Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Medication, Adherence, Glycaemic control, Healthy lifestyle, mHealth, SMS
Brief summary
This study aims at evaluating the feasibility 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 three 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 three months, the research assistant will contact the primary care center and the patient to arrange blood test analyses.
Interventions
DEVICEDIABE-TEXT
Participants will receive daily (from monday to friday) text messages in their mobile phones during three months.
Sponsors
Fundació d'investigació Sanitària de les Illes Balears
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients registered in the Public Health Service of the Balearic Islands * With type 2 diabetes * At least one prescription of an oral glucose-lowering drug * With results of HbA1C\>8% from 3 months prior to recruitment.
Exclusion criteria
* Younger than 18 years old * With insulin treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (HbA1C) | Baseline and post-intervention at 3 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) | Baseline and post-intervention at 3 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. |
| Enrolment or Recruitment Rate | Baseline | (Patients enroled/ Total Eligible patients) x 100 percent |
| Retention Rate | 3 months | (Patients who finish follow-up/Total recruited) x 100 percent |
Other
| Measure | Time frame | Description |
|---|---|---|
| 14-point Mediterranean Diet Adherence Screener (MEDAS-14) | Baseline and post-intervention at 3 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 MediterraneanDiet. A higher score means a higher adherence to Mediterranean diet. Results obtained through the website from the Public Health System of the Balearic Islands: https://apps.caib.es/plasalutfront/formularios/dieta/dieta.xhtml |
| Being Adherent to Physical Activity Recommendations Based on Having Moderate or High Levels of Physical Activity Resulted From the International Physical Activity Questionnaire (IPAQ) | Baseline and post-intervention at 3 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 having 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. We used the available tool from the Public Health System of the Balearic Islands: https://apps.caib.es/plasalutfront/formularios/ipaq/ipaq.xhtml |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
DIABE-TEXT: Participants will receive daily (from monday to friday) text messages in their mobile phones during three months. | 96 |
| Usual Care Participants allocated to the control group will not receive any intervention apart from usual care. | 111 |
| Total | 207 |
Baseline characteristics
| Characteristic | DIABE-TEXT | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 12 | 62 years STANDARD_DEVIATION 11 |
| HbA1c (%), Continuous | 9 Percentage of HbA1c STANDARD_DEVIATION 1 | 9.1 Percentage of HbA1c STANDARD_DEVIATION 1.3 | 9 Percentage of HbA1c STANDARD_DEVIATION 1.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 35 Participants | 37 Participants | 72 Participants |
| Sex: Female, Male Male | 61 Participants | 74 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 96 | 0 / 111 |
| 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.
Time frame: Baseline and post-intervention at 3 months
Population: The number analyzed post-intervention differs from overall number analyzed because of losses to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIABE-TEXT | Glycated Hemoglobin (HbA1C) | Baseline | 9 Percentage of HbA1c | Standard Deviation 1 |
| DIABE-TEXT | Glycated Hemoglobin (HbA1C) | Post-intervention | 7.7 Percentage of HbA1c | Standard Deviation 1.3 |
| Usual Care | Glycated Hemoglobin (HbA1C) | Baseline | 9.1 Percentage of HbA1c | Standard Deviation 1.3 |
| Usual Care | Glycated Hemoglobin (HbA1C) | Post-intervention | 7.6 Percentage of HbA1c | Standard Deviation 1.2 |
Secondary
Enrolment or Recruitment Rate
(Patients enroled/ Total Eligible patients) x 100 percent
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DIABE-TEXT | Enrolment or Recruitment Rate | 207 Participants |
Secondary
Number of Participants Classified as Adherent Based on Self-reporteAdherence 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 3 months
Population: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIABE-TEXT | Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) | Baseline | 72 Participants |
| DIABE-TEXT | Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) | Post-intervention | 73 Participants |
| Usual Care | Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) | Baseline | 76 Participants |
| Usual Care | Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) | Post-intervention | 62 Participants |
Secondary
Retention Rate
(Patients who finish follow-up/Total recruited) x 100 percent
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DIABE-TEXT | Retention Rate | 89 Participants |
| Usual Care | Retention Rate | 90 Participants |
Other Pre-specified
14-point Mediterranean Diet Adherence Screener (MEDAS-14)
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 MediterraneanDiet. A higher score means a higher adherence to Mediterranean diet. Results obtained through the website from the Public Health System of the Balearic Islands: https://apps.caib.es/plasalutfront/formularios/dieta/dieta.xhtml
Time frame: Baseline and post-intervention at 3 months
Population: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIABE-TEXT | 14-point Mediterranean Diet Adherence Screener (MEDAS-14) | Baseline | 49 Participants |
| DIABE-TEXT | 14-point Mediterranean Diet Adherence Screener (MEDAS-14) | Post-intervention | 53 Participants |
| Usual Care | 14-point Mediterranean Diet Adherence Screener (MEDAS-14) | Post-intervention | 43 Participants |
| Usual Care | 14-point Mediterranean Diet Adherence Screener (MEDAS-14) | Baseline | 55 Participants |
Other Pre-specified
Being Adherent to Physical Activity Recommendations Based on Having Moderate or High Levels of Physical Activity Resulted From the International Physical Activity Questionnaire (IPAQ)
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 having 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. We used the available tool from the Public Health System of the Balearic Islands: https://apps.caib.es/plasalutfront/formularios/ipaq/ipaq.xhtml
Time frame: Baseline and post-intervention at 3 months
Population: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIABE-TEXT | Being Adherent to Physical Activity Recommendations Based on Having Moderate or High Levels of Physical Activity Resulted From the International Physical Activity Questionnaire (IPAQ) | Baseline | 56 Participants |
| DIABE-TEXT | Being Adherent to Physical Activity Recommendations Based on Having Moderate or High Levels of Physical Activity Resulted From the International Physical Activity Questionnaire (IPAQ) | Post-intervention | 62 Participants |
| Usual Care | Being Adherent to Physical Activity Recommendations Based on Having Moderate or High Levels of Physical Activity Resulted From the International Physical Activity Questionnaire (IPAQ) | Baseline | 55 Participants |
| Usual Care | Being Adherent to Physical Activity Recommendations Based on Having Moderate or High Levels of Physical Activity Resulted From the International Physical Activity Questionnaire (IPAQ) | Post-intervention | 52 Participants |