Medication Initiation for Long-term ConditionsmyCareStart-INCT06191835
Implementation of a New Model of Care for Supporting Long-term Medication Adherence (Phase A)
An observational study of Medication Initiation for Long-term Conditions, run by University of Geneva, Switzerland at 2 sites in Switzerland.
Trial summary
The overall objective of the myCare Start-I project is to adapt, implement and evaluate the myCare Start service within the Swiss pharmacy-physician network to enhance medication adherence during the initiation of a new long-term treatment. The study will use an implementation science approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Initiation for Long-term Conditions
- What is being tested?
- myCare Start
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 30 Aug 2023to 30 Jun 2026
- Phase
- Observational
- 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
Study population: Phase A: contextual analysis Community pharmacists and technicians General practitioners or internal medicine physicians Patients with a long-term treatment International research groups Phase B: effectiveness-implementation study Patients with a long-term treatment for five long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD))
Who may be able to join
- 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.
Who cannot join
- 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))
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- 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)
- 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)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University of Basel
Basel, 4056
Université de Genève
Geneva, Canton of Geneva, 1211
About this study
Official title: Implementation of a New Model of Care for Supporting Adherence in People Starting a New Medication for a Long-term Condition (myCare Start-I Project) - An Implementation Science Study - Phase A
The overall objective of the myCare Start-I project is to adapt, implement and evaluate the myCare Start service within the Swiss pharmacy-physician network to enhance medication adherence during the initiation of a new long-term treatment. The study will use an implementation science approach. The myCare Start service is based on the New Medicine Service (NMS) that was developed in the United Kingdom.
Read the detailed description
Phase A:
- To conduct a contextual analysis of the current Swiss primary care ecosystem as related to pharmacy-physician interprofessional health services for patients with long-term diseases (i.e., contextual analysis).
- To engage key stakeholders within the Swiss primary care ecosystem to contribute to the co-creation of a Swiss interprofessional myCare Start service (i.e., stakeholder involvement).
- To design a contextually adapted myCare Start for use within Swiss community practice using contextually appropriate implementation strategies (i.e., intervention development/selecting implementation strategies).
- To conduct feasibility testing on the contextually adapted intervention and implementation strategies and to develop an implementation research logic model (i.e., feasibility testing). Phase B: Please note Phase B will be carried out at a later date with further ethics committee approval.
- To implement a contextually adapted Swiss myCare Start intervention in the pharmacy-physician network community and evaluate it in terms of medication adherence and cost-effectiveness outcomes.
- To evaluate implementation outcomes and the implementation pathway of myCare Start.
- Being tested
- myCare Start
- Keywords
- 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
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myCare StartBehavioural
Also called New Medicine Service
The service consists of 2 times 10-minutes semi-structured pharmaceutical interventions between community pharmacist and patient, tailored to the patient's needs, positioned as partner, during the first 6 weeks after treatment initiation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence (objective measure)
Prescription renewal records (objective measure):
Medication renewal records will be extracted from pharmaceutical records and analyzed using the "AdhereR" software in R.
Measured: 6 - 12 months
Medication adherence (subjective measure)
Patient self-assessment (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: 6 - 12 months
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
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: 12 months
Implementations Outcomes
The myCare start service will be evaluated in terms of acceptability, adoption, appropriateness, fidelity, feasibility, and implementation cost as proposed by Proctor's Implementation Outcomes Taxonomy (Proctor et al., 2019).
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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start30 Aug 2023
- Primary completion16 Jan 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication Initiation for Long-term ConditionsStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Fundació Sant Joan de Déu, pharmaSuisse, Switzerland, 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, PhD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191835
- Sponsor's protocol ID
- 2023-01161
- Other IDs
- 2023
- Acronym
- myCareStart-I
- Status last verified
- Apr 2025
- First submitted
- 13 Oct 2023
- Last updated
- 18 Apr 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.
Publications
Serhal S, Mielke J, Shamuratova K, Boisier T, Allemann S, Barbati S, Walti LS, Haller DM, Pfarrwaller E, Lanier C, Mulder F, Kalumiya KM, Maes KA, Dupuis M, Jenkinson SP, Panchaud A, Dima AL, De Geest S, Schneider MP. Context analysis as a foundational step to inform the design and implementation of an interprofessional primary care model for new long-term medication users - the myCare Start Implementation Science Project. Res Social Adm Pharm. 2026 Jul 24:S1551-7411(26)00167-1. doi: 10.1016/j.sapharm.2026.07.007. Online ahead of print.
PubMed 42542414
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a New Model of Care for Supporting Adherence in People Starting a New Medication for a Long-term Condition (myCare Start-I Project) - An Implementation Science Study - Phase A
- ClinicalTrials.gov ID
- NCT06191835
- Acronym / sponsor ID
- myCareStart-I / 2023-01161
- Keywords
- medication adherence, medication initiation, long-term treatment, implementation science, interprofessional collaboration, outpatient care, community pharmacy, General practitioner
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Fundació Sant Joan de Déu, pharmaSuisse, Switzerland, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
The overall objective of the myCare Start-I project is to adapt, implement and evaluate the myCare Start service within the Swiss pharmacy-physician network to enhance medication adherence during the initiation of a new long-term treatment. The study will use an implementation science approach. The myCare Start service is based on the New Medicine Service (NMS) that was developed in the United Kingdom.
Detailed description
Phase A:
- To conduct a contextual analysis of the current Swiss primary care ecosystem as related to pharmacy-physician interprofessional health services for patients with long-term diseases (i.e., contextual analysis).
- To engage key stakeholders within the Swiss primary care ecosystem to contribute to the co-creation of a Swiss interprofessional myCare Start service (i.e., stakeholder involvement).
- To design a contextually adapted myCare Start for use within Swiss community practice using contextually appropriate implementation strategies (i.e., intervention development/selecting implementation strategies).
- To conduct feasibility testing on the contextually adapted intervention and implementation strategies and to develop an implementation research logic model (i.e., feasibility testing). Phase B: Please note Phase B will be carried out at a later date with further ethics committee approval.
- To implement a contextually adapted Swiss myCare Start intervention in the pharmacy-physician network community and evaluate it in terms of medication adherence and cost-effectiveness outcomes.
- To evaluate implementation outcomes and the implementation pathway of myCare Start.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phase A: contextual analysis Community pharmacists and technicians General practitioners or internal medicine physicians Patients with a long-term treatment International research groups Phase B: effectiveness-implementation study Patients with a long-term treatment for five long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD))
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- Patients not willing to participate
- Patients that do not speak French or German
- Phase B: hybrid type 2 effectiveness-implementation study
- 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))
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 StartAlso: New Medicine ServiceThe service consists of 2 times 10-minutes semi-structured pharmaceutical interventions between community pharmacist and patient, tailored to the patient's needs, positioned as partner, during the first 6 weeks after treatment initiation. | Behavioural | – |
Primary outcome
Medication adherence (objective measure)
Time frame: 6 - 12 months
Prescription renewal records (objective measure): Medication renewal records will be extracted from pharmaceutical records and analyzed using the "AdhereR" software in R.
Medication adherence (subjective measure)
Time frame: 6 - 12 months
Patient self-assessment (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.
Cost-effectiveness short-term
Time frame: 12 months
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.
Cost-effectiveness long-term
Time frame: 12 months
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.
Implementations Outcomes
Time frame: 12 months
The myCare start service will be evaluated in terms of acceptability, adoption, appropriateness, fidelity, feasibility, and implementation cost as proposed by Proctor's Implementation Outcomes Taxonomy (Proctor et al., 2019). 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.
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 18 Apr 2025.
- Derived from this study: PubMed 42542414Serhal S, Mielke J, Shamuratova K, Boisier T, Allemann S, Barbati S, Walti LS, Haller DM, Pfarrwaller E, Lanier C, Mulder F, Kalumiya KM, Maes KA, Dupuis M, Jenkinson SP, Panchaud A, Dima AL, De Geest S, Schneider MP. Context analysis as a foundational step to inform the design and implementation of an interprofessional primary care model for new long-term medication users - the myCare Start Implementation Science Project. Res Social Adm Pharm. 2026 Jul 24:S1551-7411(26)00167-1. doi: 10.1016/j.sapharm.2026.07.007. Online ahead of print.
- 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 Medication Initiation for Long-term Conditions
Not yet recruiting
Supporting Patients Starting New Medicines: Evaluating the myCare Start Service in Switzerland
Cardio-vascular Disease, Depression Disorders
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.
Marie Paule Schneider, PhD principal investigator
University of Geneva, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Initiation for Long-term Conditions, run by University of Geneva, 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 4 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 18 Apr 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?
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?
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?
Medication adherence (objective measure) (time frame: 6 - 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06191835, which also lists 1 linked publication.
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 18 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.