DIABE-TEXT: mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: DIABE-TEXT
Participants will receive daily (from monday to friday) text messages in their mobile phones during three months.
|
| No Intervention: Usual care Participants allocated to the control group will not receive any intervention apart from usual care. |
Outcome Measures
Primary Outcome Measures
- Glycated Hemoglobin (HbA1C) [Baseline]
- Glycated Hemoglobin (HbA1C) [3 months]
Secondary Outcome Measures
- Adherence to oral antidiabetic medication (7 items ad hoc questionnaire) [Baseline]
7 points = adherent; <7 points = non-adherent
- Adherence to oral antidiabetic medication (7 items ad hoc questionnaire) [3 months]
7 points = adherent; <7 points = 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 Outcome Measures
- 14-point Mediterranean diet adherence screener (MEDAS-14) [Baseline]
The score range from 0 to 14. A higher score means a higher adherence to Mediterranean diet. We classified participants as low adherents (≤5), moderate adherents (6-9) or high adherents (≥10).
- 14-point Mediterranean diet adherence screener (MEDAS-14) [3 months]
The score range from 0 to 14. A higher score means a higher adherence to Mediterranean diet. We classified participants as low adherents (≤5), moderate adherents (6-9) or high adherents (≥10).
- International Physical Activity Questionnaire (IPAQ) [Baseline]
6-items adapted from the short version of the IPAQ by the Public Health System of the Balearic Islands: https://apps.caib.es/plasalutfront/formularios/ipaq/ipaq.xhtml Result options are: low, moderate or high level of physical activity
- International Physical Activity Questionnaire (IPAQ) [3 months]
6-items adapted from the short version of the IPAQ by the Public Health System of the Balearic Islands: https://apps.caib.es/plasalutfront/formularios/ipaq/ipaq.xhtml Result options are: low, moderate or high level of physical activity
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ignacio Ricci-Cabello | Palma De Mallorca | Balearic Islands | Spain | 07002 |
Sponsors and Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- RTI2018-096935-A-I00_pilot
- IB 43/20/20 PI