Coronary Artery DiseaseNCT05071495
TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
A study testing Smartphone application in people with Coronary Artery Disease, run by Jessa Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Mar 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Owning a smartphone and able to use it
- Written informed consent obtained
- Starting cardiac rehabilitation
- Coronary artery disease
Who cannot join
- Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
- Age <18 years old
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Smartphone application
- Keywords
- Coronary Artery Disease, Secondary Prevention, Diet Therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone applicationDevice
Smartphone application named "Signal", which connects patients and health providers
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: Smartphone application |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MedDiet score (the Mediterranean diet score)
This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.
Measured: Up to 3 months
Secondary outcomes (10)
Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])
Measured: Up to 3 months
Blood glycated hemoglobin (HbA1c) test
Measured: Up to 3 months
Blood creatinine (Cr) test
Measured: Up to 3 months
Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
Measured: Up to 3 months
Parameters in the ergospirometer test (anaerobic threshold [AT])
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Body weight (BW)
Measured: Up to 3 months
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start17 Mar 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Dendale, Principal investigator, Jessa Ziekenhuis vzw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071495
- Sponsor's protocol ID
- 2020/171
- Status last verified
- Apr 2022
- First submitted
- 13 Sep 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05071495
- Acronym / sponsor ID
- 2020/171
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Secondary Prevention, Diet Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Smartphone application |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Owning a smartphone and able to use it
- Written informed consent obtained
- Starting cardiac rehabilitation
- Coronary artery disease
Key exclusion criteria (3 listed)
- Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
- Age <18 years old
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone applicationSmartphone application named "Signal", which connects patients and health providers | Device | Intervention group |
Primary outcome
MedDiet score (the Mediterranean diet score)
Time frame: Up to 3 months
This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.
10 secondary outcomes
Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])
Time frame: Up to 3 months
Blood glycated hemoglobin (HbA1c) test
Time frame: Up to 3 months
Blood creatinine (Cr) test
Time frame: Up to 3 months
Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
Time frame: Up to 3 months
Parameters in the ergospirometer test (anaerobic threshold [AT])
Time frame: Up to 3 months
Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])
Time frame: Up to 3 months
Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])
Time frame: Up to 3 months
Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])
Time frame: Up to 3 months
Body weight (BW)
Time frame: Up to 3 months
Body mass index (BMI)
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dendale principal investigator
Jessa Ziekenhuis vzw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application in people with Coronary Artery Disease, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MedDiet score (the Mediterranean diet score) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.