Smartphone App-assisted PPI

NCT06094062 | Completed

• 1 other identifier: 2022-00588
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Heartburn; Dyspepsia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patients with PPI treatment over 30 days

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

  30 days (treatment duration)

Secondary Outcomes (4)

• Treatment extensions

  30 days (treatment duration)

• Physicians' and pharmacists' satisfaction with the service

  2 weeks after study completion

• Patients' satisfaction with the service

  2 weeks after the end of treatment

• Reliable diagnosis after PPI treatment

  After 30 days (treatment duration)

Study Arms (1)

Intervention Group

EXPERIMENTAL

Other: App-based treatment support

Interventions

App-based treatment support 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

Goldene Engel Apotheke

Basel, Canton of Basel-City, 4001, Switzerland

Location

TopPharm Apotheke am Spalebärg

Basel, Canton of Basel-City, 4051, Switzerland

Location

MeSH Terms

Conditions

Heartburn; Dyspepsia; Medication Adherence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Isabelle Arnet, Dr. PD

  University of Basel, Pharmaceutical Care Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 23, 2023
• Study Start: September 5, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 13, 2025

Record last verified: 2024-12

Locations

CH (2)