Effect of Digital Technologies on Risk Factor Modification

NCT03871907 | Completed

• 1 other identifier: DigTech
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Low-density lipoprotein cholesterol level at 6 months

  The primary end point was low-density lipoprotein cholesterol level at 6 months

  6 months

Secondary Outcomes (2)

• Systolic blood pressure

  6 months

• Body mass index (BMI)

  6 months

Study Arms (2)

Digital technology

ACTIVE COMPARATOR

standard cardiac rehabilitation program + 4 personalized short messages about risk factors modification 4 times per week

Behavioral: Digital technology

Control

NO INTERVENTION

standard cardiac rehabilitation program

Interventions

Digital technology BEHAVIORAL

Lifestyle-Focused Text Messaging

Digital technology

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary artery disease at the age of 18 to 75 years who are planning PCI for hemodynamically significant coronary artery stenosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Tyumen, 625026, Russia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Digital Technology

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Technology; Technology, Industry, and Agriculture

Study Officials

• Sergey V Popov

  Tomsk National Research Medical Center of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators who will perform follow-up will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 12, 2019
• Study Start: March 11, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 1, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)