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Completed

NCT Number: NCT06094062

Smartphone App-assisted PPI

Proton pump inhibitors (PPIs) are frequently prescribed for 30 days but taken infinitely. PPIs belong to the most often inappropriate medicines (PIMs). Correct intake of medicines (named adherence) can be supported by digital devices such as smartphone applications. The goal of this interventional study is to test the feasibility of an app-based treatment support provided by community pharmacists in patients prescribed a short-term PPI (30 days). The intervention consists in tracking medication intake, symptom course and well-being over the treatment duration of 30 days with the mednet app on patients' personal smartphones.

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Key information

Conditions

Heartburn Behavior Dyspepsia Health Behavior Medication Adherence Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Signs and Symptoms, Digestive Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldene Engel Apotheke, Basel, Canton of Basel-City, Switzerland

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About this study

This is an exploratory study in a primary care setting with community pharmacists recruiting patients who are newly prescribed a PPI for a short-term treatment (30 days). There is no control group and no randomization. After informed consent and installing the app on their personal smartphones, patients will answer three questions from the app once daily. The questions address medication intake (yes/no), symptom course (better, worse, identical, no symptoms) and well-being (satisfactory/needs improvement). Worsening of symptoms will trigger an alarm (via email) at the pharmacy. The pharmacist will call the patients and use information from adherence and well-being to consolidate a supporting counseling.

Feasibility and a frequency estimation of the interventions will be the focus of the study in view of a larger implementation study with community pharmacies. Further implementation outcomes will be assessed through interviews and surveys (satisfaction, interprofessional work).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • is ≥18 years old;
  • has symptoms that suggest or correspond to gastroesophageal reflux disease (GERD);
  • is newly prescribed a short-term PPI treatment;
  • accepts to use of the smartphone app mednet during the study period;
  • signs the informed consent form;
  • understands and speaks (Swiss) German.

Exclusion criteria

  • in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.

Treatment and study plan

App-based treatment support

Other

The intervention includes a smartphone app that patients will download on their smartphones. Medication intake, symptom course and well-being will be tracked over treatment duration. If symptoms worsen, the pharmacist will contact the patients and counsel them based on their adherence and well-being data. Patients who still have symptoms after the 30 days of treatment will receive a final counseling by the pharmacy, and if necessary will be forwarded to the treating physician.

Primary outcomes

  1. Patients with PPI treatment over 30 days

    Time frame: 30 days (treatment duration)

    Number of patients who started and stopped a PPI after 30 days

Secondary outcomes

  1. Treatment extensions

    Time frame: 30 days (treatment duration)

    Number of PPI treatment extensions including reasons and number of additional days

  2. Physicians' and pharmacists' satisfaction with the service

    Time frame: 2 weeks after study completion

    Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews

  3. Patients' satisfaction with the service

    Time frame: 2 weeks after the end of treatment

    Patients' satisfaction with the service including the app assessed through semi-structured interviews

  4. Reliable diagnosis after PPI treatment

    Time frame: After 30 days (treatment duration)

    Number of reliable diagnosis after short-term PPI treatment including treatment extensions

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study

Acronym: PIPPI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Feb 13, 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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