Trial Outcomes & Findings for mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study) (NCT NCT04738591)

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

207 participants

Primary outcome timeframe

Baseline and post-intervention at 3 months

Results posted on

2025-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Usual Care Participants allocated to the control group will not receive any intervention apart from usual care.
Overall Study STARTED	96	111
Overall Study COMPLETED	89	90
Overall Study NOT COMPLETED	7	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DIABE-TEXT n=96 Participants 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.	Usual Care n=111 Participants Participants allocated to the control group will not receive any intervention apart from usual care.	Total n=207 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=96 Participants	61 years STANDARD_DEVIATION 12 • n=111 Participants	62 years STANDARD_DEVIATION 11 • n=207 Participants
Sex: Female, Male Female	35 Participants n=96 Participants	37 Participants n=111 Participants	72 Participants n=207 Participants
Sex: Female, Male Male	61 Participants n=96 Participants	74 Participants n=111 Participants	135 Participants n=207 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
HbA1c (%), Continuous	9 Percentage of HbA1c STANDARD_DEVIATION 1 • n=96 Participants	9.1 Percentage of HbA1c STANDARD_DEVIATION 1.3 • n=111 Participants	9 Percentage of HbA1c STANDARD_DEVIATION 1.2 • n=207 Participants

PRIMARY outcome

Timeframe: Baseline and post-intervention at 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	DIABE-TEXT n=96 Participants 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.	Usual Care n=111 Participants Participants allocated to the control group will not receive any intervention apart from usual care.
Glycated Hemoglobin (HbA1C) Baseline	9 Percentage of HbA1c Standard Deviation 1	9.1 Percentage of HbA1c Standard Deviation 1.3
Glycated Hemoglobin (HbA1C) Post-intervention	7.7 Percentage of HbA1c Standard Deviation 1.3	7.6 Percentage of HbA1c Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

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

Outcome measures
Measure	DIABE-TEXT n=96 Participants 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.	Usual Care n=111 Participants Participants allocated to the control group will not receive any intervention apart from usual care.
Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) Post-intervention	73 Participants	62 Participants
Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire) Baseline	72 Participants	76 Participants

SECONDARY outcome

Timeframe: Baseline

(Patients enroled/ Total Eligible patients) x 100 percent

Outcome measures

Outcome measures
Measure	DIABE-TEXT n=444 Participants 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.	Usual Care Participants allocated to the control group will not receive any intervention apart from usual care.
Enrolment or Recruitment Rate	207 Participants	—

SECONDARY outcome

Timeframe: 3 months

(Patients who finish follow-up/Total recruited) x 100 percent

Outcome measures

Outcome measures
Measure	DIABE-TEXT n=96 Participants 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.	Usual Care n=111 Participants Participants allocated to the control group will not receive any intervention apart from usual care.
Retention Rate	89 Participants	90 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	DIABE-TEXT n=96 Participants 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.	Usual Care n=111 Participants Participants allocated to the control group will not receive any intervention apart from usual care.
14-point Mediterranean Diet Adherence Screener (MEDAS-14) Baseline	49 Participants	55 Participants
14-point Mediterranean Diet Adherence Screener (MEDAS-14) Post-intervention	53 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	DIABE-TEXT n=96 Participants 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.	Usual Care n=111 Participants Participants allocated to the control group will not receive any intervention apart from 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	56 Participants	55 Participants
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	52 Participants

Adverse Events

DIABE-TEXT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DIABE-TEXT n=96 participants at risk 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.	Usual Care n=111 participants at risk Participants allocated to the control group will not receive any intervention apart from usual care.
Investigations Feeling emotionally distressed	1.0% 1/96 • Number of events 1 • 3 months All-cause mortality and serious adverse events were not assessed; therefore, the number of affected participants cannot be reported accurately.	0.00% 0/111 • 3 months All-cause mortality and serious adverse events were not assessed; therefore, the number of affected participants cannot be reported accurately.

Additional Information

Dr. Rocío Zamanillo Campos

Health Research Institute of the Balearic Islands (IdISBa)

Phone: 971175897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place