mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study)

Diabetes Mellitus, Type 2 Clinical Trial

— DIABE-TEXT  

Official title:

Feasibility Study Through a Phase II Randomized Clinical Trial of an Intervention Based on Short Message System (SMS) to Promote Adherence to Antidiabetic Medication and Healthy Lifestyles in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738591
• Other study ID #: RTI2018-096935-A-I00_pilot
• Secondary ID: IB 43/20/20 PI
• Status: Completed
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: October 2020
• Source: Fundació d'investigació Sanitària de les Illes Balears
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 28, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• DIABE-TEXT
Participants will receive daily (from monday to friday) text messages in their mobile phones during three months.

Locations

Country	Name	City	State
Spain	Ignacio Ricci-Cabello	Palma De Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	14-point Mediterranean diet adherence screener (MEDAS-14)	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).	Baseline
Other	14-point Mediterranean diet adherence screener (MEDAS-14)	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).	3 months
Other	International Physical Activity Questionnaire (IPAQ)	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	Baseline
Other	International Physical Activity Questionnaire (IPAQ)	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	3 months
Primary	Glycated Hemoglobin (HbA1C)		Baseline
Primary	Glycated Hemoglobin (HbA1C)		3 months
Secondary	Adherence to oral antidiabetic medication (7 items ad hoc questionnaire)	7 points = adherent; <7 points = non-adherent	Baseline
Secondary	Adherence to oral antidiabetic medication (7 items ad hoc questionnaire)	7 points = adherent; <7 points = non-adherent	3 months
Secondary	Enrolment or recruitment rate	(Patients enroled/ Total Eligible patients) x 100 percent	Baseline
Secondary	Retention rate	(Patients who finish follow-up/Total recruited) x 100 percent	3 months