Disease Management for Coronary Artery Patients

NCT04556006 | Completed Results

• 1 other identifier: Kilis7AralikU
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Empowerment; Coronary Artery Disease

Keywords

Training; Disease Management; Nursing; Coronary Artery Disease; Compliance

Outcome Measures

Primary Outcomes (1)

• Compliance Questionnaire Scores of the Participants

  Compliance Questionnaire 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 Compliance Questionnaire score for each participant is determined. The score range that can be obtained for each subscale is 0-4. The Compliance Questionnaire total scores is between 0-44. High scores mean a better as it an increase in the compliance level to the disease.

  Initially-12 weeks

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

ACTIVE COMPARATOR

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

Interventions

Patient education OTHER

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, Framingham Risk 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.

Intervention

Eligibility Criteria

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

You may qualify if:

• aged 18 and over,
• diagnosed with coronary artery disease 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.

You may not qualify if:

• aged 18 under,
• diagnosed without coronary artery disease 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.

Sponsors & Collaborators

• Kilis 7 Aralik University: lead

Study Sites (1)

Kilis 7 Aralık University

Kilis, 79100, Turkey (Türkiye)

Location

Related Publications (4)

• Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV, Anderson JL; American College of Cardiology Foundation/American Heart Association Task Force. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012 Dec 18;126(25):e354-471. doi: 10.1161/CIR.0b013e318277d6a0. Epub 2012 Nov 19. No abstract available.

  PMID: 23166211 RESULT

• Kurcer MA, Ozbay A. [Effects of patient education and counseling about life style on quality of life in patients with coronary artery disease]. Anadolu Kardiyol Derg. 2011 Mar;11(2):107-13. doi: 10.5152/akd.2011.028. Epub 2011 Feb 2. Turkish.

  PMID: 21285019 RESULT

• Bitton A, Choudhry NK, Matlin OS, Swanton K, Shrank WH. The impact of medication adherence on coronary artery disease costs and outcomes: a systematic review. Am J Med. 2013 Apr;126(4):357.e7-357.e27. doi: 10.1016/j.amjmed.2012.09.004.

  PMID: 23507208 RESULT

• Dogan U, Ovayolu N. The effect of training on treatment adherence in coronary artery patients: A single-blind randomised controlled trial. J Clin Nurs. 2022 Mar;31(5-6):744-754. doi: 10.1111/jocn.15933. Epub 2021 Jul 6.

  PMID: 34231274 DERIVED

MeSH Terms

Conditions

Patient Participation; Coronary Artery Disease; Patient Compliance

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Uğur Doğan
• Organization: Kilis 7 Aralık University

63ugurdogan@gmail.com

+903488139301

Study Officials

• uğur doğan, Ph.D

  Lecturer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Single blinded, randomised-control study

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 21, 2020
• Study Start: March 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 months after the study is completed
• Access Criteria: All data

Locations

TU (1)