DepressionSIMCANCT02187380
Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants
An observational study of Depression and Antidepressant, run by KU Leuven at 1 site in Belgium.
Trial summary
The objective of the SIMCA study was to analyse the impact of structured medication counselling by community pharmacists on medication adherence, economic, clinical and humanistic outcomes of depressed primary care patients who started a new treatment with antidepressants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Antidepressant
- How many people
- 223 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Aug 2012
- Phase
- Observational
- 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
Study population: primary care patients with a new prescription for antidepressants in Flanders, Belgium.
Who may be able to join
- at least 18 years old
- able to understand and complete Dutch questionnaires
- could be reached by telephone for follow-up
Who cannot join
- used antidepressants over the last six months
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the SIMCA study was to analyse the impact of structured medication counselling by community pharmacists on medication adherence, economic, clinical and humanistic outcomes of depressed primary care patients who started a new treatment with antidepressants.
A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At the time of the start of the study, the Surplus Network included 97 pharmacies, in all five Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were informed about the SIMCA-study and instructed how to approach eligible patients.
Read more
Randomisation was obtained at the pharmacy level by a computerized random-number generator, following a permuted block design (1:1). The Surplus Network contains a number of local pharmacy chains; stratification was used to ensure equal distribution within local pharmacy chains.
Pharmacists in the intervention group were trained in communication skills related to depression treatment counselling in groups of no more than 10 participants over a single day. In total, 10 training days were scheduled between November and December, 2010.
Patients were eligible for inclusion in the study if they started using at least one antidepressant drug, if they were at least 18 years old, if they were able to understand and complete Dutch questionnaires and if they could be reached by telephone for follow-up. "Starting" was defined as not having been prescribed antidepressants over the last six months, which was checked in the pharmacy records. If the patient gave verbal consent to the pharmacist, to be contacted by the research team, the patient was provided with written and oral information about the SIMCA project and a consent form. At the same time an automatic e-mail was generated from the pharmacy software to inform the research team about the patient's willingness to be contacted about the study. The patient was contacted by the research team, as soon as possible to give more information about the study, to ask for informed consent and to schedule a first telephone survey interview. If the patient wished to participate, he/she completed the consent form, and sent it back with the included postage-paid envelope addressed to the research team. Upon receipt of the consent form, the recruited patient's prescribing doctor was contacted and asked to complete and return a brief questionnaire to provide the diagnosis and its severity related to prescribing antidepressants.
Telephone survey interviews based on validated scales were used to collect data at the start of treatment (as close as possible to the time of recruitment), after one month, three months and six months of treatment.
- Conditions
- Depression, Antidepressant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Pharmacists received no depression training, delivered usual care to patients starting a new treatment with depression. | |
| Intervention group | Pharmacists received a depression training day and provided structured medication counselling to patients starting a new treatment with antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence measured by the MMAS-8
Measured: 1 month after start of antidepressants treatment
Medication adherence
Medication adherence measured by the MMAS-8
Measured: 3 months after start of antidepressants treatment
Medication adherence
Medication adherence measured by the MMAS-8
Measured: 6 months after start of antidepressants treatment
Secondary outcomes (38)
Economic outcomes
Economic outcomes are measured by the WPAI
Measured: at the start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Measured: 1 month after the start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Measured: 3 months after the start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Measured: 6 months after the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Measured: at the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Measured: 1 month after the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Measured: 3 months after the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Measured: 6 months after the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Measured: At the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Measured: 1 month after the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Measured: 3 months after the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Measured: 6 months after the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Measured: At the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Measured: 1 month after the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Measured: 3 months after the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Measured: 6 months after the start of antidepressants treatment
Feelings about side effects
Patients' feelings about side effects of antidepressants are measured by the FSE
Measured: 1 month after the start of antidepressants treatment
Feelings about side effects
Patients' feelings about side effects of antidepressants are measured by the FSE
Measured: 3 months after the start of antidepressants treatment
Feelings about side effects
Patients' feelings about side effects of antidepressants are measured by the FSE
Measured: 6 months after the start of antidepressants treatment
Satisfaction with treatment
Patients' satisfaction with antidepressants treatment is measured by the SWT
Measured: 1 month after the start of antidepressants treatment
Satisfaction with treatment
