TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease

Study Overview
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Brief Summary
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Digital cardiology is gaining power in the field of preventive cardiology recently, and several trials have already shown good results of dietary therapy with digital cardiology. However, there has been no reports that showed effect of dietary counseling through digital cardiology for secondary prevention of coronary artery disease. TeleDiet study investigates the impact of dietary therapy with a smartphone application on the content of meals and metabolic parameters for patients with coronary artery disease.

Official Title
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TeleDiet Study: A Randomized Controlled Study Investigating the Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Owning a smartphone and able to use it Written informed consent obtained Starting cardiac rehabilitation Coronary artery disease Exclusion Criteria: Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet) Age <18 years old Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Device: Smartphone application<br>* Smartphone application named Signal, which connects patients and health providers<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MedDiet score (the Mediterranean diet score) | This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG]) |  | Up to 3 months | 
| Blood glycated hemoglobin (HbA1c) test |  | Up to 3 months | 
| Blood creatinine (Cr) test |  | Up to 3 months | 
| Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max]) |  | Up to 3 months | 
| Parameters in the ergospirometer test (anaerobic threshold [AT]) |  | Up to 3 months | 
| Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE]) | This scale has the extreme values of 10 (minimum) and 40 (maximum). Higher scores mean a better outcome. | Up to 3 months | 
| Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB]) | This scale has the extreme values of 30 (minimum) and 150 (maximum). Higher scores mean a worse outcome. | Up to 3 months | 
| Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL]) | This scale has the extreme values of 0 (minimum) and 42 (maximum). Higher scores mean a better outcome. | Up to 3 months | 
| Body weight (BW) |  | Up to 3 months | 
| Body mass index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Secondary Prevention, Diet Therapy