Clinical trial NCT06094062: Smartphone App-assisted PPI
Official title: Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heartburn
Dyspepsia
Keywords: Medication Adherence
Short-term Therapy
Proton Pump Inhibitors
Mobile Health
Implementation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Patients with PPI treatment over 30 days
timeFrame: 30 days (treatment duration)
Secondary outcomes:
measure: Treatment extensions
timeFrame: 30 days (treatment duration)
measure: Physicians' and pharmacists' satisfaction with the service
timeFrame: 2 weeks after study completion
measure: Patients' satisfaction with the service
timeFrame: 2 weeks after the end of treatment
measure: Reliable diagnosis after PPI treatment
timeFrame: After 30 days (treatment duration)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Goldene Engel Apotheke
state: Basel-Stadt
city: Basel
country: Switzerland
facility: TopPharm Apotheke am Spalebärg
state: Basel-Stadt
Study officials:
affiliation: University of Basel, Pharmaceutical Care Research Group
name: Isabelle Arnet, Dr. PD
role: PRINCIPAL_INVESTIGATOR
References: