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Disease Management for Coronary Artery Patients

The Effect of Training Given to Coronary Artery Patients on Disease Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04556006
Enrollment
58
Registered
2020-09-21
Start date
2019-03-01
Completion date
2020-03-30
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Patient Empowerment

Keywords

Training, Disease Management, Nursing, Coronary Artery Disease, Compliance

Brief summary

This randomized controlled trial was conducted with 58 patients hospitalized in the cardiology clinic of a state hospital. Personal Information Form, Anthropometric measurements, Framingham risk score, and compliance questionnaire (CQ) were used to collect the data.

Interventions

OTHERPatient education

The data collection process of the study was carried out in two stages using data collection tools. First stage: Personal Information Form and Compliance Questionnaire were applied to all patients in both groups. After anthropometric measurements, Framingham Risk Score was determined. The data collection forms were filled with the patients using face-to-face interview technique. The data collection process lasted for approximately 10-15 minutes. After the data collection, the patients in the intervention group were trained. No training was given to the patients in the control group but they received a Coronary Artery Disease Management Guide. Second stage: 12 weeks after the first interview, the patients were interviewed again face-to-face interview technique and the forms and measurements applied initially were repeated.

Sponsors

Kilis 7 Aralik University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

Single blinded

Intervention model description

Single blinded, randomised-control study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* aged 18 and over, * diagnosed with coronary artery disease for at least 2 months, * no hearing and vision problem, * no perception and expression deficiency, * not diagnosed with any psychiatric disease, * living in Kilis province, * voluntary to participate in the study.

Exclusion criteria

* aged 18 under, * diagnosed without coronary artery disease for at least 2 months, * hearing and vision problem, * perception and expression deficiency, * diagnosed with any psychiatric disease, * no living in Kilis province, * no voluntary to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Compliance Questionnaire Scores of the ParticipantsInitially-12 weeksCompliance Questionnaire is a form allowing to investigate 11 different areas such as the use of medication causing maladaptation in disease management in individuals with chronic illnesses, diet, weight loss, limiting physical activity, exercise, coping with stress, alcohol use, smoking, sexual activity problems, caffeine intake and working/job life. In the form allowing Likert-type evaluation, the participant is expected to select one of the options 0 (never), 1 (very rarely), 2 (sometimes), 3 (most of the time) or 4 (always) while expressing his/her compliance level for each adaptation area. The scores corresponding to the given expression are summed and Compliance Questionnaire score for each participant is determined. The score range that can be obtained for each subscale is 0-4. The Compliance Questionnaire total scores is between 0-44. High scores mean a better as it an increase in the compliance level to the disease.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Control
The patients in the control group received only the standard care provided by the clinicians. After the collection of post-test data, the content of the training was also explained to these patients and the study was completed by giving them the training guide.
28
Intervention
After the data collection, the patients in the intervention group were trained. The training programme is not only more structured training than the standard care programme but also includes patient follow-up at certain periods. Thus, the effect of the given education and follow-up on patient behaviour is monitored. The training programme is consist of information about disease, treatment process, risk factors and coping mechanisms.
30
Total58

Baseline characteristics

CharacteristicControlInterventionTotal
Age, Continuous60.21 years
STANDARD_DEVIATION 11.46
56.83 years
STANDARD_DEVIATION 10.74
58.46 years
STANDARD_DEVIATION 10.84
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
11 Participants12 Participants23 Participants
Sex: Female, Male
Male
17 Participants18 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Compliance Questionnaire Scores of the Participants

Compliance Questionnaire is a form allowing to investigate 11 different areas such as the use of medication causing maladaptation in disease management in individuals with chronic illnesses, diet, weight loss, limiting physical activity, exercise, coping with stress, alcohol use, smoking, sexual activity problems, caffeine intake and working/job life. In the form allowing Likert-type evaluation, the participant is expected to select one of the options 0 (never), 1 (very rarely), 2 (sometimes), 3 (most of the time) or 4 (always) while expressing his/her compliance level for each adaptation area. The scores corresponding to the given expression are summed and Compliance Questionnaire score for each participant is determined. The score range that can be obtained for each subscale is 0-4. The Compliance Questionnaire total scores is between 0-44. High scores mean a better as it an increase in the compliance level to the disease.

Time frame: Initially-12 weeks

ArmMeasureValue (MEAN)Dispersion
ControlCompliance Questionnaire Scores of the Participants22.25 score on a scaleStandard Deviation 7.02
İnterventionCompliance Questionnaire Scores of the Participants22.53 score on a scaleStandard Deviation 5.48

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026