NCT07036471Not yet recruiting
Supporting Patients Starting New Medicines: Evaluating the myCare Start Service in Switzerland
Evaluation of the myCare Start Service to Support Patients Starting a New Medicine in Switzerland: A Hybrid Type II Effectiveness-implementation Study
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In Phase B, the aim is to evaluate the myCare Start service in routine care within the ambulatory primary care medicine and community pharmacy setting in Switzerland. A Type II hybrid effectiveness-implementation study will be conducted to evaluate the effectiveness (improvement in adherence), cost-effectiveness and implementation of the service. This evaluation will allow us to build the necessary contextual relevant evidence base to support sustainable funding of the service in the long term.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1600 (estimated)
- First submitted
- 12 May 2025
- Start date
- Jun 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- University of Geneva, Switzerland
- Diseases
- Asthma, COPD, Type 2 diabetes
- NCT number
- NCT07036471
What you commit to
- Study type: Interventional
- Planned participants: 1600
- From Jun 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients participating or having participated in an education program about their disease or treatment in the last 3 months, led by healthcare providers such as physicians, nurses, pharmacists or other (e.g. education provided by nurses for type I diabetes patients)
- Physicians:
Who the study is looking for
- Must have mandatory basic health insurance in Switzerland
- Must have been newly prescribed one or more new long-term medications in accordance with the following chronic conditions: cadisovascular diseases (incl. hyertension and thromboprophylaxis), diabetes, hyperlipidemia, depression, respiratory illness (asthma and COPD)
- Must be able to self-manage treatment (i.e. they live at home without any support to manage their medication, exception: patient uses a pill dispenser and fills it in by him-/herself)
- Must be able to understand language spoken by pharmacy staff and can read and understand study documents (French, German, English)
- Must understand and are willing to consent to the myCare Start-I study (including the agreement on self-reported questionnaires and collection of health care data via their health insurance company)
- in the intervention arm, patients must receive the myCare Start service
- For this study, a new medication is a medication that has not been previously dispensed to the patient. This includes one or more new medications for a new diagnosis and or new medications for pre-existing diagnosis of a long-term condition. Included in this working definition:
- The new medication is indicated for one of the five long-term diseases listed above
- Patient has never had this active ingredient dispensed before (patient still considered eligible if they have received a small initial sample pack from their physician) or restarts an active ingredient after a period of interruption of at least 12 months (time period to be reported by the patient). Please note that for patients, that have already started a sample pack of medication the myCare Start Consultation One can start upon first dispensation at the pharmacy, there is no need to wait 7-14 days.
- The new active ingredient can be part of a combo preparation (e.g. a diuretic added to an ACE inhibitor into the same preparation)
- Patient has had no change in active ingredient but has an important change in treatment administration, such as:
- Change of galenic form (e.g. two different types of inhalators for asthma/COPD)
- Intensification of dosage regiment (e.g. twice a day instead of once a day)
- The following change is not considered as medication initiation:
- New dosage of already known active ingredient (e.g. dose escalation of antidepressants)
- Simplification of administration mode (e.g. metformin 1000 mg 1-0-0 instead of 500 mg 1-0-1; change in antihypertensive drug regiment in elderly patients having vertigo in the morning: 0-0-X instead of X-0-0)
- \- Any physician treating a patient for one of the five long-term illnesses listed above is eligible to refer the patient to a pharmacy providing myCare start.
- Pharmacies:
- Have to be enrolled into the myCare Start service and comply to the requirements of the pharmacy quality system management of having access to a private consultation room or area
- Must agree to participate in the research study, including the recruitment of control patients and the delivery of the myCare Start service to intervention patients.
Criteria the registry did not label
- Patients
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Université de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.