Infection, BacterialSMAPPNCT06126900
Smartphone App-assisted Short-term Antibiotic Therapy
A study testing Smartphone medication intake reminder + educational and motivational text messaging in people with Infection, Bacterial, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
Outpatients with short-term antibiotic treatment should start and finish the treatment according to medical advise that is, the intake pattern (named adherence) should be regular. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Smartphone medication intake reminder + educational and motivational text messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 15 Jan 2024to 31 Dec 2024
- 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 min. 18 years old;
- is newly prescribed a co-amoxicillin treatment of 3-14 days;
- has symptoms that correspond to bacterial infection;
- accepts to use of one of the medication adherence application with reminder function from the provided list;
- accepts to use of the electronic monitoring application TOM™ during the study period;
- is capable of using the TOM™ application;
- signs the informed consent form;
- understands and speaks (Swiss) German.
Who cannot join
- in the opinion of the pharmacists, unlikely to comply with the study schedule or are unsuitable for any other reason.
- does not manage medication himself/herself
- already using a medication intake reminder
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Greifen Apotheke
Basel, Canton of Basel-City, 4058
TopPharm Hirschen Apotheke
Magden, Canton of Aargau, 4312
About this study
Official title: Smartphone App-assisted Short-term Antibiotic Therapy - a Cluster-randomized Study in Primary Care
Outpatients with short-term antibiotic treatment should start and finish the treatment according to medical advise that is, the intake pattern (named adherence) should be regular. The research question is: Can a smartphone-based program including intake reminder and two text messages improve adherence to a short-term antibiotic treatment in ambulatory setting?
Participants will be asked to record every antibiotic intake in an app on their smartphone over the prescribed therapy duration and to note their symptoms once daily. One group will obtain reminder + text messages, and the control group will have no reminder + no text messages.
Read the detailed description
This study is planned as a monocentric, cluster-randomized, double-blind, two-arm study in a primary care setting with outpatients newly prescribed co-amoxicillin for a short-term therapy. Participating community pharmacies will recruit patients entering with a prescription for co-amoxicillin and offer the service. Randomisation will take place on the pharmacy level via computer generated list of numbers (1: with intervention; 2: with no intervention). Pharmacists and participants will not know that the intervention is not the app itself, but rather the combination of a reminder and text messages (= double-blind). The intervention will consist of the use of a smartphone reminder (e.g. alarm clock or a reminder app; a list with suitable examples will be given and patients will choose one of them) and two personalized motivational and educational text messages that will be sent by the pharmacy during the treatment duration. The control group will have no reminder and no text messages. All participants will use a simplified version of the freely available medication management app TOM to record their medication intake (= adherence measurement method). Participants in both groups will obtain a consultation driven by their adherence report with the study team at the end of the treatment to discuss their individual adherence data, their symptom course and well-being. After that, patients will receive a link to an online survey where they will evaluate their satisfaction with the service and the smartphone application. Participating pharmacists will be interviewed by the study team regarding their experience and satisfaction after the end of the study.
- Conditions
- Infection, Bacterial
- Being tested
- Smartphone medication intake reminder + educational and motivational text messaging
- Keywords
- Medication Adherence, Short-term therapy, Anti-Bacterial Agents, Mobile Health
- Medical subject headings
- Bacterial Infections, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone medication intake reminder + educational and motivational text messagingOther
The intervention includes the use of a smartphone-based medication intake reminder, along with two educational and motivational text messages during the therapy period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Reminder + text messaging Receives: Other: Smartphone medication intake reminder + educational and motivational text messaging |
| Control Group | No intervention | No reminder + no text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates (in percent)
Patients confirm every medication intakes in the app. The app will deliver time stamps. Based on these, taking, dosing and timing adherence will be calculated in percent.
Measured: Up to 14 days (maximum therapy duration)
Secondary outcomes (4)
Persistence rate (in percent)
Patients confirm every medication intakes in the app. The app will deliver time stamps. Based on these, persistence rate to the therapy will be calculated: [days with at least one dose / prescribed treatment days] × 100
Measured: Up to 14 days (maximum therapy duration)
Time to symptom control
Patients will note in a diary their symptoms once daily. Time to symptom control will be calculated as number of days up to freedom of symptoms.
Measured: Up to 14 days (maximum therapy duration)
Pharmacists' satisfaction with the service including the app
Satisfaction will be assessed through semi-structured interviews and analyzed inductively.
Measured: 2 weeks after study completion
Patients' satisfaction with the service including the app
Satisfaction will be assessed quantitatively in an online-survey on a 5-point Likert-scale. High values will indicate a better outcome.
Measured: 7 days after therapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 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
- NCT06126900
- Sponsor's protocol ID
- 2023-01753
- Other IDs
- 2023
- Acronym
- SMAPP
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App-assisted Short-term Antibiotic Therapy - a Cluster-randomized Study in Primary Care
- ClinicalTrials.gov ID
- NCT06126900
- Acronym / sponsor ID
- SMAPP / 2023-01753
- Conditions
- Infection, Bacterial
- Keywords
- Medication Adherence, Short-term therapy, Anti-Bacterial Agents, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Nov 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.
Outpatients with short-term antibiotic treatment should start and finish the treatment according to medical advise that is, the intake pattern (named adherence) should be regular. The research question is: Can a smartphone-based program including intake reminder and two text messages improve adherence to a short-term antibiotic treatment in ambulatory setting?
Participants will be asked to record every antibiotic intake in an app on their smartphone over the prescribed therapy duration and to note their symptoms once daily. One group will obtain reminder + text messages, and the control group will have no reminder + no text messages.
Detailed description
This study is planned as a monocentric, cluster-randomized, double-blind, two-arm study in a primary care setting with outpatients newly prescribed co-amoxicillin for a short-term therapy. Participating community pharmacies will recruit patients entering with a prescription for co-amoxicillin and offer the service. Randomisation will take place on the pharmacy level via computer generated list of numbers (1: with intervention; 2: with no intervention). Pharmacists and participants will not know that the intervention is not the app itself, but rather the combination of a reminder and text messages (= double-blind). The intervention will consist of the use of a smartphone reminder (e.g. alarm clock or a reminder app; a list with suitable examples will be given and patients will choose one of them) and two personalized motivational and educational text messages that will be sent by the pharmacy during the treatment duration. The control group will have no reminder and no text messages. All participants will use a simplified version of the freely available medication management app TOM to record their medication intake (= adherence measurement method). Participants in both groups will obtain a consultation driven by their adherence report with the study team at the end of the treatment to discuss their individual adherence data, their symptom course and well-being. After that, patients will receive a link to an online survey where they will evaluate their satisfaction with the service and the smartphone application. Participating pharmacists will be interviewed by the study team regarding their experience and satisfaction after the end of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Smartphone medication intake reminder + educational and motivational text messagingReminder + text messaging |
| Control Group | No intervention | –No reminder + no text messaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- is min. 18 years old;
- is newly prescribed a co-amoxicillin treatment of 3-14 days;
- has symptoms that correspond to bacterial infection;
- accepts to use of one of the medication adherence application with reminder function from the provided list;
- accepts to use of the electronic monitoring application TOM™ during the study period;
Key exclusion criteria (3 listed)
- in the opinion of the pharmacists, unlikely to comply with the study schedule or are unsuitable for any other reason.
- does not manage medication himself/herself
- already using a medication intake reminder
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 |
|---|---|---|
| Smartphone medication intake reminder + educational and motivational text messagingThe intervention includes the use of a smartphone-based medication intake reminder, along with two educational and motivational text messages during the therapy period. | Other | Intervention Group |
Primary outcome
Adherence rates (in percent)
Time frame: Up to 14 days (maximum therapy duration)
Patients confirm every medication intakes in the app. The app will deliver time stamps. Based on these, taking, dosing and timing adherence will be calculated in percent.
4 secondary outcomes
Persistence rate (in percent)
Time frame: Up to 14 days (maximum therapy duration)
Time to symptom control
Time frame: Up to 14 days (maximum therapy duration)
Pharmacists' satisfaction with the service including the app
Time frame: 2 weeks after study completion
Patients' satisfaction with the service including the app
Time frame: 7 days after therapy completion
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 9 Jan 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 Smartphone medication intake reminder + educational and motivational text messaging in people with Infection, Bacterial, 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 8 inclusion and 3 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 9 Jan 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?
Adherence rates (in percent) (time frame: Up to 14 days (maximum therapy 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 9 Jan 2025.