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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556006
Other study ID # Kilis7AralikU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date March 30, 2020

Study information

Verified date September 2020
Source Kilis 7 Aralik University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date March 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- aged 18 and over,

- diagnosed with CAD 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 CAD 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.

Study Design


Intervention

Other:
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, FR 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.

Locations

Country Name City State
Turkey Kilis 7 Aralik University Kilis

Sponsors (1)

Lead Sponsor Collaborator
Kilis 7 Aralik University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bitton A, Choudhry NK, Matlin OS, Swanton K, Shrank WH. The impact of medication adherence on coronary artery disease costs and outcomes: a systematic review. Am J Med. 2013 Apr;126(4):357.e7-357.e27. doi: 10.1016/j.amjmed.2012.09.004. Review. — View Citation

Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith — View Citation

Kurçer MA, Ozbay A. [Effects of patient education and counseling about life style on quality of life in patients with coronary artery disease]. Anadolu Kardiyol Derg. 2011 Mar;11(2):107-13. doi: 10.5152/akd.2011.028. Epub 2011 Feb 2. Turkish. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CQ scores of the participants Compliance Questionnaire (CQ) 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 CQ score for each participant is determined. The maximum score is 44. High score signifies an increase in the compliance level to the disease.
Initially-12 weeks
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