Smartphone App-assisted PPI

Not Applicable

Completed

• Conditions: Dyspepsia; Heartburn
• Interventions: Other: App-based treatment support

• Registration Number: NCT06094062
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

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).

Study Timeline

• Study Start: 2023-09-05
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Status Verified: 2024-12
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	App-based treatment support	-

Primary Outcome Measures

Name	Time	Method
Patients with PPI treatment over 30 days	30 days (treatment duration)	Number of patients who started and stopped a PPI after 30 days

Secondary Outcome Measures

Name	Time	Method
Physicians' and pharmacists' satisfaction with the service	2 weeks after study completion	Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews
Patients' satisfaction with the service	2 weeks after the end of treatment	Patients' satisfaction with the service including the app assessed through semi-structured interviews
Treatment extensions	30 days (treatment duration)	Number of PPI treatment extensions including reasons and number of additional days
Reliable diagnosis after PPI treatment	After 30 days (treatment duration)	Number of reliable diagnosis after short-term PPI treatment including treatment extensions

Trial Locations

Locations (2)

Goldene Engel Apotheke; 🇨🇭 Basel, Basel-Stadt, Switzerland

TopPharm Apotheke am Spalebärg; 🇨🇭 Basel, Basel-Stadt, Switzerland