Effect of Digital Technologies on Risk Factor Modification (NCT03871907) | Clinical Trial Compass
CompletedNot Applicable
Effect of Digital Technologies on Risk Factor Modification
Russia700 participantsStarted 2019-03-11
Plain-language summary
DigTech investigates the effect of a text message-based intervention to encourage lifestyle change on objective measures of cardiovascular risk in individuals with coronary heart disease (CHD) after percutaneous coronary intervention (PCI).
DigTech will recruit 700 participants from 18-75 years old with CHD after PCI. Half of the participants will be randomised into a 24 week intervention trial, which includes sending 4 personalized short messages about risk factors modification 4 times per week and the other half will be controls.
Participants will complete 3 main study visits:
* Visit 1: Baseline visit conducted at the beginning of the study
* Visit 2: Randomization
* Visit 3: End of study (24 weeks). Each visit will repeat the same set of cardiovascular measures including information about previous treatment, blood pressure, ECG, echocardiography, stress tests, blood sampling, International Physical Activity Questionnaires (IPAQ) and other measures.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with coronary artery disease at the age of 18 to 75 years who are planning PCI for hemodynamically significant coronary artery stenosis.
Exclusion Criteria:
* Severe comorbidities (malignant tumors, severe lung diseases, marked cognitive impairment).
* Severe CHF (EF LV \<35% or functional class of heart failure III-IV NYHA).
* Severe valvular heart disease or Prosthetic heart valves.
* Severe diseases of the musculoskeletal system.
* The patient's reluctance to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Low-density lipoprotein cholesterol level at 6 months
Timeframe: 6 months
Trial details
NCT IDNCT03871907
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences