Cardio-vascular DiseasemyCare Start-INCT07036471
Supporting Patients Starting New Medicines: Evaluating the myCare Start Service in Switzerland
A study testing myCare Start in people with Cardio-vascular Disease and Depression Disorders, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardio-vascular Disease, Depression Disorders, Diabetes
- What is being tested?
- myCare Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Show all 20Show fewer
- 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.
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Université de Genève
Geneva, Canton of Geneva, 1211
Marie Paule Schneider, Prof. PhD, +41 22 379 53 16, marie.schneider@unige.ch
About this study
Official title: Evaluation of the myCare Start Service to Support Patients Starting a New Medicine in Switzerland: A Hybrid Type II Effectiveness-implementation Study
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.
Read the detailed description
In Switzerland, almost half of the population has a long-term condition. Non-adherence to essential medication to treat these long-term conditions leads to suboptimal patient outcomes, increased hospitalisations, mortality, and financial burden to patients and healthcare systems. Innovative ways to address patient adherence within the ambulatory primary care medicine and community pharmacy setting in Switzerland are needed. Based on the UK New Medicine Service (NMS), pharmaSuisse introduced myCare Start into community pharmacy practice in Switzerland. However, like in other international settings barriers were experienced limiting its uptake and impact highlighting the need for context-based adaptation when the service is implemented in new settings. The myCare Start Implementation project (myCare Start-I) is a biphasic project to assist in optimising fit of the myCare Start service for Switzerland (Phase A) and evaluate its impact (Phase B). In Phase A, which is now complete, using implementation science methods, researchers conducted a thorough contextual analysis of the Swiss primary care ecosystem and adapted the existing myCare Start model using an iterative co-creation process with stakeholders to suit the needs of the primary care context. In Phase B a Type II hybrid effectiveness-implementation study will be conducted to evaluate the effectiveness (improvement in adherence), cost-effectiveness and implementation of the service to build the necessary evidence base to support sustainable funding of the service in the long term.
- Conditions
- Cardio-vascular Disease, Depression Disorders, Diabetes, COPD, Asthma Bronchiale, Hyperlipidaemia
- Being tested
- myCare Start
- Keywords
- patient adherence, medication adherence, medication initiation, long-term treatment, implementation science, interprofessional collaboration, outpatient care, community pharmacy, general practitioner, cost-effectiveness, medication adherence support programme
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Hyperlipidemias, Patient Compliance, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myCare StartBehavioural
The service consists of two 10-minute, semi-structured and tailored consultations delivered by community pharmacists during the first 6 weeks of a patient initiating a new long-term medication, followed by tailored feedback to the patient's physician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | No intervention | In the Usual Care Arm, the patients will receive the usual care from their pharmacist after being prescribed a new long-term medication. |
| myCare Start Arm | Experimental | In the myCare Start Arm, the patients will receive the myCare Start service in their pharmacy after being prescribed a new long-term medication. myCare Start is an interprofessional health service offered by community pharmacies in Switzerland to support medication adherence in patients starting a new long-term treatment. It consists of two 10-minute, semi-structured and tailored consultations delivered by community pharmacists during the first 6 weeks of a patient initiating a new long-term medication, followed by tailored feedback to the patient's physician. Receives: Behavioral: myCare Start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence (subjective measure)
Patient self-reported (subjective measure): We will use the BAASIS© (Basel Assessment of Adherence to Immunosuppressive Medications Scale), a 6-item scale with demonstrated psychometric properties in transplantation and other chronic diseases, as it assesses adherence according to the ABC taxonomy (Initiation, Medication Implementation, and Persistence). The BAASIS scale has a minimum and maximum value of 6 and 30, respectively. Lower scores on the BAASIS indicate poorer adherence to immunosuppressive medications, while higher scores indicate better adherence. This self-report instrument consists of six items that assess different aspects of medication adherence, including dose taking, drug holidays, timing deviation, reduction of dose, persistence, and timing of dose taking.
Measured: Surveys at 14 days, 6 weeks, 3, 6 and12 months upon enrollement.
Secondary outcomes (9)
Medication adherence (objective measure)
Prescription renewal records (objective measure): Medication renewal records will be extracted from health insurance data and analyzed using the "AdhereR" software in R.
