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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922140
Recruitment Status : Unknown
Verified December 2016 by eman ahmed el-said casper, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
eman ahmed el-said casper, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Behavioral: pharmaceutical care service Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
Study Start Date : September 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. Assessment of medications adherence: (Eight-item Morisky adherence questionnaire). [ Time Frame: three months ]
    at baseline and after three months


Secondary Outcome Measures :
  1. Assessment of quality of life: (36-items self-care Health survey (SF-36)). [ Time Frame: three months ]
    at baseline and after three months

  2. 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

  3. Change in heart rate [HR] (Bpm). [ Time Frame: three months ]
    at baseline and after three months

  4. 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

  5. Change in levels of fasting blood glucose (mg/dl) [ Time Frame: three months ]
    at baseline and after three months

  6. Change in systolic and diastolic blood pressure [BP] (mmHg). [ Time Frame: three months ]
    at baseline and after three months


Other Outcome Measures:
  1. Change in potassium (mmol/l). [ Time Frame: three months ]
    at baseline and after three months

  2. Change in sodium (mmol/l). [ Time Frame: three months ]
    at baseline and after three months

  3. Change in serum creatinine (mg/dl). [ Time Frame: three months ]
    at baseline and after three months

  4. Change in waist circumference (cm). [ Time Frame: three months ]
    at baseline and after three months

  5. 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

  6. Change in Kidney function tests : serum urea (mg/dl). [ Time Frame: three months ]
    at baseline and after three months

  7. Change in anthropometric measurements (body mass index [BMI] (Kg/m^2)) [ Time Frame: three months ]
    at baseline and after three months



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922140


Locations
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Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Eman A. Casper, bachelor Ain Shams University

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Responsible Party: eman ahmed el-said casper, Teaching Assisstant, Ain Shams University
ClinicalTrials.gov Identifier: NCT02922140    
Other Study ID Numbers: PHCL49
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by eman ahmed el-said casper, Ain Shams University:
pharmaceutical care service, clinical pharmacist
Cardiac rehabilitation unit
Acute coronary syndrome
patient education and counselling
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases