HeartburnPIPPINCT06094062
Smartphone App-assisted PPI
A study testing App-based treatment support in people with Heartburn and Dyspepsia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- App-based treatment support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 5 Sep 2023to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Goldene Engel Apotheke
Basel, Canton of Basel-City, 4001
TopPharm Apotheke am Spalebärg
Basel, Canton of Basel-City, 4051
About this study
Official title: Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study
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.
Read the 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).
- Being tested
- App-based treatment support
- Keywords
- Medication Adherence, Short-term Therapy, Proton Pump Inhibitors, Mobile Health, Implementation
- Medical subject headings
- Heartburn, Dyspepsia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based treatment supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: App-based treatment support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with PPI treatment over 30 days
Number of patients who started and stopped a PPI after 30 days
Measured: 30 days (treatment duration)
Secondary outcomes (4)
Treatment extensions
Number of PPI treatment extensions including reasons and number of additional days
Measured: 30 days (treatment duration)
Physicians' and pharmacists' satisfaction with the service
Physicians' and pharmacists satisfaction with the service including adherence report assessed through semi-structured interviews
Measured: 2 weeks after study completion
Patients' satisfaction with the service
Patients' satisfaction with the service including the app assessed through semi-structured interviews
Measured: 2 weeks after the end of treatment
Reliable diagnosis after PPI treatment
Number of reliable diagnosis after short-term PPI treatment including treatment extensions
Measured: After 30 days (treatment duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start5 Sep 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Arnet, Dr. PD, Principal investigator, University of Basel, Pharmaceutical Care Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094062
- Sponsor's protocol ID
- 2022-00588
- Acronym
- PIPPI
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study
- ClinicalTrials.gov ID
- NCT06094062
- Acronym / sponsor ID
- PIPPI / 2022-00588
- Keywords
- Medication Adherence, Short-term Therapy, Proton Pump Inhibitors, Mobile Health, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: App-based treatment support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based treatment supportThe 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. | Other | Intervention Group |
Primary outcome
Patients with PPI treatment over 30 days
Time frame: 30 days (treatment duration)
Number of patients who started and stopped a PPI after 30 days
4 secondary outcomes
Treatment extensions
Time frame: 30 days (treatment duration)
Physicians' and pharmacists' satisfaction with the service
Time frame: 2 weeks after study completion
Patients' satisfaction with the service
Time frame: 2 weeks after the end of treatment
Reliable diagnosis after PPI treatment
Time frame: After 30 days (treatment duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Arnet, Dr. PD principal investigator
University of Basel, Pharmaceutical Care Research Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based treatment support in people with Heartburn and Dyspepsia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with PPI treatment over 30 days (time frame: 30 days (treatment duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.