Trial Outcomes & Findings for mHealth Intervention to Support Diabetes Medication Adherence (NCT NCT05006872)
NCT ID: NCT05006872
Last Updated: 2025-02-28
Results Overview
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.
COMPLETED
NA
742 participants
Baseline and post-intervention at 12 months
2025-02-28
Participant Flow
Participant milestones
| Measure |
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.
|
Usual Care
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
371
|
371
|
|
Overall Study
COMPLETED
|
334
|
340
|
|
Overall Study
NOT COMPLETED
|
37
|
31
|
Reasons for withdrawal
| Measure |
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.
|
Usual Care
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
31
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
Total
n=742 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
65 years
STANDARD_DEVIATION 10 • n=371 Participants
|
65 years
STANDARD_DEVIATION 10 • n=371 Participants
|
65 years
STANDARD_DEVIATION 10 • n=742 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=371 Participants
|
154 Participants
n=371 Participants
|
309 Participants
n=742 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=371 Participants
|
217 Participants
n=371 Participants
|
433 Participants
n=742 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
371 participants
n=371 Participants
|
371 participants
n=371 Participants
|
742 participants
n=742 Participants
|
|
Glycated hemoglobin (HbA1c)
|
8.1 Percentage of HbA1c
n=371 Participants
|
8.0 Percentage of HbA1c
n=371 Participants
|
8.1 Percentage of HbA1c
n=742 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-intervention at 12 monthsPopulation: The number analyzed post-intervention differs from overall number analyzed because of losses to follow-up.
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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Glycated Hemoglobin (HbA1c) (%)
Baseline
|
8.1 Percentage of HbA1c
Interval 7.7 to 8.7
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8.0 Percentage of HbA1c
Interval 7.6 to 8.8
|
|
Glycated Hemoglobin (HbA1c) (%)
Post-intervention
|
7.5 Percentage of HbA1c
Interval 6.7 to 8.2
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7.4 Percentage of HbA1c
Interval 6.7 to 8.3
|
PRIMARY outcome
Timeframe: Baseline and post-intervention at 12 monthsWe 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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Mean Adherence to Antidiabetic Drugs (%)
Baseline
|
95.1 Medication possession ratio (percentage)
Interval 81.8 to 99.3
|
96.2 Medication possession ratio (percentage)
Interval 83.1 to 99.3
|
|
Mean Adherence to Antidiabetic Drugs (%)
Post-intervention
|
90.4 Medication possession ratio (percentage)
Interval 76.2 to 97.7
|
91.0 Medication possession ratio (percentage)
Interval 73.6 to 97.8
|
SECONDARY outcome
Timeframe: Baseline and post-intervention at 12 monthsPopulation: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
Baseline
|
205 Participants
|
194 Participants
|
|
Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
Post-intervention
|
220 Participants
|
197 Participants
|
SECONDARY outcome
Timeframe: Baseline and post-intervention at 12 monthsPopulation: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Health-related Quality of Life (EQ-5D-5L)
Baseline
|
0.93 score on a scale
Interval 0.88 to 1.0
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0.93 score on a scale
Interval 0.89 to 1.0
|
|
Health-related Quality of Life (EQ-5D-5L)
Post-intervention
|
1 score on a scale
Interval 0.92 to 1.0
|
0.97 score on a scale
Interval 0.89 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and post-intervention at 12 monthsPopulation: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Self-efficacy to Manage Diabetes (DSES-S)
Baseline
|
6.9 score on a scale
Interval 5.8 to 8.0
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6.9 score on a scale
Interval 5.9 to 7.9
|
|
Self-efficacy to Manage Diabetes (DSES-S)
Post-intervention
|
8.6 score on a scale
Interval 7.4 to 9.3
|
8.0 score on a scale
Interval 6.6 to 8.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and post-intervention at 12 monthsPopulation: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
14-point Mediterranean Diet Adherence Screener (MEDAS-14)
Baseline
|
271 Participants
|
281 Participants
|
|
14-point Mediterranean Diet Adherence Screener (MEDAS-14)
Post-intervention
|
171 Participants
|
169 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and post-intervention at 12 monthsPopulation: The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up.
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.
Outcome measures
| Measure |
DIABE-TEXT
n=371 Participants
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.
|
Usual Care
n=371 Participants
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ)
Baseline
|
240 Participants
|
245 Participants
|
|
International Physical Activity Questionnaire (IPAQ)
Post-intervention
|
171 Participants
|
194 Participants
|
Adverse Events
DIABE-TEXT
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DIABE-TEXT
n=371 participants at risk
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.
|
Usual Care
n=371 participants at risk
Participants allocated to the control group did not receive any intervention apart from usual care.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.54%
2/371 • Number of events 2 • Adverse event data was collected at 12-months post-intervention
Serious adverse events were not assessed; therefore, the number of affected participants cannot be reported accurately.
|
0.00%
0/371 • Adverse event data was collected at 12-months post-intervention
Serious adverse events were not assessed; therefore, the number of affected participants cannot be reported accurately.
|
Additional Information
Dra. Rocío Zamanillo Campos
Health Research Institute of the Balearic Islands
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place