Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071495
Other study ID # 2020/171
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A