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

March 23, 2023 updated by: Dr. Amani Alkhaifi, Sultan Qaboos University

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

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduced blood cholesterol and triglycerides levels
Time Frame: 18 months

Immunoassay based-method will be used to measure lipid profile in the blood samples collected from the study participants. Lipids will be measured in millimole/Liter This outcome will be achieved when the Participants lipid profile is reduced compared to the initial values (measured at the beginning of the study)

The assessment will be base don the ranges below:

Total Cholesterol (mmol/L): < 5.2 / TG (mmol/L): (0 - 2.3) / LDL-C (mmol/L): < 2.59 / HDL-C (mmol/L): > 1.68 (Female) >1.45 (Male)
18 months
Reduced blood glucose levels
Time Frame: 18 months

Glucometer devices for fasting blood glucose and for glycated hemoglobin will be used to asses the improvement in impaired glycemia.

Participants who achieve this outcome would have reduced blood glucose compared to the initial values (measured at the beginning of the study)

The following measures will be used to asses the glycemic state of the pateints

Fasting blood glucose: (Norma < 5.6 mmol/L), (Impaired glycemia/type 2 diabetes ≥ 5.6 mmol/L) Glycated hemoglobin (HbA1c): (Normal < 5.7 %), (> 6.5 Diabetes)
18 months
Normalized blood pressure
Time Frame: 18 months

systolic blood pressure and diastolic blood pressure of the participants will measured throughout the study using sphygmomanometer

The measures below will be used to assess the improvement in the blood pressure of the participants Hypertension: systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg Normal blood pressure: systolic: < 120 mm Hg/ diastolic < 80 mm Hg
18 months
Reduced BMI and visceral obesity
Time Frame: 18 months

Anthropometric measurements (height, weight, waist and hip circumferences) will be taken from the participants throughout the study.

Body Mass Index (BMI) will be measured using the formula BMI = weight(kg)/height(m2).

Desired BMI is in the range of 18.5 to 24.9, A BMI of 25.0 or more is overweight

Visceral obesity will be assed by measuring the waist-to-hip ratio Female: > 0.85 No visceral obesity, < 0.85 existing visceral obesity Male: > 1.0 No visceral obesity, < 1.0 existing visceral obesity
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Increased physical activity and increased intake of healthy diet
Time Frame: 18 months

The daily physical activity will will be measured by pedometer feature of the mobile application in the form of number of foot steps.

Intake of healthy diet will also be assessed using the mobile application by counting the number of vegetables/fruits servings per day.

The overall increase in the physical activity and intake of healthy diet will be assessed during the study visits (every 4 months) using a standardized validated questionnaires namely "Dubasi questionnaire on dietary intake and physical activity". This questionnaire is based on likert score (Dubasi, S.K., et al., Questionnaire to assess adherence to diet and exercise advices for weight management in lifestyle-related diseases. J Family Med Prim Care, 2019. 8(2): p. 689-694.)
18 months
Reduced alcohol consumption and tobacco smoking
Time Frame: 18
The reduction in alcohol consumption and tobacco smoking will be assessed using Standardized validated questionnaires The Fagerström test for Nicotine Dependence which asses the intensity of physical addiction to nicotine Alcohol Use Disorders Identification Test (AUDIT) questionnaire
18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sultan Qaboos University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Higher Education, Research and Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amani Alkhaifi, PhD, Sultan Qaboos University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2024

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Opulse app

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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