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

NCT05924516 | Unknown DMC

• 1 other identifier: U1111-1284-0047
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Digital Interventions, mHealth, fatigue, behavioral

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Use of health services

  Baseline

• Use of health services

  Month 3

• Usability

  Month 3

Other Outcomes (1)

• Energy level

  From week 1 to week 12, every two days

Study Arms (2)

Control Group

NO INTERVENTION

Control Group: Standard Treatment

Experimental Group

EXPERIMENTAL

Experimental Group: Standard Treatment + Adhera® Fatigue Digital Program

Behavioral: Adhera® Fatigue Digital Program

Interventions

Adhera® Fatigue Digital Program BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria del Carmen Gogeascoechea Trejo: lead
• Adhera Health, Inc.: collaborator

Study Sites (3)

Clínic "José A. Maraboto" Street Santiago Bonilla 85

Xalapa, Veracruz, 91020, Mexico

Location

Clinic "Revolución" Street Valentín Canalizó, 12

Xalapa, Veracruz, 91110, Mexico

Location

Clinic "Miguel Alemán" Avenue Miguel Alemán 107

Xalapa, Veracruz, 91140, Mexico

Location

Related Publications (4)

• 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.

  PMID: 30377185 BACKGROUND

• 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.

  PMID: 32338624 BACKGROUND

• 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.

  PMID: 25216268 BACKGROUND

• 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.

  PMID: 17323223 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Fatigue; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María del Carmen Gogeascoechea Trejo, PhD

  Universidad Veracruzana

  STUDY DIRECTOR

Central Study Contacts

Oscar Rodriguez Montes, MsC

CONTACT

+522281103876; oscrodriguez@uv.mx

Luis Fernandez-Luque, PhD

CONTACT

luis@adherahealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD on Sciences Health

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)