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Acute Coronary Syndrome and Nurse Counselling

Primary Purpose

Acute Myocardial Infarction, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nursing counceling
Sponsored by
Iskenderun State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Myocardial Infarction focused on measuring Acute Coronary Syndrome, Counseling, Nursing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years old, diagnosed with Acute Coronary Syndrome and treated with a stent, Treatment preventing communication is not a problem, literate, There is no obstacle to performing the 6-minute walk test. who did not accept to participate, were included in the study. Exclusion Criteria: <18 years of age, Mental or cognitive impairment, Diagnosed with SpO2 <80, Peripheral arterial disease, lower extremity amputation, impaired tumor or open wound of lower extremity, and deep vein thrombosis, 6 munites corridor Walk test Parts of individuals who are contraindicated in making are not included.

Sites / Locations

  • İskenderun State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nursing counseling

Control

Arm Description

The individuals included in nursing counseling group were given counseling by the research nurse for 6 months.

Individuals included in control group were followed up routinely in the outpatient clinic for 6 months.

Outcomes

Primary Outcome Measures

Life quality
Multidimensional index of life quality will be applied(This scale is the "multidimensional quality of life scale", the Turkish validity and reliability of which was established in 2012.)
Functional capacity
Functional Capacity Evaluation Form will be applied.
Acute Coronary Syndromes
Acute Coronary Syndrome Response Index will be applied.It was translated into Turkish and a reliability and validity study was conducted in 2016. A questionnaire consisting of 33 items was applied to evaluate the knowledge, attitudes and beliefs of individuals with acute coronary syndrome regarding the disease.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2023
Last Updated
September 12, 2023
Sponsor
Iskenderun State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06034054
Brief Title
Acute Coronary Syndrome and Nurse Counselling
Official Title
The Effect of Nurse Counselling on Quality of Life, Functional Capacity and Knowledge, Attitudes and Beliefs in Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iskenderun State Hospital

4. Oversight

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

5. Study Description

Brief Summary
The goal of this clinical trial is to examine in patients with acute coronary syndrome. The main questions it aims to answer are: Does nurse counseling affect quality of life? Does nurse counseling affect functional capacity? Does nurse counseling affect knowledge, attitudes and beliefs about syndromes? Participants will be trained using the training booklet, and nursing counseling will then be provided for six months. If there is a comparison group: Researchers will compare with the control group to see if the nurse counseling has had an effect.
Detailed Description
After obtaining verbal and written consent from the participants, they are required to answer the questions on the Diagnosis Form, Acute Coronary Syndrome Response Index, and Multiple Quality of Life Scale. Then, preliminary measurements will be made and a 6-minute corridor walking test will be applied. While the control group will be followed up routinely, the training booklet prepared for the intervention group will be explained orally. Participants will then be informed that they will be called monthly. They will be told that they can reach these monthly calls and consult the nurse when they need it. After this stage, interviews with patients will begin. The standard way of communication with the participants by the researchers is by telephone, and a total of 6 interviews will be provided, the first of which is in the 1st month after the application of the tests. In each call, all the information in the training booklet will be repeated, additional information will be given in line with the needs and demands of the person, their questions will be answered and the interview will be ended. Although it varies according to the individual interviewed, it is predicted that these telephone interviews will last for 30 minutes on average. Apart from these standard calls, individuals in need will be able to reach the researcher face-to-face during phone calls, text messages, instant messaging methods or hospital visits, and in this way, the counseling process will continue actively for 6 months. After six months, the final tests will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Coronary Artery Disease
Keywords
Acute Coronary Syndrome, Counseling, Nursing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nursing counseling
Arm Type
Experimental
Arm Description
The individuals included in nursing counseling group were given counseling by the research nurse for 6 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals included in control group were followed up routinely in the outpatient clinic for 6 months.
Intervention Type
Other
Intervention Name(s)
nursing counceling
Intervention Description
Providing an educational booklet containing information about pastry, verbally explaining the content of the prepared educational booklet. Answering the information and questions that the patient needs in addition, and receiving contact information in October. Monthly calls will be made to patients 6. providing information that the same tests will be performed again per month, if necessary, this monthly call counseling by reaching out without waiting indicating what they can receive.
Primary Outcome Measure Information:
Title
Life quality
Description
Multidimensional index of life quality will be applied(This scale is the "multidimensional quality of life scale", the Turkish validity and reliability of which was established in 2012.)
Time Frame
6 mounth
Title
Functional capacity
Description
Functional Capacity Evaluation Form will be applied.
Time Frame
6 mounth
Title
Acute Coronary Syndromes
Description
Acute Coronary Syndrome Response Index will be applied.It was translated into Turkish and a reliability and validity study was conducted in 2016. A questionnaire consisting of 33 items was applied to evaluate the knowledge, attitudes and beliefs of individuals with acute coronary syndrome regarding the disease.
Time Frame
6 mount

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old, diagnosed with Acute Coronary Syndrome and treated with a stent, Treatment preventing communication is not a problem, literate, There is no obstacle to performing the 6-minute walk test. who did not accept to participate, were included in the study. Exclusion Criteria: <18 years of age, Mental or cognitive impairment, Diagnosed with SpO2 <80, Peripheral arterial disease, lower extremity amputation, impaired tumor or open wound of lower extremity, and deep vein thrombosis, 6 munites corridor Walk test Parts of individuals who are contraindicated in making are not included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sevgin samancıoğlu bağlama, assoc.prof
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
Facility Information:
Facility Name
İskenderun State Hospital
City
Hatay
ZIP/Postal Code
31200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acute Coronary Syndrome and Nurse Counselling

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