Smartphone App-assisted PPI

NCT ID: NCT06094062

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2025-01-15

Brief Summary

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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

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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).

Conditions

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Heartburn Dyspepsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

App-based treatment support

Intervention Type 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.

Interventions

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App-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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Arnet, Dr. PD

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Pharmaceutical Care Research Group

Locations

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Goldene Engel Apotheke

Basel, Canton of Basel-City, Switzerland

Site Status

TopPharm Apotheke am Spalebärg

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-00588

Identifier Type: -

Identifier Source: org_study_id

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