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

• Sponsor: Jessa Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05071495
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.3
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Smartphone application	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Mar 17, 2021
• Anticipated Primary Completion Date: Jul 25, 2022
• Anticipated Study Completion Date: Jul 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group	Device: Smartphone application; Smartphone application named "Signal", which connects patients and health providers
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

1. MedDiet score (the Mediterranean diet score) [Up to 3 months]

   This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.

Secondary Outcome Measures

1. Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG]) [Up to 3 months]

2. Blood glycated hemoglobin (HbA1c) test [Up to 3 months]

3. Blood creatinine (Cr) test [Up to 3 months]

4. Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max]) [Up to 3 months]

5. Parameters in the ergospirometer test (anaerobic threshold [AT]) [Up to 3 months]

6. Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE]) [Up to 3 months]

   This scale has the extreme values of 10 (minimum) and 40 (maximum). Higher scores mean a better outcome.

7. Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB]) [Up to 3 months]

   This scale has the extreme values of 30 (minimum) and 150 (maximum). Higher scores mean a worse outcome.

8. Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL]) [Up to 3 months]

   This scale has the extreme values of 0 (minimum) and 42 (maximum). Higher scores mean a better outcome.

9. Body weight (BW) [Up to 3 months]

10. Body mass index (BMI) [Up to 3 months]

    Weight and height will be combined to report BMI in kg/m^2.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Hospital	Hasselt	Limburg	Belgium	3500

Sponsors and Collaborators

• Jessa Hospital

Investigators

• Principal Investigator: Paul Dendale, Jessa Ziekenhuis vzw

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessa Hospital
• ClinicalTrials.gov Identifier: NCT05071495
• Other Study ID Numbers: 2020/171
• First Posted: Oct 8, 2021
• Last Update Posted: Apr 26, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jessa Hospital: Coronary Artery Disease; Secondary Prevention; Diet Therapy
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Apr 26, 2022