Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes

Diabetes Mellitus Type 2 Clinical Trial

— DIAVERA  

Official title:

Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05924516
• Other study ID #: U1111-1284-0047
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Universidad Veracruzana
• Contact: Oscar Rodriguez Montes, MsC
• Phone: +522281103876
• Email: oscrodriguez[@]uv.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Mexico	Clínic "José A. Maraboto" Street Santiago Bonilla 85	Xalapa	Veracruz
Mexico	Clinic "Miguel Alemán" Avenue Miguel Alemán 107	Xalapa	Veracruz
Mexico	Clinic "Revolución" Street Valentín Canalizó, 12	Xalapa	Veracruz

Sponsors (2)

Lead Sponsor	Collaborator
Maria del Carmen Gogeascoechea Trejo	Adhera Health, Inc.

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Energy level	It is measured on a scale from 1 to 10. It can be classified as low from 1 to 4, normal from 5 to 7, and high when the user values it from 8 to 10.	From week 1 to week 12, every two days
Primary	Glycosylated Hemoglobin (Hb1Ac)	The parameter will be measured in % reported in the control cards of the Health Centers where a normal level is <5.7%, prediabetes is between 5.7% to 6.4% and diabetes is above 6.5%. In patients with DM, 6 to 7% is a desired level, 7.1 to 8.5% is a moderate risk, 8.5 to 10% is a high risk, and 10% or more is a very high risk for the appearance of complications (WHO, 2021). This parameter will be retrieved from the site's health record of the study participants.	Baseline
Primary	Glycosylated hemoglobin (Hb1Ac)	The parameter will be measured in % reported in the control cards of the Health Centers where a normal level is <5.7%, prediabetes is between 5.7% to 6.4% and diabetes is above 6.5%. In patients with DM, 6 to 7% is a desired level, 7.1 to 8.5% is a moderate risk, 8.5 to 10% is a high risk, and 10% or more is a very high risk for the appearance of complications (WHO, 2021). This parameter will be retrieved from the site's health record of the study participants.	Month 3
Primary	Triglycerides	Triglycerides will be measured as an indicator of fat metabolism based on the fatty acid count (GPC, 2018). Its values are classified as normal <150 mg/dL; high limit of 150 to 199 mg/dL; high from 200 to 499 m/dL and very high 500 mg/dL and more. This parameter will be retrieved from the site's health record of the study participants.	Baseline
Primary	Triglycerides	Triglycerides will be measured as an indicator of fat metabolism based on the fatty acid count (GPC, 2018). Its values are classified as normal <150 mg/dL; high limit of 150 to 199 mg/dL; high from 200 to 499 m/dL and very high 500 mg/dL and more. This parameter will be retrieved from the site's health record of the study participants.	Month 3
Primary	Total Cholesterol	Total cholesterol, which includes lipoproteins of different density in the body, will be assessed (GPC, 2018). Its values are classified as normal when they are <200 mg/dL; intermediate high when they are between 200 and 239 mg/dL and high when they are above 240 mg/dL. This parameter will be retrieved from the site's health record of the study participants.	Baseline
Primary	Total Cholesterol	Total cholesterol, which includes lipoproteins of different density in the body, will be assessed (GPC, 2018). Its values are classified as normal when they are <200 mg/dL; intermediate high when they are between 200 and 239 mg/dL and high when they are above 240 mg/dL. This parameter will be retrieved from the site's health record of the study participants.	Month 3
Primary	Body Mass Index	It will be measured on the scale proposed by the WHO with the formula weight (kg) / height2 (mts) with the following categories: underweight <18.5; normal weight of 18.5-24.9; overweight: 24.9-29.9 and obesity >30. This parameter will be retrieved from the site's health record of the study participants.	Baseline
Primary	Body Mass Index	It will be measured on the scale proposed by the WHO with the formula weight (kg) / height2 (mts) with the following categories: underweight <18.5; normal weight of 18.5-24.9; overweight: 24.9-29.9 and obesity >30. This parameter will be retrieved from the site's health record of the study participants.	Month 3
Primary	Blood Pressure	It is classified as optimal <120/80 mmHg; normal 120-129/80-84 mmHg; high normal 130-139 mmHg/85-89 mmHg; grade 1 hypertension of 140-159/90-99 mmHg; grade 2 hypertension of 160-179/100-109 mmHg and grade 3 hypertension >180/>110 mmHg (WHO, 2021). This parameter will be retrieved from the site's health record of the study participants.	Baseline
Primary	Blood Pressure	It is classified as optimal <120/80 mmHg; normal 120-129/80-84 mmHg; high normal 130-139 mmHg/85-89 mmHg; grade 1 hypertension of 140-159/90-99 mmHg; grade 2 hypertension of 160-179/100-109 mmHg and grade 3 hypertension >180/>110 mmHg (WHO, 2021). This parameter will be retrieved from the site's health record of the study participants.	Month 3
Primary	Abdominal Perimeter	According to the CPG (2018) in men, an abdominal circumference <95 cm is considered normal, from 95 to 102 cm as a high risk for complications and >102 cm is considered a very high level of risk, while in women <82 cm is considered normal, 82 to 88 cm represents a high risk and <88 cm is a very high risk. This parameter will be retrieved from the site's health record of the study participants.	Baseline
Primary	Abdominal Perimeter	According to the CPG (2018), in men an abdominal circumference <95 cm is considered normal, from 95 to 102 cm as a high risk for complications and >102 cm is considered a very high level of risk, while in women <82 cm is considered normal, 82 to 88 cm represents a high risk and <88 cm is a very high risk. This parameter will be retrieved from the site's health record of the study participants.	Month 3
Primary	Use of coping strategies	It is based on the instrument "Coping Strategies Inventory (CSI)" prepared by Tobin et al., (1989) adapted by Cano et al., (2007) with a global evaluation of 0 to 160 points where the higher the score, the greater the use of coping strategies.	Baseline
Primary	Use of coping strategies	It is based on the instrument "Coping Strategies Inventory (CSI)" prepared by Tobin et al., (1989) adapted by Cano et al., (2007) with a global evaluation of 0 to 160 points where the higher the score, the greater the use of coping strategies.	Month 3
Secondary	Use of health services	The instrument to assess the use of health services during the last 3 months is entitled "Questionnaire on the use of health services attributable to diabetes mellitus" from Betz Brown et al., (2014) and does not have a representative scale, it only provides the number of times you have attended emergency services in the last 90 days. Ideally, a patient with DM under control should not go to the emergency or hospitalization services.	Baseline
Secondary	Use of health services	The instrument to assess the use of health services during the last 3 months is entitled "Questionnaire on the use of health services attributable to diabetes mellitus" from Betz Brown et al., (2014) and does not have a representative scale, it only provides the number of times you have attended emergency services in the last 90 days. Ideally in a patient with DM under control should not go to the emergency or hospitalization services.	Month 3
Secondary	Usability	It explores the degree to which a user evaluates the characteristics of the intervention, such as ease of use, simplicity, efficiency, information and user interface. It is supported by the Computer System Usability Questionnaire (CSUQ) from Hedlefs et al., (2016) and is classified as <28 points is deficient; 29-56 points is acceptable; 57-84 points is good and 85-112 points is favorable.	Month 3