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Disease Management for Coronary Artery Patients

Primary Purpose

Patient Empowerment, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patient education
Sponsored by
Kilis 7 Aralik University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Empowerment focused on measuring Training, Disease Management, Nursing, Coronary Artery Disease, Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kilis 7 Aralık University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

İntervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

CQ scores of the participants
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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2020
Last Updated
September 14, 2020
Sponsor
Kilis 7 Aralik University
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1. Study Identification

Unique Protocol Identification Number
NCT04556006
Brief Title
Disease Management for Coronary Artery Patients
Official Title
The Effect of Training Given to Coronary Artery Patients on Disease Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kilis 7 Aralik University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Empowerment, Coronary Artery Disease
Keywords
Training, Disease Management, Nursing, Coronary Artery Disease, Compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blinded, randomised-conrol study
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
İntervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patient education
Intervention Description
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.
Primary Outcome Measure Information:
Title
CQ scores of the participants
Description
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.
Time Frame
Initially-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
uğur doğan, Ph.D
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kilis 7 Aralık University
City
Kilis
ZIP/Postal Code
79100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
Citations:
PubMed Identifier
23166211
Citation
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. Erratum In: Circulation. 2014 Apr 22;129(16):e463.
Results Reference
result
PubMed Identifier
21285019
Citation
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.
Results Reference
result
PubMed Identifier
23507208
Citation
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.
Results Reference
result
PubMed Identifier
34231274
Citation
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.
Results Reference
derived

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Disease Management for Coronary Artery Patients

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