Measured: Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study.
Cost-effectiveness short-term
Total healthcare utilisation, in terms of total costs per patient, will be evaluated over the duration of the myCare Start follow-up period (12 months) using health insurance data. This will be combined with adherence results to determine the incremental cost-effectiveness ratio between the total costs per patient in the intervention vs. the control groups and the difference in adherence between groups. The survey will be forwarded to the patient at 14 days, 6 months, and 12 months after inclusion into the study via an emailed online survey. The main analysis consists of calculating 1) the incremental cost-effectiveness ratio between the total costs per patient in the intervention vs. the control group and 2.) the difference in adherence between groups and the probability that the intervention is cost-effective when the willingness to pay varies (i.e. the cost-effectiveness acceptability curve), the two classic indicators of cost-effectiveness analyses of health programmes.
Measured: 12 months upon enrollment
Cost-effectiveness long-term
Long-term potential healthcare cost savings will be evaluated using Markov Modelling. The Markov Modelling approach applied in this study is an adapted version of the models previously used in the UK to evaluate the New Medicine Service, adjusted with parameters tailored to the Swiss context. This approach will enable the projection and estimation of medium- and long-term benefits arising from improved adherence to the prescriptions as a result of the myCare start intervention. In Switzerland, the most commonly prescribed medications for long-term illnesses include cholesterol-lowering therapies, type 2 diabetes drugs, hypertension treatments, and antidepressants. For these four medication groups, specific Markov models have been developed. These calculations will be conducted during the 12-month longitudinal follow-up phase.
Measured: Calculations will be conducted during the 12-month follow-up phase
Implementation Outcome: Acceptability
The AIM (=Acceptability of Intervention Measure) will be used.
Measured: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.
Implementation Outcome: Appropriateness
The IAM (=Intervention Appropriateness Measure) will be used.
Measured: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.
Implementation Outcome: Feasibility
The FIM (=Feasibility of Intervention Measure) will be used.
Measured: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.
Implementation Outcomes: Implementation cost
Cost of implementation will be assessed using the time-driven activity-based cost (TDABC) instrument. This pragmatic method allows investigators to systematically estimate the cost of implementation strategies (e.g. training, reorganisation of practice, regular stakeholder meetings) and the cost of the intervention.
Measured: Throughout the duration of the study - approximately 12 months
Implementation Outcomes: Adoption
Adoption is defined as "the intention, initial decision, or action to try or employ an innovation or evidence-based practice".
It will be measured through investigator onboarding logs and consultation records (No. of invited pharmacies and physicians, No. who completed training, No. who recruited or referred patients, No. of patients who participated in the intervention).
Measured: Throughout the duration of the study - approximately 12 months
Implementation Outcomes: Fidelity
Fidelity is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol.
Consultation records (from the myCare Start consultations) and facilitation checklists will be used, to understand if the service is being carried out as intended and in appropriate areas.
Measured: During the intervention phase of the pharmacies - approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-vascular DiseaseStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Randomised stepped wedge cluster design study
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, pharmaSuisse, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
- Responsible party
- Principal investigator, Marie Paule Schneider, PhD, University of Geneva, Switzerland
- Investigators
- Marie Paule Schneider, Prof. PhD, Principal investigator, Uinversity of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036471
- Sponsor's protocol ID
- 2025-00715
- Other IDs
- 2025
- Acronym
- myCare Start-I
- Status last verified
- Apr 2025
- First submitted
- 12 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once fully anonymized, quantitative data will be annotated and structured to make them sharable, and registered in a FAIR-compliant data repository.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the myCare Start Service to Support Patients Starting a New Medicine in Switzerland: A Hybrid Type II Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT07036471
- Acronym / sponsor ID
- myCare Start-I / 2025-00715
- Conditions
- Cardio-vascular Disease, Depression Disorders, Diabetes, COPD, Asthma Bronchiale, Hyperlipidaemia
- Keywords
- patient adherence, medication adherence, medication initiation, long-term treatment, implementation science, interprofessional collaboration, outpatient care, community pharmacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, pharmaSuisse, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
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.
Detailed description
In Switzerland, almost half of the population has a long-term condition. Non-adherence to essential medication to treat these long-term conditions leads to suboptimal patient outcomes, increased hospitalisations, mortality, and financial burden to patients and healthcare systems. Innovative ways to address patient adherence within the ambulatory primary care medicine and community pharmacy setting in Switzerland are needed. Based on the UK New Medicine Service (NMS), pharmaSuisse introduced myCare Start into community pharmacy practice in Switzerland. However, like in other international settings barriers were experienced limiting its uptake and impact highlighting the need for context-based adaptation when the service is implemented in new settings. The myCare Start Implementation project (myCare Start-I) is a biphasic project to assist in optimising fit of the myCare Start service for Switzerland (Phase A) and evaluate its impact (Phase B). In Phase A, which is now complete, using implementation science methods, researchers conducted a thorough contextual analysis of the Swiss primary care ecosystem and adapted the existing myCare Start model using an iterative co-creation process with stakeholders to suit the needs of the primary care context. In Phase B a Type II hybrid effectiveness-implementation study will be conducted to evaluate the effectiveness (improvement in adherence), cost-effectiveness and implementation of the service to build the necessary evidence base to support sustainable funding of the service in the long term.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised stepped wedge cluster design study
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | No intervention | –In the Usual Care Arm, the patients will receive the usual care from their pharmacist after being prescribed a new long-term medication. |
| myCare Start Arm | Experimental | Behavioral: myCare StartIn the myCare Start Arm, the patients will receive the myCare Start service in their pharmacy after being prescribed a new long-term medication. myCare Start is an interprofessional health service offered by community pharmacies in Switzerland to support medication adherence in patients starting a new long-term treatment. It consists of two 10-minute, semi-structured and tailored consultations delivered by community pharmacists during the first 6 weeks of a patient initiating a new long-term medication, followed by tailored feedback to the patient's physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| myCare StartThe service consists of two 10-minute, semi-structured and tailored consultations delivered by community pharmacists during the first 6 weeks of a patient initiating a new long-term medication, followed by tailored feedback to the patient's physician. | Behavioural | myCare Start Arm |
Primary outcome
Medication adherence (subjective measure)
Time frame: Surveys at 14 days, 6 weeks, 3, 6 and12 months upon enrollement.
Patient self-reported (subjective measure): We will use the BAASIS© (Basel Assessment of Adherence to Immunosuppressive Medications Scale), a 6-item scale with demonstrated psychometric properties in transplantation and other chronic diseases, as it assesses adherence according to the ABC taxonomy (Initiation, Medication Implementation, and Persistence). The BAASIS scale has a minimum and maximum value of 6 and 30, respectively. Lower scores on the BAASIS indicate poorer adherence to immunosuppressive medications, while higher scores indicate better adherence. This self-report instrument consists of six items that assess different aspects of medication adherence, including dose taking, drug holidays, timing deviation, reduction of dose, persistence, and timing of dose taking.
9 secondary outcomes
Medication adherence (objective measure)
Time frame: Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study.
Cost-effectiveness short-term
Time frame: 12 months upon enrollment
Cost-effectiveness long-term
Time frame: Calculations will be conducted during the 12-month follow-up phase
Implementation Outcome: Acceptability
Time frame: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.
Implementation Outcome: Appropriateness
Time frame: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.
Implementation Outcome: Feasibility
Time frame: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.
Implementation Outcomes: Implementation cost
Time frame: Throughout the duration of the study - approximately 12 months
Implementation Outcomes: Adoption
Time frame: Throughout the duration of the study - approximately 12 months
Implementation Outcomes: Fidelity
Time frame: During the intervention phase of the pharmacies - approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided. Once fully anonymized, quantitative data will be annotated and structured to make them sharable, and registered in a FAIR-compliant data repository.
Related trials for Cardio-vascular Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study
Systemic Lupus Erythematosus, Atherosclerosis Generalized
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
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.
Marie Paule Schneider, Prof. PhD principal investigator
Uinversity of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myCare Start in people with Cardio-vascular Disease and Depression Disorders, run by University of Geneva, Switzerland at 1 site 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 20 inclusion and 2 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: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule Schneider, Prof. PhD (+41 22 379 53 16, marie.schneider@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (subjective measure) (time frame: Surveys at 14 days, 6 weeks, 3, 6 and12 months upon enrollement.). 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 25 Jun 2025.