Smartphone App-assisted PPI | NCT06094062

Studies
Smartphone App-assisted PPI

NCT06094062

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Feb 13, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Heartburn
Dyspepsia

Interventions

App-based treatment support

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2023Actual

Primary Completion Date

Jan 15, 2025Actual

Completion Date

Jan 15, 2025Actual

First Submitted Date

Sep 27, 2023

First Submission Date that Met QC Criteria

Oct 18, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental		Other: App-based treatment support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Treatment extensions	Number of PPI treatment extensions including reasons and number of additional days	30 days (treatment duration)
Physicians' and pharmacists' satisfaction with the service

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle Arnet, Dr. PD	University of Basel, Pharmaceutical Care Research Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goldene Engel Apotheke		Basel	Canton of Basel-City	4001	Switzerland
TopPharm Apotheke am Spalebärg

Condition Browse Module

MeSH Terms

ID	Term
D006356	Heartburn
D004415	Dyspepsia
D055118	Medication Adherence

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010349	Patient Compliance

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