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Trial record 1 of 1 for:    NCT04738591
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mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study) (DIABE-TEXT)

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ClinicalTrials.gov Identifier: NCT04738591
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears

Study Description
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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
Diabetes Mellitus, Type 2 Device: DIABE-TEXT Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 30, 2020
Actual Primary Completion Date : April 18, 2021
Actual Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Glycated Hemoglobin (HbA1C) [ Time Frame: Baseline ]
  2. Glycated Hemoglobin (HbA1C) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adherence to oral antidiabetic medication (7 items ad hoc questionnaire) [ Time Frame: Baseline ]
    7 points = adherent; <7 points = non-adherent

  2. Adherence to oral antidiabetic medication (7 items ad hoc questionnaire) [ Time Frame: 3 months ]
    7 points = adherent; <7 points = non-adherent

  3. Enrolment or recruitment rate [ Time Frame: Baseline ]
    (Patients enroled/ Total Eligible patients) x 100 percent

  4. Retention rate [ Time Frame: 3 months ]
    (Patients who finish follow-up/Total recruited) x 100 percent


Other Outcome Measures:
  1. 14-point Mediterranean diet adherence screener (MEDAS-14) [ Time Frame: 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).

  2. 14-point Mediterranean diet adherence screener (MEDAS-14) [ Time Frame: 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).

  3. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 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

  4. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738591


Locations
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Spain
Ignacio Ricci-Cabello
Palma De Mallorca, Balearic Islands, Spain, 07002
Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
More Information
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Publications:

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Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier: NCT04738591    
Other Study ID Numbers: RTI2018-096935-A-I00_pilot
IB 43/20/20 PI ( Other Identifier: Research Ethics Committee of the Balearic Islands )
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació d'investigació Sanitària de les Illes Balears:
Diabetes
Medication
Adherence
Glycaemic control
 Healthy lifestyle
mHealth
SMS
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases