NCT06951958

Brief Summary

This research is conducted to determine whether the nurse-led Health Action Process Approach Model-based Cardiac Rehabilitation Program is effective in patients with myocardial infarction. The population of the study will consist of coronary angiography patients with myocardial infarction in the cardiology service of a state hospital. In this study, which is planned as a randomized controlled experimental model, 35 intervention and 35 control groups will be studied. As data collection tools; patient identification form, Laboratory Investigations Monitoring Form, Perceived Stress Scale, Health Action Process Approach Based Participant Assessment Form, Health Action Process Approach Based Myocardial Infarction Risk Factors Participant Assessment Form Functional Capacity Assessment Form, Myocardial Infarction Dimensional Assessment Scale and Turkish Modified Morisky Scale will be used. Health Action Process Approach Modeled Cardiac Rehabilitation Program will be applied to the intervention group and no intervention will be applied to the control group. Data will be collected with data collection tools at 6, 12, 24 weeks. SPSS 25.0 (Stastical Package for Social Science) package program will be used for statistical analysis of the data. Descriptive statistics will be given as number, percentage, mean, standard deviation and median values. The normal distribution of the data of numerical variables will be evaluated by Shapiro Wilk test. Two group comparisons will be made with independent two sample t-test for normally distributed variables and with Mann-Whitney U test for variables that do not show normal distribution. Comparisons of the groups' pre-test, week 6, week 18 and week 24 scale scores will be made with two-way analysis of variance in repeated measures from general linear models.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 23, 2025

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in treatment compliance of people participating in the Health Action Process Approach Model-based Cardiac Rehabilitation Program

    It was developed by Morisky et al. in 1986. It is a 6-item scale used to measure medication compliance in patients.

    At the beginning of the study (week 0), week 6, week 12 and week 24

Secondary Outcomes (1)

  • Changes in the Quality of Life of People Participating in a Cardiac Rehabilitation Program Based on the Health Action Process Approach Model

    At the beginning of the study (week 0), week 6, week 12 and week 24

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral Interventions will be provided to the intervention group using the Cardiac Rehabilitation Program based on the Health Action Process Approach Model.

Behavioral: Cardiac Rehabilitation Program Based on Health Action Process Approach Model

Control group

NO INTERVENTION

Interventions

The intervention program will start in the hospital setting and continue at home. A work schedule will be created with each individual in intervention group 1 by determining the times when they are available separately. Individuals are planned to receive 60-minute home visits once a week. In the following weeks, care interventions such as home visits, training, counseling and monitoring will be organized according to the specific needs and requirements of each individual. In the face-to-face preparation phase, the patient's health needs will be identified, health status will be assessed, daily activities will be reviewed, incompatibility between activity levels and recommended exercise guidelines will be examined, and individualized exercise goals and a behavior-specific exercise program will be created for behavioral changes. In the intervention phase, the parts that the patient lacks will be determined and the trainings needed will be given.

Intervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be between 18-70 years old,
  • Becoming literate,
  • Living in the city center
  • Having had a heart attack within the last month,
  • Not having had a heart attack before,
  • Dyspnea less than 4-5 degrees according to the modified Borg Scale
  • No deformity or diagnosis related to the musculoskeletal system that may prevent physical activity, no orthopedic limitation
  • Stable New York Heart Association (NHYA) functional class I or II coronary artery disease with myocardial infarction

You may not qualify if:

  • Those with communication disabilities such as speech, vision, hearing
  • Dyspnea score of more than 4-5 degrees according to the modified Borg Scale
  • Those who stayed in intensive care for a long time after MI
  • Complications related to treatment and interventions after MI
  • Those who underwent surgical treatment after MI,
  • Those with chronic diseases (chronic obstructive pulmonary disease, chronic renal failure, hypertension, diabetes, pulmonary emphysema, rheumatic valve disease, cancer diagnosis, etc.)
  • Those who indicated that they would not participate in intervention programs due to time constraints.
  • Failure of the six-minute walk test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 23, 2025

First Posted

April 30, 2025

Study Start

May 20, 2025

Primary Completion

November 20, 2025

Study Completion

June 10, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share