Trial Outcomes & Findings for Disease Management for Coronary Artery Patients (NCT NCT04556006)
NCT ID: NCT04556006
Last Updated: 2024-08-21
Results Overview
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.
COMPLETED
NA
58 participants
Initially-12 weeks
2024-08-21
Participant Flow
Participant milestones
| Measure |
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.
|
Intervention
The training program was applied by the researcher who also work as an academic nurse. The contact information of the patients was obtained and the contact information of the researcher was also given to the patients. In order to consolidate the information given, the training guide was given to the patients in the intervention group. After the training, the patients in the intervention group were contacted again in the 2nd week by using face-to-face interview and in the 4th-8th and 12th weeks by phone calls. In the last interview, an appointment day was determined to meet face-to-face at home, workplaces or hospital according to the preferences of the patients.
Patient education: The data collection process of the study was carried out in two stages using data collection tools.
First stage: The forms 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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=28 Participants
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.
|
Intervention
n=30 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.21 years
STANDARD_DEVIATION 11.46 • n=28 Participants
|
56.83 years
STANDARD_DEVIATION 10.74 • n=30 Participants
|
58.46 years
STANDARD_DEVIATION 10.84 • n=58 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=28 Participants
|
12 Participants
n=30 Participants
|
23 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=28 Participants
|
18 Participants
n=30 Participants
|
35 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Initially-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.
Outcome measures
| Measure |
Control
n=28 Participants
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.
|
İntervention
n=30 Participants
The contact information of the patients was obtained and the contact information of the researcher was also given to the patients. In order to consolidate the information given, the training guide was given to the patients in the intervention group. After the training, the patients in the intervention group were contacted again in the 2nd week by using face-to-face interview and in the 4th-8th and 12th weeks by phone calls. In the last interview, an appointment day was determined to meet face-to-face at home, workplaces or hospital according to the preferences of the patients.
Patient 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.
|
|---|---|---|
|
Compliance Questionnaire Scores of the Participants
|
22.25 score on a scale
Standard Deviation 7.02
|
22.53 score on a scale
Standard Deviation 5.48
|
Adverse Events
Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place