Smartphone App-assisted Short-term Antibiotic Therapy (SMAPP)

January 7, 2025 updated by: University Hospital, Basel, Switzerland

Smartphone App-assisted Short-term Antibiotic Therapy - a Cluster-randomized Study in Primary Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is planned as a monocentric, cluster-randomized, double-blind, two-arm study in a primary care setting with outpatients newly prescribed co-amoxicillin for a short-term therapy. Participating community pharmacies will recruit patients entering with a prescription for co-amoxicillin and offer the service. Randomisation will take place on the pharmacy level via computer generated list of numbers (1: with intervention; 2: with no intervention). Pharmacists and participants will not know that the intervention is not the app itself, but rather the combination of a reminder and text messages (= double-blind). The intervention will consist of the use of a smartphone reminder (e.g. alarm clock or a reminder app; a list with suitable examples will be given and patients will choose one of them) and two personalized motivational and educational text messages that will be sent by the pharmacy during the treatment duration. The control group will have no reminder and no text messages. All participants will use a simplified version of the freely available medication management app TOM to record their medication intake (= adherence measurement method). Participants in both groups will obtain a consultation driven by their adherence report with the study team at the end of the treatment to discuss their individual adherence data, their symptom course and well-being. After that, patients will receive a link to an online survey where they will evaluate their satisfaction with the service and the smartphone application. Participating pharmacists will be interviewed by the study team regarding their experience and satisfaction after the end of the study.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Aargau
      • Magden, Aargau, Switzerland, 4312
        • TopPharm Hirschen Apotheke
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4058
        • Greifen Apotheke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Reminder + text messaging
Other: Smartphone medication intake reminder + educational and motivational text messaging
The intervention includes the use of a smartphone-based medication intake reminder, along with two educational and motivational text messages during the therapy period.
No Intervention: Control Group
No reminder + no text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence rates (in percent)
Time Frame: Up to 14 days (maximum therapy duration)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence rate (in percent)
Time Frame: Up to 14 days (maximum therapy duration)
Patients confirm every medication intakes in the app. The app will deliver time stamps. Based on these, persistence rate to the therapy will be calculated: [days with at least one dose / prescribed treatment days] × 100
Up to 14 days (maximum therapy duration)
Time to symptom control
Time Frame: Up to 14 days (maximum therapy duration)
Patients will note in a diary their symptoms once daily. Time to symptom control will be calculated as number of days up to freedom of symptoms.
Up to 14 days (maximum therapy duration)
Pharmacists' satisfaction with the service including the app
Time Frame: 2 weeks after study completion
Satisfaction will be assessed through semi-structured interviews and analyzed inductively.
2 weeks after study completion
Patients' satisfaction with the service including the app
Time Frame: 7 days after therapy completion
Satisfaction will be assessed quantitatively in an online-survey on a 5-point Likert-scale. High values will indicate a better outcome.
7 days after therapy completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Isabelle Arnet, Dr. PD, University of Basel, Pharmaceutical Care Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01753

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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