Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT06191835
Eligibility Criteria:
Phase A: contextual analysis
Inclusion Criteria:
* Community pharmacists and technicians of 5 participating pharmacies in the French-speaking part of Switzerland and 5 in the German-speaking part of Switzerland
* Primary care physicians working in collaboration or in the neighbourhood of the participating pharmacies
* Patients with long-term treatments, who are a regular patients of the included pharmacies
* International research groups who have implemented NMS within their countries or similar interventions.
Exclusion Criteria:
* Patients not willing to participate
* Patients that do not speak French or German
Phase B: hybrid type 2 effectiveness-implementation study
Patients are eligible for the myCare Start-I phase B study if :
* They are taking part in the myCare Start service
* They have been newly prescribed one or more new long-term medications in accordance with one of the five defined long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD))
* They are 18 years or older
* They have mandatory basic health insurance in Switzerland
* They are 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).
* They understand language spoken by pharmacy staff and are able to read and understand study documents (ge, fr)
* They are able to understand and willing to consent to the myCare Start study (including the agreement on self-reported questionnaires and collection of health care data via their health insurance company)
Exclusion criteria:
• 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).
myCare Start definition of a new medication:
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.
Operational definition of a new medication:
* Active ingredient is indicated for one of the five long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD)).
* Patient has never had this active ingredient dispensed before or restarts an active ingredient after a period of interruption of at least 12 months.
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 on inhalators for asthma/COPD)
* Intensification of dosage regimen (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 1000mg 1-0-0 instead of 500mg 1-0-1; change in antihypertensive drug regimen in elderly patients having vertigo in the morning: 0-0-X instead of X-0-0)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06191835
Study Brief:
Protocol Section:
NCT06191835