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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06034054
Other study ID # DGulistan-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date July 1, 2021

Study information

Verified date September 2023
Source Iskenderun State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
nursing counceling
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.

Locations

Country Name City State
Turkey Iskenderun State Hospital Hatay

Sponsors (1)

Lead Sponsor Collaborator
Iskenderun State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.) 6 mounth
Primary Functional capacity Functional Capacity Evaluation Form will be applied. 6 mounth
Primary 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. 6 mount
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