mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study)

NCT04738591 | Completed Results

• 2 other identifiers: RTI2018-096935-A-I00_pilotIB 43/20/20 PI
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Medication; Adherence; Glycaemic control; Healthy lifestyle; mHealth; SMS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)

  Baseline and post-intervention at 3 months

• Enrolment or Recruitment Rate

  Baseline

• Retention Rate

  3 months

Other Outcomes (2)

• 14-point Mediterranean Diet Adherence Screener (MEDAS-14)

  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)

  Baseline and post-intervention at 3 months

Study Arms (2)

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.

Device: DIABE-TEXT

Usual care

NO INTERVENTION

Participants allocated to the control group will not receive any intervention apart from usual care.

Interventions

DIABE-TEXT DEVICE

Participants will receive daily (from monday to friday) text messages in their mobile phones during three months.

DIABE-TEXT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years old
• With insulin treatment.

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead

Study Sites (1)

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, 07002, Spain

Location

Related Publications (3)

• 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.

  PMID: 27095386 BACKGROUND

• 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.

  PMID: 26470750 BACKGROUND

• 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.

  PMID: 37267809 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Rocío Zamanillo Campos
• Organization: Health Research Institute of the Balearic Islands (IdISBa)

rocio.zamanillo@ssib.es

971175897

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 4, 2021
• Study Start: December 30, 2020
• Primary Completion: April 18, 2021
• Study Completion: June 28, 2021
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2020-10

Locations

ES (1)