Patients' satisfaction with antidepressants treatment is measured by the SWT
Measured: 3 months after the start of antidepressants treatment
Satisfaction with treatment
Patients' satisfaction with antidepressants treatment is measured by the SWT
Measured: 6 months after the start of antidepressants treatment
Satisfaction with information regarding treatment
Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
Measured: At the start of antidepressants treatment
Satisfaction with information regarding treatment
Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
Measured: 1 month after the start of antidepressants treatment
Satisfaction with information regarding treatment
Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
Measured: 3 months after the start of antidepressants treatment
Satisfaction with information regarding treatment
Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
Measured: 6 months after the start of antidepressants treatment
Satisfaction with information regarding side effects
Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
Measured: At the start of antidepressants treatment
Satisfaction with information regarding side effects
Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
Measured: 1 month after the start of antidepressants treatment
Satisfaction with information regarding side effects
Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
Measured: 3 months after the start of antidepressants treatment
Satisfaction with information regarding side effects
Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
Measured: 6 months after the start of antidepressants treatment
Health-related quality of life
Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
Measured: At the start of antidepressants treatment
Health-related quality of life
Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
Measured: 1 month after the start of antidepressants treatment
Health-related quality of life
Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
Measured: 3 months after the start of antidepressants treatment
Health-related quality of life
Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
Measured: 6 months after the start of antidepressants treatment
Enjoyment and satisfaction
Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
Measured: At the start of antidepressants treatment
Enjoyment and satisfaction
Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
Measured: 1 month after the start of antidepressants treatment
Enjoyment and satisfaction
Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
Measured: 3 months after the start of antidepressants treatment
Enjoyment and satisfaction
Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
Measured: 6 months after the start of antidepressants treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2010
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Liekens, KU Leuven
- Investigators
- Sophie Liekens, M Psy, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187380
- Sponsor's protocol ID
- B32220109082
- Other IDs
- s52518
- Acronym
- SIMCA
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants
- ClinicalTrials.gov ID
- NCT02187380
- Acronym / sponsor ID
- SIMCA / B32220109082
- Conditions
- Depression, Antidepressant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2012 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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 objective of the SIMCA study was to analyse the impact of structured medication counselling by community pharmacists on medication adherence, economic, clinical and humanistic outcomes of depressed primary care patients who started a new treatment with antidepressants.
A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At the time of the start of the study, the Surplus Network included 97 pharmacies, in all five Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were informed about the SIMCA-study and instructed how to approach eligible patients.
Randomisation was obtained at the pharmacy level by a computerized random-number generator, following a permuted block design (1:1). The Surplus Network contains a number of local pharmacy chains; stratification was used to ensure equal distribution within local pharmacy chains.
Pharmacists in the intervention group were trained in communication skills related to depression treatment counselling in groups of no more than 10 participants over a single day. In total, 10 training days were scheduled between November and December, 2010.
Patients were eligible for inclusion in the study if they started using at least one antidepressant drug, if they were at least 18 years old, if they were able to understand and complete Dutch questionnaires and if they could be reached by telephone for follow-up. "Starting" was defined as not having been prescribed antidepressants over the last six months, which was checked in the pharmacy records. If the patient gave verbal consent to the pharmacist, to be contacted by the research team, the patient was provided with written and oral information about the SIMCA project and a consent form. At the same time an automatic e-mail was generated from the pharmacy software to inform the research team about the patient's willingness to be contacted about the study. The patient was contacted by the research team, as soon as possible to give more information about the study, to ask for informed consent and to schedule a first telephone survey interview. If the patient wished to participate, he/she completed the consent form, and sent it back with the included postage-paid envelope addressed to the research team. Upon receipt of the consent form, the recruited patient's prescribing doctor was contacted and asked to complete and return a brief questionnaire to provide the diagnosis and its severity related to prescribing antidepressants.
Telephone survey interviews based on validated scales were used to collect data at the start of treatment (as close as possible to the time of recruitment), after one month, three months and six months of treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Pharmacists received no depression training, delivered usual care to patients starting a new treatment with depression. |
| Intervention group | – | –Pharmacists received a depression training day and provided structured medication counselling to patients starting a new treatment with antidepressants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care patients with a new prescription for antidepressants in Flanders, Belgium.
