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CompletedNCT06094062PIPPIUpdated Feb 13, 2025

Smartphone App-assisted PPI

An interventional study of App-based treatment support in Heartburn and Dyspepsia, 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 2025-02-13.

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Heartburn
  • Dyspepsia

Keywords

  • Medication Adherence
  • Short-term Therapy
  • Proton Pump Inhibitors
  • Mobile Health
  • Implementation
03

In context

Heartburn

154 studies on the registry are indexed under Heartburn; 12 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 127 interventional studies indexed under Heartburn.

Browse Heartburn studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form;
  • understands and speaks (Swiss) German.

Exclusion criteria

Exclusion Criteria:

  • in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Other: App-based treatment support

Interventions

  • OtherApp-based treatment support

    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.

06

What researchers measure

Primary outcomes

  1. Patients with PPI treatment over 30 days

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

    Time frame: 30 days (treatment duration)

Secondary outcomes

  1. Treatment extensions

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

    Time frame: 30 days (treatment duration)

  2. Physicians' and pharmacists' satisfaction with the service

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

    Time frame: 2 weeks after study completion

  3. Patients' satisfaction with the service

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

    Time frame: 2 weeks after the end of treatment

  4. Reliable diagnosis after PPI treatment

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

    Time frame: After 30 days (treatment duration)

07

Study locations

2 sites
  • Goldene Engel Apotheke
    Basel, Basel-Stadt 4001, Switzerland
  • TopPharm Apotheke am Spalebärg
    Basel, Basel-Stadt 4051, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06094062
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Sep 5, 2023
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025
Last update
Feb 13, 2025

Study contacts

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

Oversight

Data monitoring committee
No
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 Dec 2024. You cannot join it, but the record below documents what was studied.

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