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

Официальное название

The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors in the Omani Population; Prospective Randomized Clinical Trial

Обзор

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 .

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Reduced blood cholesterol and triglycerides levels [Срок оценки: 18 months]
• Reduced blood glucose levels [Срок оценки: 18 months]
• Normalized blood pressure [Срок оценки: 18 months]
• Reduced BMI and visceral obesity [Срок оценки: 18 months]

Вторичные конечные точки (2)

• Increased physical activity and increased intake of healthy diet [Срок оценки: 18 months]
• Reduced alcohol consumption and tobacco smoking [Срок оценки: 18]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05798442 · Opulse app

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