Disease Management for Coronary Artery Patients

NCT ID: NCT04556006

Last Updated: 2024-08-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Empowerment Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded, randomised-control study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Single blinded

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type ACTIVE_COMPARATOR

Patient education

Intervention Type 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.

Interventions

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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, 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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kilis 7 Aralik University

OTHER

Sponsor Role lead

Responsible Party

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Uğur Doğan

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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uğur doğan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Kilis 7 Aralık University

Kilis, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23166211 (View on PubMed)

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.

Reference Type RESULT
PMID: 21285019 (View on PubMed)

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.

Reference Type RESULT
PMID: 23507208 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34231274 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Kilis7AralikU

Identifier Type: -

Identifier Source: org_study_id

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