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

NCT02187380 | Completed

• 2 other identifiers: B32220109082s52518
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Antidepressant

Outcome Measures

Primary Outcomes (3)

• Medication adherence

  Medication adherence measured by the MMAS-8

  1 month after start of antidepressants treatment

• Medication adherence

  Medication adherence measured by the MMAS-8

  3 months after start of antidepressants treatment

• Medication adherence

  Medication adherence measured by the MMAS-8

  6 months after start of antidepressants treatment

Secondary Outcomes (38)

• Economic outcomes

  at the start of antidepressants treatment

• Economic outcomes

  1 month after the start of antidepressants treatment

• Economic outcomes

  3 months after the start of antidepressants treatment

• Economic outcomes

  6 months after the start of antidepressants treatment

• Clinical outcomes

  at the start of antidepressants treatment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care patients with a new prescription for antidepressants in Flanders, Belgium.

You may qualify if:

• at least 18 years old
• able to understand and complete Dutch questionnaires
• could be reached by telephone for follow-up

You may not qualify if:

• used antidepressants over the last six months

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sophie Liekens, M Psy

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M Psy

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

BE (1)