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

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

pharmaceutical care service

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring pharmaceutical care service, clinical pharmacist, Cardiac rehabilitation unit, Acute coronary syndrome, patient education and counselling

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft.
At 20-79 years of age.
Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist.
Willing to participate in this study.
Able to be reached by telephone postdischarge.

Exclusion Criteria:

Patients with cognitive impairment.
If they need professional help to take their medication at home.
With terminal illness.
Inability to communicate.
Severe arrhythmia.

Sites / Locations

Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

intervention group

Arm Description

will receive standard care by physician in attendance

will be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance.

Outcomes

Primary Outcome Measures

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

Change in the number of solved drug-related problems

assessment of drug-related problems at baseline and solving them during three months

Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).

at baseline and after three months

Secondary Outcome Measures

Assessment of quality of life: (36-items self-care Health survey (SF-36)).

at baseline and after three months

Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).

at baseline and after three months

Change in heart rate [HR] (Bpm).

at baseline and after 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

Change in levels of fasting blood glucose (mg/dl)

at baseline and after three months

Change in systolic and diastolic blood pressure [BP] (mmHg).

at baseline and after three months

Full Information

NCT ID

NCT02922140

First Posted

September 20, 2016

Last Updated

December 12, 2016

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02922140

Brief Title

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

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

pharmaceutical care service, clinical pharmacist, Cardiac rehabilitation unit, Acute coronary syndrome, patient education and counselling

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

will receive standard care by physician in attendance

Arm Title

intervention group

Arm Type

Active Comparator

Arm Description

will be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance.

Intervention Type

Behavioral

Intervention Name(s)

pharmaceutical care service

Other Intervention Name(s)

pharmaceutical care plan, Comprehensive health care services

Primary Outcome Measure Information:

Title

Change in the level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q)

Description

at baseline and after three months

Time Frame

three months

Title

Change in the number of solved drug-related problems

Description

assessment of drug-related problems at baseline and solving them during three months

Time Frame

three months

Title

Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).

Description

at baseline and after three months

Time Frame

three months

Secondary Outcome Measure Information:

Title

Assessment of quality of life: (36-items self-care Health survey (SF-36)).

Description

at baseline and after three months

Time Frame

three months

Title

Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).

Description

at baseline and after three months

Time Frame

three months

Title

Change in heart rate [HR] (Bpm).

Description

at baseline and after three months

Time Frame

three months

Title

Change in Lipid profile : total cholesterol (mg/dl), triglycerides(mg/dl), and low density lipoprotein cholesterol(mg/dl), high density lipoprotein (mg/dl)

Description

at baseline and after three months

Time Frame

three months

Title

Change in levels of fasting blood glucose (mg/dl)

Description

at baseline and after three months

Time Frame

three months

Title

Change in systolic and diastolic blood pressure [BP] (mmHg).

Description

at baseline and after three months

Time Frame

three months

Other Pre-specified Outcome Measures:

Title

Change in potassium (mmol/l).

Description

at baseline and after three months

Time Frame

three months

Title

Change in sodium (mmol/l).

Description

at baseline and after three months

Time Frame

three months

Title

Change in serum creatinine (mg/dl).

Description

at baseline and after three months

Time Frame

three months

Title

Change in waist circumference (cm).

Description

at baseline and after three months

Time Frame

three months

Title

Change in Liver function tests: aspartate aminotransferase enzyme (AST) (u/l), alanine aminotransferase (ALT) (u/l)

Description

at baseline and after three months

Time Frame

three months

Title

Change in Kidney function tests : serum urea (mg/dl).

Description

at baseline and after three months

Time Frame

three months

Title

Change in anthropometric measurements (body mass index [BMI] (Kg/m^2))

Description

at baseline and after three months

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft. At 20-79 years of age. Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist. Willing to participate in this study. Able to be reached by telephone postdischarge. Exclusion Criteria: Patients with cognitive impairment. If they need professional help to take their medication at home. With terminal illness. Inability to communicate. Severe arrhythmia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eman A. Casper, bachelor

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ain Shams University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35701314

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.

Results Reference

derived

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

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