The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit

Study Overview
=================
Brief 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.

Official Title
-----------------
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Behavioral: pharmaceutical care service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft. At 20-79 years of age. Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist. Willing to participate in this study. Able to be reached by telephone postdischarge. Exclusion Criteria: Patients with cognitive impairment. If they need professional help to take their medication at home. With terminal illness. Inability to communicate. Severe arrhythmia.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>will receive standard care by physician in attendance | |
| Active Comparator: intervention group<br>will be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance. | Behavioral: pharmaceutical care service<br> <br> * Other names: Comprehensive health care services;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in the number of solved drug-related problems | assessment of drug-related problems at baseline and solving them during three months | three months | 
| Assessment of medications adherence: (Eight-item Morisky adherence questionnaire). | at baseline and after three months | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of life: (36-items self-care Health survey (SF-36)). | at baseline and after three months | three months | 
| Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence). | at baseline and after three months | three months | 
| Change in heart rate [HR] (Bpm). | at baseline and after three months | three months | 
| 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 | 
| Change in levels of fasting blood glucose (mg/dl) | at baseline and after three months | three months | 
| Change in systolic and diastolic blood pressure [BP] (mmHg). | at baseline and after three months | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmaceutical care service, clinical pharmacist, Cardiac rehabilitation unit, Acute coronary syndrome, patient education and counselling