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

December 12, 2016 updated by: eman ahmed el-said casper, Ain Shams University
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: three months
at baseline and after three months
three months
Change in the number of solved drug-related problems
Time Frame: three months
assessment of drug-related problems at baseline and solving them during three months
three months
Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).
Time Frame: three months
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)).
Time Frame: three months
at baseline and after three months
three months
Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).
Time Frame: three months
at baseline and after three months
three months
Change in heart rate [HR] (Bpm).
Time Frame: three months
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)
Time Frame: three months
at baseline and after three months
three months
Change in levels of fasting blood glucose (mg/dl)
Time Frame: three months
at baseline and after three months
three months
Change in systolic and diastolic blood pressure [BP] (mmHg).
Time Frame: three months
at baseline and after three months
three months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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