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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02922140
• Other study ID #: PHCL49
• 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

• Acute Coronary Syndrome

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