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Completed

NCT Number: NCT06126900

Smartphone App-assisted Short-term Antibiotic Therapy

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.

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Key information

Conditions

Infection, Bacterial Bacterial Infections Bacterial Infections and Mycoses Behavior Health Behavior Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TopPharm Hirschen Apotheke, Magden, Canton of Aargau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone medication intake reminder + educational and motivational text messaging

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: SMAPP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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