NCT06882044

Brief Summary

Background and Aim: Acute myocardial infarction is a clinical condition with high mortality and morbidity rates. Ensuring patient adherence to treatments and lifestyle recommendations after discharge is crucial for effective post-acute myocardial infarction management. This study aimed to determine the impact of a mobile application on treatment adherence, self-management, and quality of life in patients with acute myocardial infarction undergoing primary percutaneous coronary ıntervention. Material and Methods: This randomized controlled and experimental study was conducted between 2021 and 2024 at the cardiology clinic of a university hospital. It included patients who had their first time with ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention (n=31/30). The control group was provided standard discharge education with the "Educational Booklet for Patients Who Have Had a Heart Attack". The intervention group, in addition to these practices, mobile application support was provided. They were followed up for 6 months post-discharge. Data were collected at 1, 3 and 6 months. The patient information form including characteristics related to lifestyle changes, Medication Adherence Reporting Scale (MARS), and Myocardial Infarction Dimensional Assessment Scale (MIDAS) were used in data collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

February 6, 2025

Last Update Submit

March 14, 2025

Conditions

Keywords

Mobile health applicationacute myocardial infarctiontreatment adherenceself-care managementquality of life

Outcome Measures

Primary Outcomes (2)

  • Medication adherence

    Medication Adherence Report Scale: The total score obtained from the scale varies between 5 and 25. A high total score indicates adherence to medication treatment, while a low score indicates non-adherence to medication treatment.

    at 1, 3, and 6 months following their discharge

  • Self-management

    This title contains adherence of individuals to lifestyle change recommendations. The questions in this section are: Status of smoking, status of regular physical activity/exercise (\>150 min/week), status of consumption of fruit and vegetables per ≥5 days a week and status of consumption of \<500 g of red meat per week.

    at 1, 3, and 6 months following their discharge

Secondary Outcomes (1)

  • Quality of life of individuals with Myocardial Infarction

    at 1, 3, and 6 months following their discharge

Study Arms (2)

Control Group

NO INTERVENTION

Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack'

Intervention group

EXPERIMENTAL

Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack' and using Mobile Health Application (mHealth)

Device: mHealth

Interventions

mHealthDEVICE

The mobile application contains medication and personalised reminders, the screen where blood pressure and pulse are entered, the lifestyle change recommendations information, and the section that allows users to communicate with the researcher. Also, there is a control panel that allows the application to be controlled remotely, patient information to be viewed, data to be monitored, lifestyle information to be uploaded and viewed in the mHealth, personalised reminders to be sent to patients, and communication with patients.

Intervention group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention,
  • Above the age of 18,
  • Have a smart phone,
  • Have internet access,
  • Have orientation to place, time, and situation,
  • Have no problems with vision, hearing, or speech,
  • Have minimal literacy,
  • Patients who volunteer to participate in the study

You may not qualify if:

  • Patients who want to leave the study,
  • Patients who do not come to their doctor's check-ups regularly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Centre, 22030, Turkey (Türkiye)

Location

Related Publications (27)

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    PMID: 35441926BACKGROUND
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    PMID: 38648103BACKGROUND
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    PMID: 21652294BACKGROUND
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    PMID: 39052330BACKGROUND
  • Turan Kavradim S, Canli Ozer Z. The effect of education and telephone follow-up intervention based on the Roy Adaptation Model after myocardial infarction: randomised controlled trial. Scand J Caring Sci. 2020 Mar;34(1):247-260. doi: 10.1111/scs.12793. Epub 2019 Nov 26.

    PMID: 31769891BACKGROUND
  • Pietrzykowski L, Michalski P, Kosobucka A, Kasprzak M, Fabiszak T, Stolarek W, Siller-Matula JM, Kubica A. Medication adherence and its determinants in patients after myocardial infarction. Sci Rep. 2020 Jul 21;10(1):12028. doi: 10.1038/s41598-020-68915-1.

    PMID: 32694522BACKGROUND
  • Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.

    PMID: 24973083BACKGROUND
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    PMID: 27222591BACKGROUND
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    PMID: 30678709BACKGROUND
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    PMID: 28886621BACKGROUND
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    BACKGROUND
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    BACKGROUND
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Related Links

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Eylem Paslı Gürdoğan, Ass. Prof.

    Trakya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective (6-month follow-up), two-group (control and intervention), randomised controlled, experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2025

First Posted

March 18, 2025

Study Start

November 1, 2021

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations