NCT05954819

Brief Summary

The purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

July 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

18 days

First QC Date

July 6, 2023

Last Update Submit

October 2, 2023

Conditions

Keywords

DiabetesPatient educationDiabetes self-managementMyocardial infarctionHealthy lifestyle behaviors

Outcome Measures

Primary Outcomes (2)

  • Change of Healthy Lifestyle Behaviors

    The Healthy Lifestyle Behaviors Scale, which consists of 52 items, has a total of 6 sub-dimensions: spiritual development, health responsibility, physical activity, nutrition, spiritual development, interpersonal relations and stress management.The overall score of the scale gives the healthy lifestyle behaviors score.

    Change from Baseline Healthy Lifestyle Behaviors at 4 Weeks

  • Change of Diabetes Self-Management

    The Diabetes Self-Management Scale, which consists of 19 questions in the scale that evaluate self-management in patients with type 2 diabetes. High scores on the scale indicate good self-management, and low scores indicate poor self-management.

    Change from Baseline Diabetes Self-Management at 4 Weeks

Study Arms (2)

Planned patient education

EXPERIMENTAL

Pre-test data will be obtained by using the "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". The participants will be individual education on myocardial infarction and diabetes by researcher. One month later, the posttest data will be obtained using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale".

Other: Planned patient education

Routine patient education

NO INTERVENTION

Pre-test data will be obtained by using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". No attempt will be made to participants by the researcher. Participants will undergo discharge training routinely administered by bedside nurses at the hospital. One month later, the posttest data will be obtained using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale".

Interventions

Patients in the experimental group will be given about 30 minutes of patient education. After the training, a Patient Education Booklet containing Myocardial Infarction and Diabetes Education will be presented to the patients. Control group patients will not be given any training other than the hospital routine.

Planned patient education

Eligibility Criteria

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

You may qualify if:

  • years or older,
  • No advanced hearing and vision problems,
  • Able to speak and understand Turkish,
  • Easy to communicate,
  • Literate,
  • Agreeing to participate in the research voluntarily,
  • Hospitalized due to myocardial infarction in the last month,
  • Have stayed in the intensive care unit for at least 24 hours,
  • No chest pain
  • Patients who have been diagnosed with Type 2 Diabetes Mellitus for at least one year

You may not qualify if:

  • Sedative or narcotic analgesic drug treatment,
  • Use of antipsychotic medication
  • Patients receiving Continous Positive Airway Pressure treatment,
  • Patients with cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing

Istanbul, 34381, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Myocardial InfarctionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Arzu Erkoc

    Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 20, 2023

Study Start

July 28, 2023

Primary Completion

August 15, 2023

Study Completion

September 15, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

This study is planned as a master's thesis. Data can be shared after the thesis is completed.

Time Frame
The data will become available after two years.
Access Criteria
Criteria is to refer to this study.

Locations