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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
742
Participants will receive 170 text messages in their mobile phones during twelve months.
Ignacio Ricci-Cabello
Palma de Mallorca, Balearic Islands, Spain
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.
Time frame: 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.
Time frame: Baseline and post-intervention at 12 months
Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
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.
Time frame: Baseline and post-intervention at 12 months
Health-related Quality of Life (EQ-5D-5L)
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.
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Time frame: Baseline and post-intervention at 12 months
Self-efficacy to Manage Diabetes (DSES-S)
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.
Time frame: Baseline and post-intervention at 12 months