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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02922140
Other study ID # PHCL49
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 20, 2016
Last updated December 12, 2016
Start date September 2015
Est. completion date August 2017

Study information

Verified date December 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial Summary

This study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with Acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or cardiac events.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

1. Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft.

2. At 20-79 years of age.

3. Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist.

4. Willing to participate in this study.

5. Able to be reached by telephone postdischarge.

Exclusion Criteria:

1. Patients with cognitive impairment.

2. If they need professional help to take their medication at home.

3. With terminal illness.

4. Inability to communicate.

5. Severe arrhythmia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
pharmaceutical care service


Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (2)

Lead Sponsor Collaborator
Ain Shams University Ain Shams university hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in potassium (mmol/l). at baseline and after three months three months Yes
Other Change in sodium (mmol/l). at baseline and after three months three months Yes
Other Change in serum creatinine (mg/dl). at baseline and after three months three months Yes
Other Change in waist circumference (cm). at baseline and after three months three months No
Other Change in Liver function tests: aspartate aminotransferase enzyme (AST) (u/l), alanine aminotransferase (ALT) (u/l) at baseline and after three months three months Yes
Other Change in Kidney function tests : serum urea (mg/dl). at baseline and after three months three months Yes
Other Change in anthropometric measurements (body mass index [BMI] (Kg/m^2)) at baseline and after three months three months No
Primary Change in the level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q) at baseline and after three months three months No
Primary Change in the number of solved drug-related problems assessment of drug-related problems at baseline and solving them during three months three months No
Primary Assessment of medications adherence: (Eight-item Morisky adherence questionnaire). at baseline and after three months three months No
Secondary Assessment of quality of life: (36-items self-care Health survey (SF-36)). at baseline and after three months three months No
Secondary Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence). at baseline and after three months three months No
Secondary Change in heart rate [HR] (Bpm). at baseline and after three months three months No
Secondary Change in Lipid profile : total cholesterol (mg/dl), triglycerides(mg/dl), and low density lipoprotein cholesterol(mg/dl), high density lipoprotein (mg/dl) at baseline and after three months three months No
Secondary Change in levels of fasting blood glucose (mg/dl) at baseline and after three months three months No
Secondary Change in systolic and diastolic blood pressure [BP] (mmHg). at baseline and after three months three months No
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