NCT06126900

Brief Summary

Outpatients with short-term antibiotic treatment should start and finish the treatment according to medical advise that is, the intake pattern (named adherence) should be regular. The research question is: Can a smartphone-based program including intake reminder and two text messages improve adherence to a short-term antibiotic treatment in ambulatory setting? Participants will be asked to record every antibiotic intake in an app on their smartphone over the prescribed therapy duration and to note their symptoms once daily. One group will obtain reminder + text messages, and the control group will have no reminder + no text messages.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 17, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

October 17, 2023

Last Update Submit

January 7, 2025

Conditions

Infection, Bacterial

Keywords

Medication AdherenceShort-term therapyAnti-Bacterial AgentsMobile Health

Outcome Measures

Primary Outcomes (1)

  • Adherence rates (in percent)

    Patients confirm every medication intakes in the app. The app will deliver time stamps. Based on these, taking, dosing and timing adherence will be calculated in percent.

    Up to 14 days (maximum therapy duration)

Secondary Outcomes (4)

  • Persistence rate (in percent)

    Up to 14 days (maximum therapy duration)

  • Time to symptom control

    Up to 14 days (maximum therapy duration)

  • Pharmacists' satisfaction with the service including the app

    2 weeks after study completion

  • Patients' satisfaction with the service including the app

    7 days after therapy completion

Study Arms (2)

Intervention Group

EXPERIMENTAL

Reminder + text messaging

Other: Smartphone medication intake reminder + educational and motivational text messaging

Control Group

NO INTERVENTION

No reminder + no text messaging

Interventions

Smartphone medication intake reminder + educational and motivational text messagingOTHER

The intervention includes the use of a smartphone-based medication intake reminder, along with two educational and motivational text messages during the therapy period.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • is min. 18 years old;
  • is newly prescribed a co-amoxicillin treatment of 3-14 days;
  • has symptoms that correspond to bacterial infection;
  • accepts to use of one of the medication adherence application with reminder function from the provided list;
  • accepts to use of the electronic monitoring application TOM™ during the study period;
  • is capable of using the TOM™ application;
  • signs the informed consent form;
  • understands and speaks (Swiss) German.

You may not qualify if:

  • in the opinion of the pharmacists, unlikely to comply with the study schedule or are unsuitable for any other reason.
  • does not manage medication himself/herself
  • already using a medication intake reminder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TopPharm Hirschen Apotheke

Magden, Canton of Aargau, 4312, Switzerland

Location

Greifen Apotheke

Basel, Canton of Basel-City, 4058, Switzerland

Location

MeSH Terms

Conditions

Bacterial InfectionsMedication Adherence

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Isabelle Arnet, Dr. PD

    University of Basel, Pharmaceutical Care Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

November 13, 2023

Study Start

January 15, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

CH(2)