Key inclusion criteria (3 listed)
- at least 18 years old
- able to understand and complete Dutch questionnaires
- could be reached by telephone for follow-up
Key exclusion criteria (1 listed)
- used antidepressants over the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication adherence
Time frame: 1 month after start of antidepressants treatment
Medication adherence measured by the MMAS-8
Medication adherence
Time frame: 3 months after start of antidepressants treatment
Medication adherence measured by the MMAS-8
Medication adherence
Time frame: 6 months after start of antidepressants treatment
Medication adherence measured by the MMAS-8
38 secondary outcomes
Economic outcomes
Time frame: at the start of antidepressants treatment
Economic outcomes
Time frame: 1 month after the start of antidepressants treatment
Economic outcomes
Time frame: 3 months after the start of antidepressants treatment
Economic outcomes
Time frame: 6 months after the start of antidepressants treatment
Clinical outcomes
Time frame: at the start of antidepressants treatment
Clinical outcomes
Time frame: 1 month after the start of antidepressants treatment
Clinical outcomes
Time frame: 3 months after the start of antidepressants treatment
Clinical outcomes
Time frame: 6 months after the start of antidepressants treatment
Beliefs about medicines
Time frame: At the start of antidepressants treatment
Beliefs about medicines
Time frame: 1 month after the start of antidepressants treatment
Beliefs about medicines
Time frame: 3 months after the start of antidepressants treatment
Beliefs about medicines
Time frame: 6 months after the start of antidepressants treatment
Satisfaction with the pharmacist
Time frame: At the start of antidepressants treatment
Satisfaction with the pharmacist
Time frame: 1 month after the start of antidepressants treatment
Satisfaction with the pharmacist
Time frame: 3 months after the start of antidepressants treatment
Satisfaction with the pharmacist
Time frame: 6 months after the start of antidepressants treatment
Feelings about side effects
Time frame: 1 month after the start of antidepressants treatment
Feelings about side effects
Time frame: 3 months after the start of antidepressants treatment
Feelings about side effects
Time frame: 6 months after the start of antidepressants treatment
Satisfaction with treatment
Time frame: 1 month after the start of antidepressants treatment
Satisfaction with treatment
Time frame: 3 months after the start of antidepressants treatment
Satisfaction with treatment
Time frame: 6 months after the start of antidepressants treatment
Satisfaction with information regarding treatment
Time frame: At the start of antidepressants treatment
Satisfaction with information regarding treatment
Time frame: 1 month after the start of antidepressants treatment
Satisfaction with information regarding treatment
Time frame: 3 months after the start of antidepressants treatment
Satisfaction with information regarding treatment
Time frame: 6 months after the start of antidepressants treatment
Satisfaction with information regarding side effects
Time frame: At the start of antidepressants treatment
Satisfaction with information regarding side effects
Time frame: 1 month after the start of antidepressants treatment
Satisfaction with information regarding side effects
Time frame: 3 months after the start of antidepressants treatment
Satisfaction with information regarding side effects
Time frame: 6 months after the start of antidepressants treatment
Health-related quality of life
Time frame: At the start of antidepressants treatment
Health-related quality of life
Time frame: 1 month after the start of antidepressants treatment
Health-related quality of life
Time frame: 3 months after the start of antidepressants treatment
Health-related quality of life
Time frame: 6 months after the start of antidepressants treatment
Enjoyment and satisfaction
Time frame: At the start of antidepressants treatment
Enjoyment and satisfaction
Time frame: 1 month after the start of antidepressants treatment
Enjoyment and satisfaction
Time frame: 3 months after the start of antidepressants treatment
Enjoyment and satisfaction
Time frame: 6 months after the start of antidepressants treatment
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 11 Jul 2014.
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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.
Sophie Liekens, M Psy principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Antidepressant, run by KU Leuven at 1 site in Belgium.
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 3 inclusion and 1 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 11 Jul 2014. 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 Belgium. 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?
Medication adherence (time frame: 1 month after start of antidepressants treatment). The study lists 3 primary outcomes in all. 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 11 Jul 2014.