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Completed

NCT Number: NCT02187380

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

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.

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Key information

Conditions

Depression Antidepressant Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Medication adherence

    Time frame: 1 month after start of antidepressants treatment

    Medication adherence measured by the MMAS-8

  2. Medication adherence

    Time frame: 3 months after start of antidepressants treatment

    Medication adherence measured by the MMAS-8

  3. Medication adherence

    Time frame: 6 months after start of antidepressants treatment

    Medication adherence measured by the MMAS-8

Secondary outcomes

  1. Economic outcomes

    Time frame: at the start of antidepressants treatment

    Economic outcomes are measured by the WPAI

  2. Economic outcomes

    Time frame: 1 month after the start of antidepressants treatment

    Economic outcomes are measured by the WPAI

  3. Economic outcomes

    Time frame: 3 months after the start of antidepressants treatment

    Economic outcomes are measured by the WPAI

  4. Economic outcomes

    Time frame: 6 months after the start of antidepressants treatment

    Economic outcomes are measured by the WPAI

  5. Clinical outcomes

    Time frame: at the start of antidepressants treatment

    Clinical outcomes are measured by the HADS

  6. Clinical outcomes

    Time frame: 1 month after the start of antidepressants treatment

    Clinical outcomes are measured by the HADS

  7. Clinical outcomes

    Time frame: 3 months after the start of antidepressants treatment

    Clinical outcomes are measured by the HADS

  8. Clinical outcomes

    Time frame: 6 months after the start of antidepressants treatment

    Clinical outcomes are measured by the HADS

  9. Beliefs about medicines

    Time frame: At the start of antidepressants treatment

    Patients' beliefs about medicines are measured by the BMQ

  10. Beliefs about medicines

    Time frame: 1 month after the start of antidepressants treatment

    Patients' beliefs about medicines are measured by the BMQ

  11. Beliefs about medicines

    Time frame: 3 months after the start of antidepressants treatment

    Patients' beliefs about medicines are measured by the BMQ

  12. Beliefs about medicines

    Time frame: 6 months after the start of antidepressants treatment

    Patients' beliefs about medicines are measured by the BMQ

  13. Satisfaction with the pharmacist

    Time frame: At the start of antidepressants treatment

    Patients' satisfaction with the pharmacist is measured by the SWiP

  14. Satisfaction with the pharmacist

    Time frame: 1 month after the start of antidepressants treatment

    Patients' satisfaction with the pharmacist is measured by the SWiP

  15. Satisfaction with the pharmacist

    Time frame: 3 months after the start of antidepressants treatment

    Patients' satisfaction with the pharmacist is measured by the SWiP

  16. Satisfaction with the pharmacist

    Time frame: 6 months after the start of antidepressants treatment

    Patients' satisfaction with the pharmacist is measured by the SWiP

  17. Feelings about side effects

    Time frame: 1 month after the start of antidepressants treatment

    Patients' feelings about side effects of antidepressants are measured by the FSE

  18. Feelings about side effects

    Time frame: 3 months after the start of antidepressants treatment

    Patients' feelings about side effects of antidepressants are measured by the FSE

  19. Feelings about side effects

    Time frame: 6 months after the start of antidepressants treatment

    Patients' feelings about side effects of antidepressants are measured by the FSE

  20. Satisfaction with treatment

    Time frame: 1 month after the start of antidepressants treatment

    Patients' satisfaction with antidepressants treatment is measured by the SWT

  21. Satisfaction with treatment

    Time frame: 3 months after the start of antidepressants treatment

    Patients' satisfaction with antidepressants treatment is measured by the SWT

  22. Satisfaction with treatment

    Time frame: 6 months after the start of antidepressants treatment

    Patients' satisfaction with antidepressants treatment is measured by the SWT

  23. Satisfaction with information regarding treatment

    Time frame: At the start of antidepressants treatment

    Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE

  24. Satisfaction with information regarding treatment

    Time frame: 1 month after the start of antidepressants treatment

    Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE

  25. Satisfaction with information regarding treatment

    Time frame: 3 months after the start of antidepressants treatment

    Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE

  26. Satisfaction with information regarding treatment

    Time frame: 6 months after the start of antidepressants treatment

    Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE

  27. Satisfaction with information regarding side effects

    Time frame: At the start of antidepressants treatment

    Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE

  28. Satisfaction with information regarding side effects

    Time frame: 1 month after the start of antidepressants treatment

    Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE

  29. Satisfaction with information regarding side effects

    Time frame: 3 months after the start of antidepressants treatment

    Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE

  30. Satisfaction with information regarding side effects

    Time frame: 6 months after the start of antidepressants treatment

    Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE

  31. Health-related quality of life

    Time frame: At the start of antidepressants treatment

    Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D

  32. Health-related quality of life

    Time frame: 1 month after the start of antidepressants treatment

    Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D

  33. Health-related quality of life

    Time frame: 3 months after the start of antidepressants treatment

    Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D

  34. Health-related quality of life

    Time frame: 6 months after the start of antidepressants treatment

    Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D

  35. Enjoyment and satisfaction

    Time frame: At the start of antidepressants treatment

    Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q

  36. Enjoyment and satisfaction

    Time frame: 1 month after the start of antidepressants treatment

    Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q

  37. Enjoyment and satisfaction

    Time frame: 3 months after the start of antidepressants treatment

    Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q

  38. Enjoyment and satisfaction

    Time frame: 6 months after the start of antidepressants treatment

    Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: SIMCA

Important dates

Study start
2010
Primary completion
2012
First posted
Jul 11, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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