Disease Management for Coronary Artery Patients

September 14, 2020 updated by: Uğur Doğan, Kilis 7 Aralik University

The Effect of Training Given to Coronary Artery Patients on Disease Management

This randomized controlled trial was conducted with 58 patients hospitalized in the cardiology clinic of a state hospital. Personal Information Form, Anthropometric measurements, Framingham risk score, and compliance questionnaire (CQ) were used to collect the data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kilis, Turkey, 79100
        • Kilis 7 Aralık University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18 and over,
  • diagnosed with CAD for at least 2 months,
  • no hearing and vision problem,
  • no perception and expression deficiency,
  • not diagnosed with any psychiatric disease,
  • living in Kilis province,
  • voluntary to participate in the study.

Exclusion Criteria:

  • aged 18 under,
  • diagnosed without CAD for at least 2 months,
  • hearing and vision problem,
  • perception and expression deficiency,
  • diagnosed with any psychiatric disease,
  • no living in Kilis province,
  • no voluntary to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The patients in the control group received only the standard care provided by the clinicians. After the collection of post-test data, the content of the training was also explained to these patients and the study was completed by giving them the training guide.
Active Comparator: İntervention
The training program was applied by the researcher who also work as an academic nurse. The contact information of the patients was obtained and the contact information of the researcher was also given to the patients. In order to consolidate the information given, the training guide was given to the patients in the intervention group. After the training, the patients in the intervention group were contacted again in the 2nd week by using face-to-face interview and in the 4th-8th and 12th weeks by phone calls. During these interviews, the questions of the patients, if any, were answered and the problems they faced regarding the disease management were tried to be solved. In the last interview, an appointment day was determined to meet face-to-face at home, workplaces or hospital according to the preferences of the patients.
Other: Patient education

The data collection process of the study was carried out in two stages using data collection tools.

First stage: Personal Information Form and Compliance Questionnaire were applied to all patients in both groups. After anthropometric measurements, FR score was determined. The data collection forms were filled with the patients using face-to-face interview technique. The data collection process lasted for approximately 10-15 minutes. After the data collection, the patients in the intervention group were trained. No training was given to the patients in the control group but they received a "Coronary Artery Disease Management Guide".

Second stage: 12 weeks after the first interview, the patients were interviewed again face-to-face interview technique and the forms and measurements applied initially were repeated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CQ scores of the participants
Time Frame: Initially-12 weeks

Compliance Questionnaire (CQ) is a form allowing to investigate 11 different areas such as the use of medication causing maladaptation in disease management in individuals with chronic illnesses, diet, weight loss, limiting physical activity, exercise, coping with stress, alcohol use, smoking, sexual activity problems, caffeine intake and working/job life.

In the form allowing Likert-type evaluation, the participant is expected to select one of the options 0 (never), 1 (very rarely), 2 (sometimes), 3 (most of the time) or 4 (always) while expressing his/her compliance level for each adaptation area. The scores corresponding to the given expression are summed and CQ score for each participant is determined. The maximum score is 44. High score signifies an increase in the compliance level to the disease.
Initially-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kilis 7 Aralik University

Investigators

  • Principal Investigator: uğur doğan, Ph.D, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kilis7AralikU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

IPD Sharing Time Frame

3 months after the study is completed

IPD Sharing Access Criteria

All data

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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