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 Type
OBSERVATIONAL
Enrollment
223
KU Leuven
Leuven, Vlaams Brabant, Belgium
Medication adherence
Medication adherence measured by the MMAS-8
Time frame: 1 month after start of antidepressants treatment
Medication adherence
Medication adherence measured by the MMAS-8
Time frame: 3 months after start of antidepressants treatment
Medication adherence
Medication adherence measured by the MMAS-8
Time frame: 6 months after start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Time frame: at the start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Time frame: 1 month after the start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Time frame: 3 months after the start of antidepressants treatment
Economic outcomes
Economic outcomes are measured by the WPAI
Time frame: 6 months after the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Time frame: at the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Time frame: 1 month after the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Time frame: 3 months after the start of antidepressants treatment
Clinical outcomes
Clinical outcomes are measured by the HADS
Time frame: 6 months after the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Time frame: At the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Time frame: 1 month after the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Time frame: 3 months after the start of antidepressants treatment
Beliefs about medicines
Patients' beliefs about medicines are measured by the BMQ
Time frame: 6 months after the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Time frame: At the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Time frame: 1 month after the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Time frame: 3 months after the start of antidepressants treatment
Satisfaction with the pharmacist
Patients' satisfaction with the pharmacist is measured by the SWiP
Time frame: 6 months after the start of antidepressants treatment
Feelings about side effects
Patients' feelings about side effects of antidepressants are measured by the FSE
Time frame: 1 month after the start of antidepressants treatment
Feelings about side effects
Patients' feelings about side effects of antidepressants are measured by the FSE
Time frame: 3 months after the start of antidepressants treatment
Feelings about side effects
Patients' feelings about side effects of antidepressants are measured by the FSE
Time frame: 6 months after the start of antidepressants treatment
Satisfaction with treatment
Patients' satisfaction with antidepressants treatment is measured by the SWT
Time frame: 1 month after the start of antidepressants treatment
Satisfaction with treatment
Patients' satisfaction with antidepressants treatment is measured by the SWT
Time frame: 3 months after the start of antidepressants treatment
Satisfaction with treatment
Patients' satisfaction with antidepressants treatment is measured by the SWT
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the start of antidepressants treatment
Enjoyment and satisfaction
Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
Time frame: 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
Time frame: 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
Time frame: 6 months after the start of antidepressants treatment
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