The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors

NCT ID: NCT05798442

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2027-12-30

Brief Summary

This study investigates the effectiveness of Mobile health application (mHealth apps) in the improvement of cardiovascular disease risk factors including metabolic and behavioral factors. The app will be tested on patients with any of the modifiable risk factors of CVD such as hypertension, obesity, hyperlipidemia, and impaired glycemic control/type 2 diabetes mellitus .

Detailed Description

The investigators aim in this study to reduce the risk of cardiovascular disease in patients with hypercholesterolemia, diabetes, obesity and hypertension. This will be achieved by motivating healthy lifestyle among the participants such as increasing physical activity and intake of healthy diet and reducing alcohol and tobacco consumption. The tool which will be used to motivate healthy lifestyle is a smartphone application which will be specifically designed to motivate behavioral change. Thus, the investigators hypothesis is that participants who have full access to the mobile application will show improved healthy lifestyle, reduced blood pressure, cholesterol and glucose and reduced BMI compared to the participants who don't have access to the mobile application.

Conditions

Hypercholesterolemia; Obesity; Diabetes Mellitus; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

mHealth app-based intervention group

The app-based intervention group will be given access to a mHealth app that will be specifically designed to motivate the users to increase their physical activity and healthy diet intake while reducing smoking and alcohol intake. The app provides the patients with standardized dietary and exercise guidelines and sends them frequent advice and reminders to follow the guidelines. Changes in the CVD risk factors of the participants will be assessed based on blood biochemical and anthropometric measurements collected every 4 months over a period of 20 months. The app will be designed to include interactive functions which allow the patients to insert their daily caloric intake and exercise, biometric data, track the improvement in their CVD risk factors and CVD risk score.

Group Type: EXPERIMENTAL

smartphone health application (Opulse)

Intervention Type: OTHER

The Opulse app will be designed as a multifunction app that targets the modification of the behavioral and metabolic risk factors and provides comprehensive interventions for healthy diet, physical activity and smoking cessation among smokers.

face-to-face consultation group

This group of patients will not have access to mHealth app and will receive the traditional face to face intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

smartphone health application (Opulse)

The Opulse app will be designed as a multifunction app that targets the modification of the behavioral and metabolic risk factors and provides comprehensive interventions for healthy diet, physical activity and smoking cessation among smokers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Presentation with at least one of the following metabolic abnormalities:
• Hypertensions (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg)
• Obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and BMI ≥ 25 kg/m2)
• Dyslipidemia (triglycerides ≥ 1.7 mmol/L or/and HDL-cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men) or/and LDL-Cholesterol > 5.18 mmol/L, serum total cholesterol ≥ 5.2 mmol/l)
• Impaired glycemia/type 2 diabetes (fasting plasma glucose ≥ 5.6 mmol/L)
• Arabic or English language speaking and able to read and write in one of these languages
• Possession of a smart mobile phone Willing to utilize a mobile application for CVD management.

Exclusion Criteria

• A history of stroke, myocardial infarction or any related cardiovascular complications Complicated diabetes mellitus e.g., Proliferative diabetic retinopathy, end-stage renal disease
• Unavailability of a smartphone or any reason that will not allow the participant to use the app properly. (such as; difficulty or inability to use mobile applications, unavailability of network services…etc.).
• Medical conditions that restrain the participant to be physically active.
• High chance of loss to follow up at the FAMCO clinic (due to upcoming travel, temporary employment and thus eligibility to be treated at the clinic, irregular visits due to distance from home…etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Higher Education, Research and Innovation

AMBIG

Sponsor Role: collaborator

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amani Alkhaifi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amani Alkhaifi, PhD

Role: PRINCIPAL_INVESTIGATOR

Sultan Qaboos University

Central Contacts

Amani Alkhaifi, PhD

Role: CONTACT

amani@squ.edu.om

+96899245544

Hana Alsumri, PhD

Role: CONTACT

alsumry@squ.edu.om

+96895085861

Other Identifiers

Opulse app

Identifier Type: -

Identifier Source: org_study_id