Smartphone App-assisted PPI (PIPPI)

March 7, 2024 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4051
        • Recruiting
        • TopPharm Apotheke am Spalebärg
        • Contact:
      • Basel, Basel-Stadt, Switzerland, 4001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days (treatment duration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment extensions
Time Frame: 30 days (treatment duration)
Number of PPI treatment extensions including reasons and number of additional days
30 days (treatment duration)
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
2 weeks after study completion
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
2 weeks after the end of treatment
Reliable diagnosis after PPI treatment
Time Frame: After 30 days (treatment duration)
Number of reliable diagnosis after short-term PPI treatment including treatment extensions
After 30 days (treatment duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Isabelle Arnet, Dr. PD, University of Basel, Pharmaceutical Care Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

October 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00588

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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