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Smartphone App-assisted PPI (PIPPI)

Primary Purpose

Heartburn, Dyspepsia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
App-based treatment support
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heartburn focused on measuring Medication Adherence, Short-term Therapy, Proton Pump Inhibitors, Mobile Health, Implementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TopPharm Apotheke am SpalebärgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Outcomes

Primary Outcome Measures

Patients with PPI treatment over 30 days
Number of patients who started and stopped a PPI after 30 days

Secondary Outcome Measures

Treatment extensions
Number of PPI treatment extensions including reasons and number of additional days
Physicians' and pharmacists' satisfaction with the service
Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews
Patients' satisfaction with the service
Patients' satisfaction with the service including the app assessed through semi-structured interviews
Reliable diagnosis after PPI treatment
Number of reliable diagnosis after short-term PPI treatment including treatment extensions

Full Information

First Posted
September 27, 2023
Last Updated
October 18, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT06094062
Brief Title
Smartphone App-assisted PPI
Acronym
PIPPI
Official Title
Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn, Dyspepsia
Keywords
Medication Adherence, Short-term Therapy, Proton Pump Inhibitors, Mobile Health, Implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
App-based treatment support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients with PPI treatment over 30 days
Description
Number of patients who started and stopped a PPI after 30 days
Time Frame
30 days (treatment duration)
Secondary Outcome Measure Information:
Title
Treatment extensions
Description
Number of PPI treatment extensions including reasons and number of additional days
Time Frame
30 days (treatment duration)
Title
Physicians' and pharmacists' satisfaction with the service
Description
Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews
Time Frame
2 weeks after study completion
Title
Patients' satisfaction with the service
Description
Patients' satisfaction with the service including the app assessed through semi-structured interviews
Time Frame
2 weeks after the end of treatment
Title
Reliable diagnosis after PPI treatment
Description
Number of reliable diagnosis after short-term PPI treatment including treatment extensions
Time Frame
After 30 days (treatment duration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Allemann, Prof
Phone
+41 61 207 61 76
Email
s.allemann@unibas.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Messner, MSc
Phone
+41 61 207 66 32
Email
kirstin.messner@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Arnet, Dr. PD
Organizational Affiliation
University of Basel, Pharmaceutical Care Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
TopPharm Apotheke am Spalebärg
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4051
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Meister
Phone
+41 61 261 42 84
Email
apotheke@am-spalebaerg.ch

12. IPD Sharing Statement

Learn more about this trial

Smartphone App-assisted PPI

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