Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes
NCT ID: NCT05924516
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-02-29
2024-06-30
Brief Summary
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The digital health intervention is designed to be used for approximately 3 months. The study will enroll 150 participants (75 in control group and 75 in experimental group) who are patients with type 2 diabetes. There will be educational contents and personalized motivational messages through the Adhera Health Recommender System.
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Detailed Description
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This is a clinical trial with 75 participants in the experimental intervention group and 75 in the control group, which will be carried out in 3 Primary Care Health centers in the City of Xalapa Veracruz, called Marabroto Center, Revolution Center and Miguel Alemán Center.
The researchers will focus on evaluating the main study variables to determine the changes in the indicators in glycosylated hemoglobin, total cholesterol, triglycerides, blood pressure, BMI, waist circumference and use of coping strategies.
The efficacy of the digital intervention will be measured in 2 ways: 1) Through the analysis of each of the study variables, where its decrease or increase represents that it was effective for the control of each indicator analyzed individually, and 2) Through the binary logistic regression model where all the variables of the study as a whole are analyzed and it is determined if the digital intervention had a global efficacy.
We believe that since it is a multifactorial disease, different variables that intervene in the complications of diabetes mellitus should be studied and not exclusively one single primary endpoint.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Control Group: Standard Treatment
No interventions assigned to this group
Experimental Group
Experimental Group: Standard Treatment + Adhera® Fatigue Digital Program
Adhera® Fatigue Digital Program
The Adhera® Fatigue Digital Program is delivered via a mobile application and includes personalized educational and interactive content. The program is designed to support the wellbeing of people living with type 2 diabetes, including self-management education and support. This also includes a focus on diabetes-related fatigue.
Interventions
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Adhera® Fatigue Digital Program
The Adhera® Fatigue Digital Program is delivered via a mobile application and includes personalized educational and interactive content. The program is designed to support the wellbeing of people living with type 2 diabetes, including self-management education and support. This also includes a focus on diabetes-related fatigue.
Eligibility Criteria
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Inclusion Criteria
* Patients with smartphone and cell number.
* Participants must agree on sharing data from their clinical record.
* Participants must sign an informed consent.
* Participants must be willing to and install the mobile solution of the study.
Exclusion Criteria
* Patients with type 1 diabetes mellitus, MODY (Maturity Onset Diabetes of the Young) and gestational diabetes.
* Patients who do not wish to participate in the study.
18 Years
ALL
No
Sponsors
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Adhera Health, Inc.
INDUSTRY
Maria del Carmen Gogeascoechea Trejo
OTHER
Responsible Party
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Maria del Carmen Gogeascoechea Trejo
PhD on Sciences Health
Principal Investigators
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María del Carmen Gogeascoechea Trejo, PhD
Role: STUDY_DIRECTOR
Universidad Veracruzana
Locations
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Clínic "José A. Maraboto" Street Santiago Bonilla 85
Xalapa, Veracruz, Mexico
Clinic "Revolución" Street Valentín Canalizó, 12
Xalapa, Veracruz, Mexico
Clinic "Miguel Alemán" Avenue Miguel Alemán 107
Xalapa, Veracruz, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Kim EK, Kwak SH, Jung HS, Koo BK, Moon MK, Lim S, Jang HC, Park KS, Cho YM. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care. 2019 Jan;42(1):3-9. doi: 10.2337/dc17-2197. Epub 2018 Oct 30.
Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.
Brown JB, Ramaiya K, Besancon S, Rheeder P, Tassou CM, Mbanya JC, Kissimova-Skarbek K, Njenga EW, Muchemi EW, Wanjiru HK, Schneider E. Use of medical services and medicines attributable to diabetes in Sub-Saharan Africa. PLoS One. 2014 Sep 12;9(9):e106716. doi: 10.1371/journal.pone.0106716. eCollection 2014.
Cano Garcia FJ, Rodriguez Franco L, Garcia Martinez J. Spanish version of the Coping Strategies Inventory. Actas Esp Psiquiatr. 2007 Jan-Feb;35(1):29-39.
Other Identifiers
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U1111-1284-0047
Identifier Type: -
Identifier Source: org_study_id
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