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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071495
• Other study ID #: 2020/171
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2022
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Owning a smartphone and able to use it

2. Written informed consent obtained

3. Starting cardiac rehabilitation

4. Coronary artery disease

Exclusion Criteria:

1. Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)

2. Age <18 years old

3. Pregnancy

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Smartphone application
Smartphone application named "Signal", which connects patients and health providers

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])		Up to 3 months
Secondary	Blood glycated hemoglobin (HbA1c) test		Up to 3 months
Secondary	Blood creatinine (Cr) test		Up to 3 months
Secondary	Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])		Up to 3 months
Secondary	Parameters in the ergospirometer test (anaerobic threshold [AT])		Up to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Body weight (BW)		Up to 3 months
Secondary	Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Up to 3 months