Smartphone App-assisted PPI

Dyspepsia Clinical Trial

— PIPPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094062
• Other study ID #: 2022-00588
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Samuel Allemann, Prof
• Phone: +41 61 207 61 76
• Email: s.allemann[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Heartburn

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Goldene Engel Apotheke	Basel	Basel-Stadt
Switzerland	TopPharm Apotheke am Spalebärg	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with PPI treatment over 30 days	Number of patients who started and stopped a PPI after 30 days	30 days (treatment duration)
Secondary	Treatment extensions	Number of PPI treatment extensions including reasons and number of additional days	30 days (treatment duration)
Secondary	Physicians' and pharmacists' satisfaction with the service	Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews	2 weeks after study completion
Secondary	Patients' satisfaction with the service	Patients' satisfaction with the service including the app assessed through semi-structured interviews	2 weeks after the end of treatment
Secondary	Reliable diagnosis after PPI treatment	Number of reliable diagnosis after short-term PPI treatment including treatment extensions	After 30 days (treatment duration)