NCT06948123

Brief Summary

The effect of nursing approach based on Meleis's transition theory on cardiac quality of life and adaptation to disease in patients with acute myocardial infarction. This research was planned with the idea that the approach developed based on Meleis's Transition Theory could facilitate the illness-health transition process in patients, increase their healthy behavioral gains, increase the quality of care, reduce rehospitalizations, reduce the mortality rate due to MI, and contribute to the nursing literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

March 17, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

acute coronary syndrometransition theoryNursing Caries

Outcome Measures

Primary Outcomes (2)

  • Psychosocial Adjustment-Self-Report Measure (PAIS-SR ),

    Psychosocial Adjustment-Self-Report Measure: PAIS-SR: This scale assesses psychological adjustment to illness. Cronbach's alpha coefficient for the overall scale has been reported to be 0.92. The scale consists of 46 items and seven subscales. A total score of less than 35 indicates "good psychosocial adjustment," a score between 35 and 51 indicates "moderate psychosocial adjustment," and a score greater than 51 indicates "poor psychosocial adjustment."

    3 months for each patient.

  • Health-related Quality of Life scale (HEART-QOL)

    HEART-QOL: A tool developed to measure quality of life specific to heart disease. The questionnaire is a scale consisting of 27 items and 7-point Likert type responses, and has 3 sub-dimensions: emotional, physical and social. Scores are calculated by taking the average of the items for each dimension. Scores range from 1 to 7, with a low score indicating poor quality of life and a high score indicating better quality of life.

    3 months for each patient.

Study Arms (2)

Theory-based nursing intervention.

EXPERIMENTAL

This is the group that was trained with educational material prepared by the researcher based on Meleis's Transition Theory.

Other: Educational intervention

Control

OTHER

The control group was visited at home 15 days after discharge and the scales were applied. The final scales were applied to the patient who came to the hospital for 3 months. The patient was told that the study was over and given educational materials.

Other: control group

Interventions

The experimental group was trained with educational material prepared by the researcher using a computer at home for 15 days after hospital discharge.

Theory-based nursing intervention.

The control group was visited at home 15 days after discharge and the scales were applied. The final scales were applied to the patient who came to the hospital for 3 months. The patient was told that the study was over and given educational materials.

Control

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Among the patients who were hospitalized in the Cardiology Clinic of Aydın State Hospital and underwent emergency coronary angiography;
  • Those who were 18 years of age and older, diagnosed with MI,
  • Underwent coronary angiography for the first time,
  • Conscious,
  • No verbal communication barrier,
  • Able to read and write,
  • Had their polyclinic check-ups at the relevant hospital,
  • Agreed to participate in the study,
  • Had a telephone to communicate,
  • Living in Aydın city center and districts were included in the study.

You may not qualify if:

  • Patients with COPD,
  • Chronic renal failure,
  • Cancer, arrhythmia,
  • Advanced aortic stenosis and pulmonary hypertension,
  • Systemic or pulmonary embolism,
  • Chronic cognitive and psychiatric diseases,
  • Patients scheduled for organ transplantation,
  • Ptage 3 and 4 heart failure (according to New York Heart Association standards),
  • Patients with a hospital stay longer than 10 days were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin State Hospital

Aydin, AYDIN/Türkiye, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Early Intervention, EducationalControl Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • RAHŞAN ÇEVİK AKYIL, PROFESSOR

    Aydin Adnan Menderes University Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research was conducted with two groups as experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
internal medicine nursing PhD

Study Record Dates

First Submitted

March 17, 2025

First Posted

April 29, 2025

Study Start

December 1, 2023

Primary Completion

June 15, 2024

Study Completion

December 15, 2024

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

I do not want to disclose the work as I will publish it myself at certain times.

Locations