angullo-Martinez E, Socias-Buades IM, Masmiquel-Comas L, Konieczna J, Zaforteza-Dezcallar M, Boronat-Moreiro MA, Gervilla-Garcia E, Ricci-Cabello I. DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Jan;136:107399. doi: 10.1016/j.cct.2023.107399. Epub 2023 Nov 22.
PMID: 37995967BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Difficulties in accurately measuring participant adherence due to message comprehension uncertainties and relay through caregivers, potentially diluting intervention reach. 2. Lack of intermediate evaluations during follow-up. 3. Lack of registration of social variables.
Results Point of Contact
- Title
- Dra. Rocío Zamanillo Campos
- Organization
- Health Research Institute of the Balearic Islands
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 16, 2021
Study Start
October 6, 2021
Primary Completion
March 31, 2023
Study Completion
April 30, 2023
Last Updated
February 28, 2025
Results First Posted
February 28, 2025
Record last verified: 2022-02