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CompletedNCT06126900SMAPPUpdated Jan 9, 2025

Smartphone App-assisted Short-term Antibiotic Therapy

An interventional study of Smartphone medication intake reminder + educational and motivational text messaging in Infection, Bacterial, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infection, Bacterial

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Keywords

  • Medication Adherence
  • Short-term therapy
  • Anti-Bacterial Agents
  • Mobile Health
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 34 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Reminder + text messaging

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

  • No intervention
    Control Group

    No reminder + no text messaging

Interventions

  • OtherSmartphone 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.

06

What researchers measure

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.

    Time frame: Up to 14 days (maximum therapy duration)

Secondary outcomes

  1. Persistence rate (in percent)

    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

    Time frame: Up to 14 days (maximum therapy duration)

  2. Time to symptom control

    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.

    Time frame: Up to 14 days (maximum therapy duration)

  3. Pharmacists' satisfaction with the service including the app

    Satisfaction will be assessed through semi-structured interviews and analyzed inductively.

    Time frame: 2 weeks after study completion

  4. Patients' satisfaction with the service including the app

    Satisfaction will be assessed quantitatively in an online-survey on a 5-point Likert-scale. High values will indicate a better outcome.

    Time frame: 7 days after therapy completion

07

Study locations

2 sites
  • TopPharm Hirschen Apotheke
    Magden, Aargau 4312, Switzerland
  • Greifen Apotheke
    Basel, Basel-Stadt 4058, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06126900
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Jan 15, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jan 9, 2025

Study contacts

Isabelle Arnet, Dr. PD
principal investigator · University of Basel, Pharmaceutical Care Research Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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