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CompletedNCT06034054Updated Sep 14, 2023

Acute Coronary Syndrome and Nurse Counselling

An interventional study of nursing counceling in Acute Myocardial Infarction and Coronary Artery Disease, sponsored by Iskenderun State Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Iskenderun State Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jul 2020, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Keywords

  • Acute Coronary Syndrome
  • Counseling
  • Nursing
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 66 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

This is the only study on the registry with Iskenderun State Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Nursing counseling

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

    Other: nursing counceling

  • No intervention
    Control

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

Interventions

  • Othernursing 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.

06

What researchers measure

Primary outcomes

  1. 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.)

    Time frame: 6 mounth

  2. Functional capacity

    Functional Capacity Evaluation Form will be applied.

    Time frame: 6 mounth

  3. 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.

    Time frame: 6 mount

07

Study locations

1 site
  • İskenderun State Hospital
    Hatay, 31200, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Feb 2021, 7 months.

Of 856 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 7 months is below that.

Counting every sponsor, half of 1,033 studies reached it within 29 months; a quarter within 14 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2023
First posted
Sep 13, 2023
StartActual
Jul 1, 2020
Primary completionActual
Feb 1, 2021
CompletionActual
Jul 1, 2021
Last update
Sep 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06034054
Lead sponsor
Iskenderun State Hospital
Responsible party
Deniz Gülistan ER (Angiography nurse, Iskenderun State Hospital) — Principal investigator
First posted
Sep 13, 2023
Start date
Jul 1, 2020
Primary completion
Feb 1, 2021
Completion
Jul 1, 2021
Last update
Sep 14, 2023

Study contacts

sevgin samancıoğlu bağlama, assoc.prof
study director · Muğla Sıtkı Koçman University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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