TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Smartphone application
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Secondary Prevention, Diet Therapy
Eligibility Criteria
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
Sites / Locations
- Jessa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
MedDiet score (the Mediterranean diet score)
This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.
Secondary Outcome Measures
Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])
Blood glycated hemoglobin (HbA1c) test
Blood creatinine (Cr) test
Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
Parameters in the ergospirometer test (anaerobic threshold [AT])
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.
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.
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.
Body weight (BW)
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05071495
Brief Title
TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Secondary Prevention, Diet Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Smartphone application
Intervention Description
Smartphone application named "Signal", which connects patients and health providers
Primary Outcome Measure Information:
Title
MedDiet score (the Mediterranean diet score)
Description
This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])
Time Frame
Up to 3 months
Title
Blood glycated hemoglobin (HbA1c) test
Time Frame
Up to 3 months
Title
Blood creatinine (Cr) test
Time Frame
Up to 3 months
Title
Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
Time Frame
Up to 3 months
Title
Parameters in the ergospirometer test (anaerobic threshold [AT])
Time Frame
Up to 3 months
Title
Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])
Description
This scale has the extreme values of 10 (minimum) and 40 (maximum). Higher scores mean a better outcome.
Time Frame
Up to 3 months
Title
Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])
Description
This scale has the extreme values of 30 (minimum) and 150 (maximum). Higher scores mean a worse outcome.
Time Frame
Up to 3 months
Title
Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])
Description
This scale has the extreme values of 0 (minimum) and 42 (maximum). Higher scores mean a better outcome.
Time Frame
Up to 3 months
Title
Body weight (BW)
Time Frame
Up to 3 months
Title
Body mass index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Dendale
Organizational Affiliation
Jessa Ziekenhuis vzw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
We'll reach out to this number within 24 hrs