Web Based Cardiac Rehabilitation Support in Coronary Artery Patients

NCT05489913 | Completed

• 1 other identifier: 24237859-534
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study was carried out as a randomized controlled experimental study to evaluate the effect of web-based cardiac rehabilitation support on the healthy lifestyle behaviors, medication adherence and quality of life in coronary heart patients.

Conditions

Cardiac Rehabilitation; Healthy Lifestyle; Medication Adherence; Quality of Life; Coronary Artery Disease

Outcome Measures

Primary Outcomes (9)

• Comparison of the total and sub-dimension total scores of the healthy lifestyle behaviors scale of the patients in the experimental and control groups

  Healthy Lifestyle Behaviors Scale II: The scale has 52 items and six factors.The lowest score obtained from the scale is 52, and the highest score is 208.Healthy lifestyle behaviors score is obtained from the overall score of the scale.High scores obtained from the scale indicate a high level of healthy lifestyle behaviors.

  twelve weeks

• Comparison of experimental and control group patients' compliance with medication adherence

  Medication Adherence Questions: There are three questions in order to evaluate the patients' compliance with drug therapy. These; It consists of questions such as "Do you have problems remembering to take your medicine regularly, do you stop taking your medicine without your doctor's advice when your complaints subside/end, if you don't feel well when you take your medicine (side effects etc.) do you stop taking your medicine?"

  twelve weeks

• Comparison of general quality of life scale index and general quality of life scale vas scores of experimental and control group patients

  EQ-5D General Quality of Life Scale: It was developed by the Western European Quality of Life Research Society. It consists of five dimensions. In these five dimensions; mobility and walking or walking, doing daily activities with normal daily activities, feeling of pain/discomfort and anxiety/depression and feeling anxious, etc. are evaluated. For the answers given to each dimension, there is no problem, there is some problem, and major problem options are included. A score between -0.59 and 1 is calculated from the five dimensions of the scale. A value of 0 is death, a value of 1 is perfect health, negative values are unconscious and bedridden, etc. points to the results. The scale also includes an easily understandable version of the rated Visual Analog Scale (VAS). Here, participants rate their overall health status from 0 to 100. A score of 100 represents the best health imaginable, while 0 represents the worst.

  twelve weeks

• Comparison of international physical activity questionnaire total scores and physical activity levels of experimental and control group patients

  International Physical Activity Questionnaire-Short Form: In the scale, walking for at least 10 minutes in the last 7 days, moderate-intensity and intense activities, and sedentary time spent in an average day are asked and metabolic equivalent (MET) scores are calculated. Total time (minutes) and frequency (days) are required to calculate the score. Results are evaluated in three categories: low level, intermediate level and high level. The low level is evaluated as \<600 MET, the intermediate level 600-3000 MET, and the high level \>3000 MET. The acceptable value in terms of health is expressed as intermediate level, ie 600-3000 MET.

  twelve weeks

• Comparison of body mass index values of experimental and control group patients

  The formula used to calculate the body mass index is as follows: height (cm)/weight (kg)\*weight (kg). After calculating the body mass index of each patient according to this formula, the data were compared.

  twelve weeks

• Comparison of LDL values of experimental and control group patients

  twelve weeks

• Comparison of smoking status of experimental and control group patients

  In the patient information form, patients were asked whether they smoked or not.

  twelve weeks

• Post-test Computer System Usability Questionaire Short Version total and sub-dimension scores of the experimental group patients

  Availability of a computer system; system usefulness (items 1-6), information quality (items 7-9), and interface dimensions (items 10-12) with 13 items. Each item is scored as 1 (strongly agree) and 7 (strongly disagree). The scale was set up in reverse, and low scores indicate good usability of the system.

  twelve weeks

• Comparison of triglyceride values of experimental and control group patients

  twelve weeks

Study Arms (2)

Web based Cardiac Rehabilitation program and follow-up telephone

EXPERIMENTAL

The website was created under the name of "Cardiac Rehabilitation Support Program". The language of the website is Turkish. Designed for computer, tablet and mobile phone use. Patients must be registered to access the website. After creating a six-digit password during registration, they log in to the website with their e-mail address and this password. The password is determined specifically for the patient. There is a welcome text on the home page of the website. The main headings in the menu section; trainings, disease management questions, questionnaires, ask questions to the researcher.

Other: cardiac rehabilitation support program

Standard care

NO INTERVENTION

patients received their training before discharge from the hospital and no intervention was made for 12 weeks.

Interventions

cardiac rehabilitation support program OTHER

First of all, a preliminary interview was made with the patients in the experimental group, and their information needs were evaluated individually. Which trainings he should receive and his priorities were determined with the patient. After the training requirements were determined, the general introduction of the website was made and they were allowed to register. Experimental group patients received both training on the website and counseling over the phone for 12 weeks after they started working. A total of 3 phone calls were made with the patients in the first week, 4th and 8th weeks. The interviews lasted an average of 20 minutes. In each phone call, patients were informed and reminded. When patients needed, an average of 2-3 more phone calls were made and information was provided on the subjects they needed.

Web based Cardiac Rehabilitation program and follow-up telephone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of Coronary artery disease, adult patients, those for whom no surgical operation was planned, those who were clinically stable, those who were literate, those who could communicate verbally, use the Internet, those who had a computer, tablet or smartphone, and those who agreed to participate in the study.

You may not qualify if:

• Those who have a disease that is not suitable for the CR program, those who did not agree to participate in the study, those who did not log in after registering on the website, did not read the trainings and could not communicate with the patient during the study

Sponsors & Collaborators

• Semiha ALKAN KAYHAN: lead

Study Sites (1)

Health Science University Ahi Evren thoracic and cardiovascular surgery training and research hospital

Trabzon, 61100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medication Adherence; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Semiha ALKAN KAYHAN

  ahi Evren thoracic and cardiovascular surgery training and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: March 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 30, 2021
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)