NCT05293977

Brief Summary

Objectives: To evaluate the impact of educational intervention on antibiotic short-term adherence . Methods: A prospective randomized controlled study was conducted in a tertiary hospital in Jordan. Adult patients who had an acute infection diagnosis and were prescribed antibiotic pills for short term (\< 30 day) at home were included in the study. Patients were recruited and randomly allocated into one of the two groups; control and intervention. Each patient in the intervention group was provided with pharmaceutical education about prescribed antibiotic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

January 27, 2022

Last Update Submit

March 14, 2022

Conditions

Acute Infection

Outcome Measures

Primary Outcomes (1)

  • Adherence to short-term antibiotic - measured by subjective (questions) and objective (counting remaining pills) methods.

    Two days after completing the antibiotics course regimens, patients in both groups were followed up by phone to measure adherence by asking them about i) any missing of doses/days of the prescribed antibiotics (subjective method) and ii) number of untaken/remaining pills (objective method).

    from 1 week to 4 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in the control group received routine care by the dispensing pharmacist and seen by research assistant for data collection only

Behavioral: Routine care by the dispensing pharmacist

Intervention

EXPERIMENTAL

Patient in the intervention group was verbally provided with pharmaceutical education/counseling about his/her prescribed antibiotic.

Behavioral: Pharmaceutical education/counseling about prescribed antibiotic

Interventions

Routine care by the dispensing pharmacistBEHAVIORAL

Patients in the control group received routine care by the dispensing pharmacist and seen by research assistant for data collection only

Control
Pharmaceutical education/counseling about prescribed antibioticBEHAVIORAL

Patient in the intervention group was provided with pharmaceutical education about his/her prescribed antibiotic by the trained clinical pharmacist. To prepare the education about antibiotics, the 10 most commonly prescribed antibiotics were determined in advance from hospital records: Amoxicillin or Amoxicillin/Clavulanic acid, Ciprofloxacin, Levofloxacin, Azithromycin, Cefuroxime, Cephalexin, Clindamycin, Doxycycline, Metronidazole, Trimethoprim/Sulfamethoxazole. Standard education points about antibiotics include (i) mechanism of action and/or use, (ii) correct administration method, (iii) correct timing, (iv) possible adverse effect and self-management intervention methods when faced with side effects, (v) what to do in case of missing any dose.

Intervention

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18-year-old)
  • Patient who had an acute infection diagnosis confirmed by a consultant
  • Patients who were prescribed antibiotic pills for short course treatment (\< 30 day) at home

You may not qualify if:

  • Patients who were immunocompromised
  • Patients used antibiotics for prophylactic indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (1)

  • Almomani BA, Hijazi BM, Al-Husein BA, Oqal M, Al-Natour LM. Adherence and utilization of short-term antibiotics: Randomized controlled study. PLoS One. 2023 Sep 5;18(9):e0291050. doi: 10.1371/journal.pone.0291050. eCollection 2023.

    PMID: 37669277DERIVED

Study Officials

  • Basima Almomani, PhD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

March 24, 2022

Study Start

August 3, 2020

Primary Completion

September 16, 2021

Study Completion

December 15, 2021

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations

JO(1)