mHealth Intervention to Support Diabetes Medication Adherence

Supporting People With Type 2 Diabetes in Effective Use of Their Medicine Through a System Comprising Mobile Health Technology Integrated With Clinical Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05006872

Acronym

DIABE-TEXT

Enrollment

742

Registered

2021-08-16

Start date

2021-10-06

Completion date

2023-04-30

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes, medication, adherence, glycaemic control, healthy lifestyle, mHealth, SMS

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.

Detailed description

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.

Interventions

DEVICEDIABE-TEXT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Glycated Hemoglobin (HbA1c) (%)	Baseline and post-intervention at 12 months	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.
Mean Adherence to Antidiabetic Drugs (%)	Baseline and post-intervention at 12 months	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.

Secondary

Measure	Time frame	Description
Self-efficacy to Manage Diabetes (DSES-S)	Baseline and post-intervention at 12 months	The validated scale known as diabetes management self-efficacy scale in Spanish (DSES-S) was completed at baseline and post-intervention interviews. The scales consist of 8 Likert-type 10-point items. The score for each item was the number circled. If two consecutive numbers were circled, the lower number (less self-efficacy) was coded. If the numbers were not consecutive, the item was not scored. The final score for the scale is the mean of the eight items (points). Therefore, DSES-S scores range between 1 to 10. If more than two items were missing, we did not score the scale following instructions. Higher number indicates higher self-efficacy.
Health-related Quality of Life (EQ-5D-5L)	Baseline and post-intervention at 12 months	The 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) questionnaire was completed at baseline and post-intervention interviews. The index score was calculated using STATA syntax code and values with the Spanish value set according to Ramos-Goñi JM et al. Information about the EQ-5D index, derived using a value set, can be presented in much the same way as the EQ VAS data, i.e. using measures of central tendency and dispersion, such as mean values and the SD (or standard error). If the data are skewed, the median values and the 25th and 75th percentiles could be presented. Note, when reporting index values, a maximum of three decimal places is usually sufficient. Index values can range between 0 to 1. Higher EQ-5D index scores mean better quality of life related to health status.
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	Number of participants classified as adherent based on Self-reported adherence to glucose medications was measured with a 7-items ad hoc questionnaire adapted from Chaves-Torres et al. for people with type 2 diabetes. Participants who obtained 7 points were considered adherent while the ones with \< 7 points were non-adherent.

Other

Measure	Time frame	Description
14-point Mediterranean Diet Adherence Screener (MEDAS-14)	Baseline and post-intervention at 12 months	The 14-point Mediterranean Diet Adherence Screener (MEDAS-14) questionnaire was registered at baseline and post-intervention. Participants were classified as low adherents (≤5), moderate adherents (6 to 9 points) or high adherents (≥10 points) according to the results obtained that can range between 1 to 14 points. After that, we joined moderate adherents with high adherents and tagged them as adherents to the Mediterranean Diet, while low adherents were considered non-adherents to the Mediterranean diet. Therefore, we presented the number of participants adherent to the Mediterranean Diet.
International Physical Activity Questionnaire (IPAQ)	Baseline and post-intervention at 12 months	A 6-items adapted from the short version of the International Physical Activity Questionnaire (IPAQ) (11) was registered at baseline and post-intervention. Participants were classified as having a low, moderate or high level of physical activity based on metabolic equivalent of task (METs) calculation. After that, we joined the participants that presented moderate or high level of physical activity and tagged them as adherents to Physical Activity recommendations, while low levels of Physical Activity was considered as being non-adherent to the Physical Activity Recommendations. Therefore, we presented the number of participants adherent to the Physical Activity Recommendations.

Countries

Spain

Participant flow

Participants by arm

Arm	Count
DIABE-TEXT Participants allocated to the intervention group received 167 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 also received reminders for healthcare visits, drug dispensation from the pharmacy and updated results from blood test records. DIABE-TEXT: Participants will receive 170 text messages in their mobile phones during twelve months.	371
Usual Care Participants allocated to the control group did not receive any intervention apart from usual care.	371
Total	742

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	37	31

Baseline characteristics

Characteristic	DIABE-TEXT	Usual Care	Total
Age, Continuous	65 years STANDARD_DEVIATION 10	65 years STANDARD_DEVIATION 10	65 years STANDARD_DEVIATION 10
Glycated hemoglobin (HbA1c)	8.1 Percentage of HbA1c	8.0 Percentage of HbA1c	8.1 Percentage of HbA1c
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Spain	371 participants	371 participants	742 participants
Sex: Female, Male Female	155 Participants	154 Participants	309 Participants
Sex: Female, Male Male	216 Participants	217 Participants	433 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	6 / 371	2 / 371
other Total, other adverse events	2 / 371	0 / 371
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.