NCT05153707

Brief Summary

To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

November 25, 2021

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30 days hospital re-admission for cardiac reasons

    Proportion of patients readmitted to hospital for cardiac cause at 1 month

    30 days

Secondary Outcomes (9)

  • Hospital re-admission for cardiac reasons

    3 months, 6 months, and 12 months

  • Hospital re-admission for any reasons

    1 month, 3 months, 6 months, and 12 months

  • Emergency service visits

    1 month, 3 months, 6 months, and 12 months

  • Major Adverse Cardiovascular Event

    1 month, 3 months, 6 months, and 12 months

  • Death for cardiac reason

    1 month, 3 months, 6 months, and 12 months

  • +4 more secondary outcomes

Study Arms (2)

Clinical Pharmacist-led discharge education program

EXPERIMENTAL

Clinical pharmacist-led services

Behavioral: Discharge Education Program

Control group

NO INTERVENTION

Usual care

Interventions

medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally \[by using Teach back method especially for patients with low health literacy\]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model).

Clinical Pharmacist-led discharge education program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the cardiology department due to acute coronary syndrome
  • Older than 18 years old

You may not qualify if:

  • Patients who transferred to another ward
  • Patients with active malignancy
  • Patients with alzheimer and/or dementia diagnosis
  • Patient with \>%80 visual loss or deaf muteness reported at medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Betul Okuyan

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 10, 2021

Study Start

January 15, 2021

Primary Completion

June 15, 2021

Study Completion

June 15, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations