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| ID | Type | Description | Link |
|---|---|---|---|
| IB 43/20/20 PI | Other Identifier | Research Ethics Committee of the Balearic Islands |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIABE-TEXT | Experimental | 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. |
|
| Usual care | No Intervention | Participants allocated to the control group will not receive any intervention apart from usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIABE-TEXT | Device | Participants will receive daily (from monday to friday) text messages in their mobile phones during three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and post-intervention at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ignacio Ricci-Cabello | Palma de Mallorca | Balearic Islands | 07002 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27095386 | Background | Arambepola C, Ricci-Cabello I, Manikavasagam P, Roberts N, French DP, Farmer A. The Impact of Automated Brief Messages Promoting Lifestyle Changes Delivered Via Mobile Devices to People with Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Controlled Trials. J Med Internet Res. 2016 Apr 19;18(4):e86. doi: 10.2196/jmir.5425. | |
| 26470750 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Participants allocated to the control group will not receive any intervention apart from usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number analyzed post-intervention differs from overall number analyzed because of losses to follow-up. | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline and post-intervention at 3 months |
|
3 months
All-cause mortality and serious adverse events were not assessed; therefore, the number of affected participants cannot be reported accurately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling emotionally distressed | Investigations | Systematic Assessment |
First, rather than ordering laboratory tests to measure HbA1c, we extracted this data from electronic clinical records. Second, we used an ad hoc questionnaire to measure medication adherence. Finally, although 99% of the SMS messages were successfully delivered, and 96% of the participants stated that they received and read the messages as intended, we were not able to track the number of messages actually opened by the participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rocío Zamanillo Campos | Health Research Institute of the Balearic Islands (IdISBa) | 971175897 | rocio.zamanillo@ssib.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2020 | Dec 19, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2020 | Oct 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline and post-intervention at 3 months |
| Enrolment or Recruitment Rate | (Patients enroled/ Total Eligible patients) x 100 percent | Baseline |
| Retention Rate | (Patients who finish follow-up/Total recruited) x 100 percent | 3 months |
| Baseline and post-intervention at 3 months |
| 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 | Baseline and post-intervention at 3 months |
| Farmer AJ, McSharry J, Rowbotham S, McGowan L, Ricci-Cabello I, French DP. Effects of interventions promoting monitoring of medication use and brief messaging on medication adherence for people with Type 2 diabetes: a systematic review of randomized trials. Diabet Med. 2016 May;33(5):565-79. doi: 10.1111/dme.12987. Epub 2015 Nov 17. |
| 37267809 | Derived | Zamanillo-Campos R, Fiol-deRoque MA, Serrano-Ripoll MJ, Mira-Martinez S, Ricci-Cabello I. Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial. Int J Med Inform. 2023 Aug;176:105103. doi: 10.1016/j.ijmedinf.2023.105103. Epub 2023 May 22. |
| BG001 | Usual Care | Participants allocated to the control group will not receive any intervention apart from usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| HbA1c (%), Continuous | Mean | Standard Deviation | Percentage of HbA1c |
|
| OG001 | Usual Care | Participants allocated to the control group will not receive any intervention apart from usual care. |
|
|
| 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. | The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up. | Posted | Count of Participants | Participants | Baseline and post-intervention at 3 months |
|
|
|
| Secondary | Enrolment or Recruitment Rate | (Patients enroled/ Total Eligible patients) x 100 percent | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Retention Rate | (Patients who finish follow-up/Total recruited) x 100 percent | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up. | Posted | Count of Participants | Participants | Baseline and post-intervention at 3 months |
|
|
|
| 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 | The number analyzed post-intervention differs from overall number analyzed at baseline because of lost to follow-up. | Posted | Count of Participants | Participants | Baseline and post-intervention at 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 1 |
| 96 |
| EG001 | Usual Care | Participants allocated to the control group will not receive any intervention apart from usual care. | 0 | 0 | 0 | 0 | 0 | 111 |
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| Post-intervention |
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| Post-intervention |
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| Post-intervention |
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