Clinical trial NCT05924516: Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes
Official title: Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Digital Interventions, mHealth, fatigue, behavioral
Lead sponsor: Universidad Veracruzana
Sponsor class: OTHER
Collaborators: name: Adhera Health, Inc.
First posted: 2023-06-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be enrolled in two groups: control and experimental. Participants in the control group will continue with standard treatment, meanwhile participants in the experimental group will continue with standard treatment and will be enrolled in the digital intervention for 3 months.
Primary purpose: TREATMENT

Brief summary: This study aims to perform a digital intervention in patients with type 2 diabetes to analyze the efficacy of the digital intervention Adhera® Fatigue Digital Program in order to improve diabetes self-management and improve clinical outcomes, including chronic condition-related fatigue. This will be done through a randomized clinical trial in 3 of the main health centers in the city of Xalapa, Veracruz, Mexico.

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.

Detailed description: Adhera® Fatigue Digital Program (or AFDP) T2D adaptation is a digital health program based on behavioral and emotional change techniques that provides support to patients with type 2 diabetes mellitus. The digital health solution is designed to be used for a period of 3 months and includes a mobile application that provides educational content and sends messages about 10 diabetes mellitus care areas with the aim of improving the quality of life of patients and therefore avoiding the occurrence of complications associated with the disease.

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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with type 2 diabetes mellitus diagnosed and treated in selected urban health centers of the Sanitary Jurisdiction V of Xalapa, Ver.
* 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:

* Candidates without a smartphone or not being able to interact with it.
* 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.

Primary outcomes:
measure: Glycosylated Hemoglobin (Hb1Ac)
timeFrame: Baseline
measure: Glycosylated hemoglobin (Hb1Ac)
timeFrame: Month 3
measure: Triglycerides
timeFrame: Baseline
measure: Triglycerides
timeFrame: Month 3
measure: Total Cholesterol
timeFrame: Baseline
measure: Total Cholesterol
timeFrame: Month 3
measure: Body Mass Index
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Month 3
measure: Blood Pressure
timeFrame: Baseline
measure: Blood Pressure
timeFrame: Month 3
measure: Abdominal Perimeter
timeFrame: Baseline
measure: Abdominal Perimeter
timeFrame: Month 3
measure: Use of coping strategies
timeFrame: Baseline
measure: Use of coping strategies
timeFrame: Month 3
Secondary outcomes:
measure: Use of health services
timeFrame: Baseline
measure: Use of health services
timeFrame: Month 3
measure: Usability
timeFrame: Month 3
Other outcomes:
measure: Energy level
timeFrame: From week 1 to week 12, every two days
Locations:
city: Xalapa
country: Mexico
facility: Clínic "José A. Maraboto" Street Santiago Bonilla 85
state: Veracruz
city: Xalapa
country: Mexico
facility: Clinic "Revolución" Street Valentín Canalizó, 12
state: Veracruz
city: Xalapa
country: Mexico
facility: Clinic "Miguel Alemán" Avenue Miguel Alemán 107
state: Veracruz
Study officials:
affiliation: Universidad Veracruzana
name: María del Carmen Gogeascoechea Trejo, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.