NCT06313619

Brief Summary

We developed 'SmartAMR', a digital pharmacy system featuring real-time records, symptom checks, telemedicine, counselling, and medication reminders. This study aims to assess its feasibility, acceptability, and effectiveness within community pharmacy settings in Bangladesh. A before-after designed pilot quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample. For qualitative part, the sample will be selected purposively until data saturation and a total of 8 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding effectiveness, acceptability, adoption, feasibility, and cost of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 25, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

November 25, 2023

Last Update Submit

August 30, 2025

Conditions

Keywords

Anti-microbial resistanceDigital interventionIrrational use

Outcome Measures

Primary Outcomes (6)

  • Irrational usage of anti-microbials

    Irrational usage of anti-microbials was demonstrated by number and pattern of purchasing of anti-microbials

    12 weeks

  • Acceptance rate

    Number of pharmacy agreed and accepted the intervention and install the mobile app.

    12 weeks

  • Completion rate

    The number of pharmacy who use the mobile app for the total duration of intervention.

    12 weeks

  • AMR Knowledge

    Change in knowledge about antimicrobial resistance among the participants was assessed using a knowledge scale "AMR knowledge scale" that contained 31 questions. The score range will be 0 to 31, with greater score representing better knowledge.

    Before and 12 weeks after the intervention

  • AMR attitude

    Participants' attitude towards antimicrobial resistance was evaluated by a three-point Likert-type scale "AMR attitude scale", containing 14 attitude statements. The score range will be 14 to 42, with greater score representing better knowledge.

    Before and 12 weeks after the intervention

  • AMR practice

    Participants' practice regarding irrational antimicrobial usage is assessed by a practice scale "AMR practice scale", containing 9 items. Answers to the practice questions are taken on a rating scale (0=never; 1 = rarely; 2 = sometimes; 3 = frequently). Practice score ranges from 0 to 27. Higher score indicates better practice.

    Before and 12 weeks after the intervention

Study Arms (1)

Digital Pharmacy Intervention

EXPERIMENTAL

A total of 39 pharmacy will be included in the intervention. The digital intervention named "SmartAMR" will be introduced among them. The participants will install the mobile app and use it to keep record of the antimicrobial sales in a central database.

Combination Product: SmartAMR

Interventions

SmartAMRCOMBINATION_PRODUCT

"SmartAMR" is a digital system including a mobile app that helps keeping record of medicine sales, sending auto-generated messages to the consumers to remind them about medicine taking time and completing doses. It also poses a symptom checker driven by artificial intelligence and a telemedicine service.

Digital Pharmacy Intervention

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and above
  • Registered drug seller/pharmacist
  • Permanent residents of the study areas
  • Willing to participate

You may not qualify if:

  • Disoriented or critically ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Study Officials

  • M Atiqul Haque, PhD

    Bangladesh Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A single group of pharmacy drug sellers were trained on using a digital pharmacy management system including record keeping, AI symptom checker, telemedicine services, counselling, and SMS reminder for dose completion.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2023

First Posted

March 15, 2024

Study Start

October 23, 2023

Primary Completion

April 30, 2024

Study Completion

October 31, 2024

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations