- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034054
Acute Coronary Syndrome and Nurse Counselling
September 12, 2023 updated by: Deniz Gülistan ER, Iskenderun State Hospital
The Effect of Nurse Counselling on Quality of Life, Functional Capacity and Knowledge, Attitudes and Beliefs in Patients With Acute Coronary Syndrome
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
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
-
-
-
Hatay, Turkey, 31200
- İskenderun State Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nursing counseling
The individuals included in nursing counseling group were given counseling by the research nurse for 6 months.
|
|
No Intervention: Control
Individuals included in control group were followed up routinely in the outpatient clinic for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional capacity
Time Frame: 6 mounth
|
Functional Capacity Evaluation Form will be applied.
|
6 mounth
|
Life quality
Time Frame: 6 mounth
|
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.)
|
6 mounth
|
Acute Coronary Syndromes
Time Frame: 6 mount
|
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.
|
6 mount
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: sevgin samancıoğlu bağlama, assoc.prof, Muğla Sıtkı Koçman University
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)
July 1, 2020
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
August 26, 2023
First Submitted That Met QC Criteria
September 5, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGulistan-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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