Clinical trial NCT02922140: The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
Official title: The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: pharmaceutical care service, clinical pharmacist
Cardiac rehabilitation unit
Acute coronary syndrome
patient education and counselling
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q)
timeFrame: three months
measure: Change in the number of solved drug-related problems
timeFrame: three months
measure: Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).
timeFrame: three months
Secondary outcomes:
measure: Assessment of quality of life: (36-items self-care Health survey (SF-36)).
timeFrame: three months
measure: Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).
timeFrame: three months
measure: Change in heart rate [HR] (Bpm).
timeFrame: three months
measure: Change in Lipid profile : total cholesterol (mg/dl), triglycerides(mg/dl), and low density lipoprotein cholesterol(mg/dl), high density lipoprotein (mg/dl)
timeFrame: three months
measure: Change in levels of fasting blood glucose (mg/dl)
timeFrame: three months
measure: Change in systolic and diastolic blood pressure [BP] (mmHg).
timeFrame: three months
Other outcomes:
measure: Change in potassium (mmol/l).
timeFrame: three months
measure: Change in sodium (mmol/l).
timeFrame: three months
measure: Change in serum creatinine (mg/dl).
timeFrame: three months
measure: Change in waist circumference (cm).
timeFrame: three months
measure: Change in Liver function tests: aspartate aminotransferase enzyme (AST) (u/l), alanine aminotransferase (ALT) (u/l)
timeFrame: three months
measure: Change in Kidney function tests : serum urea (mg/dl).
timeFrame: three months
measure: Change in anthropometric measurements (body mass index [BMI] (Kg/m^2))
timeFrame: three months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Eman A. Casper, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.