Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants

Depression Clinical Trial

— SIMCA  

Official title:

Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187380
• Other study ID #: B32220109082
• Secondary ID: s52518
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: July 9, 2014
• Start date: June 2010

Study information

• Verified date: July 2014
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years old

• able to understand and complete Dutch questionnaires

• could be reached by telephone for follow-up

Exclusion Criteria:

• used antidepressants over the last six months

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antidepressant
• Depression

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	Medication adherence measured by the MMAS-8	1 month after start of antidepressants treatment	No
Primary	Medication adherence	Medication adherence measured by the MMAS-8	3 months after start of antidepressants treatment	No
Primary	Medication adherence	Medication adherence measured by the MMAS-8	6 months after start of antidepressants treatment	No
Secondary	Economic outcomes	Economic outcomes are measured by the WPAI	at the start of antidepressants treatment	No
Secondary	Economic outcomes	Economic outcomes are measured by the WPAI	1 month after the start of antidepressants treatment	No
Secondary	Economic outcomes	Economic outcomes are measured by the WPAI	3 months after the start of antidepressants treatment	No
Secondary	Economic outcomes	Economic outcomes are measured by the WPAI	6 months after the start of antidepressants treatment	No
Secondary	Clinical outcomes	Clinical outcomes are measured by the HADS	at the start of antidepressants treatment	No
Secondary	Clinical outcomes	Clinical outcomes are measured by the HADS	1 month after the start of antidepressants treatment	No
Secondary	Clinical outcomes	Clinical outcomes are measured by the HADS	3 months after the start of antidepressants treatment	No
Secondary	Clinical outcomes	Clinical outcomes are measured by the HADS	6 months after the start of antidepressants treatment	No
Secondary	Beliefs about medicines	Patients' beliefs about medicines are measured by the BMQ	At the start of antidepressants treatment	No
Secondary	Beliefs about medicines	Patients' beliefs about medicines are measured by the BMQ	1 month after the start of antidepressants treatment	No
Secondary	Beliefs about medicines	Patients' beliefs about medicines are measured by the BMQ	3 months after the start of antidepressants treatment	No
Secondary	Beliefs about medicines	Patients' beliefs about medicines are measured by the BMQ	6 months after the start of antidepressants treatment	No
Secondary	Satisfaction with the pharmacist	Patients' satisfaction with the pharmacist is measured by the SWiP	At the start of antidepressants treatment	No
Secondary	Satisfaction with the pharmacist	Patients' satisfaction with the pharmacist is measured by the SWiP	1 month after the start of antidepressants treatment	No
Secondary	Satisfaction with the pharmacist	Patients' satisfaction with the pharmacist is measured by the SWiP	3 months after the start of antidepressants treatment	No
Secondary	Satisfaction with the pharmacist	Patients' satisfaction with the pharmacist is measured by the SWiP	6 months after the start of antidepressants treatment	No
Secondary	Feelings about side effects	Patients' feelings about side effects of antidepressants are measured by the FSE	1 month after the start of antidepressants treatment	No
Secondary	Feelings about side effects	Patients' feelings about side effects of antidepressants are measured by the FSE	3 months after the start of antidepressants treatment	No
Secondary	Feelings about side effects	Patients' feelings about side effects of antidepressants are measured by the FSE	6 months after the start of antidepressants treatment	No
Secondary	Satisfaction with treatment	Patients' satisfaction with antidepressants treatment is measured by the SWT	1 month after the start of antidepressants treatment	No
Secondary	Satisfaction with treatment	Patients' satisfaction with antidepressants treatment is measured by the SWT	3 months after the start of antidepressants treatment	No
Secondary	Satisfaction with treatment	Patients' satisfaction with antidepressants treatment is measured by the SWT	6 months after the start of antidepressants treatment	No
Secondary	Satisfaction with information regarding treatment	Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE	At the start of antidepressants treatment	No
Secondary	Satisfaction with information regarding treatment	Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE	1 month after the start of antidepressants treatment	No
Secondary	Satisfaction with information regarding treatment	Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE	3 months after the start of antidepressants treatment	No
Secondary	Satisfaction with information regarding treatment	Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE	6 months after the start of antidepressants treatment	No
Secondary	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	At the start of antidepressants treatment	No
Secondary	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	1 month after the start of antidepressants treatment	No
Secondary	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	3 months after the start of antidepressants treatment	No
Secondary	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	6 months after the start of antidepressants treatment	No
Secondary	Health-related quality of life	Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D	At the start of antidepressants treatment	No
Secondary	Health-related quality of life	Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D	1 month after the start of antidepressants treatment	No
Secondary	Health-related quality of life	Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D	3 months after the start of antidepressants treatment	No
Secondary	Health-related quality of life	Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D	6 months after the start of antidepressants treatment	No
Secondary	Enjoyment and satisfaction	Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q	At the start of antidepressants treatment	No
Secondary	Enjoyment and satisfaction	Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q	1 month after the start of antidepressants treatment	No
Secondary	Enjoyment and satisfaction	Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q	3 months after the start of antidepressants treatment	No
Secondary	Enjoyment and satisfaction	Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q	6 months after the start of antidepressants treatment	No