NCT06034054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

August 26, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

Acute Coronary SyndromeCounselingNursing

Outcome Measures

Primary Outcomes (3)

  • 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

  • Functional capacity

    Functional Capacity Evaluation Form will be applied.

    6 mounth

  • 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

Study Arms (2)

Nursing counseling

EXPERIMENTAL

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

Other: nursing counceling

Control

NO INTERVENTION

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

Interventions

* 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.

Nursing counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İskenderun State Hospital

Hatay, 31200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • sevgin samancıoğlu bağlama, assoc.prof

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Angiography nurse

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 13, 2023

Study Start

July 1, 2020

Primary Completion

February 1, 2021

Study Completion

July 1, 2021

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations