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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: pharmaceutical care service

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; will receive standard care by physician in attendance
Active Comparator: intervention group; will be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance.	Behavioral: pharmaceutical care service; Other Names: pharmaceutical care plan; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in potassium (mmol/l).	at baseline and after three months	three months
Change in sodium (mmol/l).	at baseline and after three months	three months
Change in serum creatinine (mg/dl).	at baseline and after three months	three months
Change in waist circumference (cm).	at baseline and after three months	three months
Change in Liver function tests: aspartate aminotransferase enzyme (AST) (u/l), alanine aminotransferase (ALT) (u/l)	at baseline and after three months	three months
Change in Kidney function tests : serum urea (mg/dl).	at baseline and after three months	three months
Change in anthropometric measurements (body mass index [BMI] (Kg/m^2))	at baseline and after three months	three months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Eman A. Casper, bachelor, Ain Shams University

Publications and helpful links

General Publications

• Ahmed Casper E, Mohmed El Wakeel L, Ayman Saleh M, Hamed El-Hamamsy M. The impact of a comprehensive pharmaceutical care intervention in addition to cardiac rehabilitation program on outcomes of post-acute coronary syndrome patients: A pilot study. Patient Educ Couns. 2022 Oct;105(10):3164-3168. doi: 10.1016/j.pec.2022.06.004. Epub 2022 Jun 10.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; pharmaceutical care service, clinical pharmacist; Cardiac rehabilitation unit; patient education and counselling
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: PHCL49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED