NCT02922140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

September 20, 2016

Last Update Submit

December 12, 2016

Conditions

Acute Coronary Syndrome

Keywords

pharmaceutical care service, clinical pharmacistCardiac rehabilitation unitAcute coronary syndromepatient education and counselling

Outcome Measures

Primary Outcomes (3)

  • 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

  • Change in the number of solved drug-related problems

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

    three months

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

    at baseline and after three months

    three months

Secondary Outcomes (6)

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

    three months

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

    three months

  • Change in heart rate [HR] (Bpm).

    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)

    three months

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

    three months

  • +1 more secondary outcomes

Other Outcomes (7)

  • Change in potassium (mmol/l).

    three months

  • Change in sodium (mmol/l).

    three months

  • Change in serum creatinine (mg/dl).

    three months

  • +4 more other outcomes

Study Arms (2)

control group

NO INTERVENTION

will receive standard care by physician in attendance

intervention group

ACTIVE COMPARATOR

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

Behavioral: pharmaceutical care service

Interventions

pharmaceutical care serviceBEHAVIORAL
Also known as: pharmaceutical care plan, Comprehensive health care services
intervention group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35701314DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eman A. Casper, bachelor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assisstant

Study Record Dates

First Submitted

September 20, 2016

First Posted

October 4, 2016

Study Start

September 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

EG(1)