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AgingSIMENONNCT03179722

Studying the Impact of a Medication Use Evaluation by the Community Pharmacist

A study testing Medication review and Additional data collection: questionnaires in people with Aging, run by Joke Wuyts.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an intermediate medication review. For each patient, the identified drug-related problems and subsequent interventions are registered using the PharmDisc classification. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Medication review and Additional data collection: questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
453 participants
Where
No sites listed yet
Study dates
8 Nov 2016to 30 Oct 2018
Phase
Interventional
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 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Patients should be 70 years or older
  • Use five or more drugs on a regular basis (prescription or non-prescription drugs)
  • Live in the ambulatory setting
  • Obtain his medication from this pharmacy on a regular basis

Who cannot join

  • -

About this study

In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an intermediate medication review. For each patient, the identified drug-related problems and subsequent interventions are registered using the PharmDisc classification. In a subset of Dutch speaking patients, a pretest-posttest single group design is used to measure the impact of this review on patient related outcomes using questionnaires. The primary outcome is the medication related quality of life, measured via the living with medicines questionnaire. Other patient reported outcomes include adherence, self-management, patient satisfaction, fall incidents and use of emergency healthcare services. Medication records are also collected to objectively measure adherence before and after the intervention.

Conditions
Aging
Being tested
Medication review, Additional data collection: questionnaires
Keywords
Aging, Drug-related problems, Medication review, Community pharmacist, Medication use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication reviewBehavioural

    Also called Medication use review, Medication review type 2a, Intermediate medication review

    The intervention consists of a medicines use review provided by community pharmacists in Belgium. A medicines use review is a medication review type 2a in which both a patient interview and dispensing data are used as information sources to identify drug-related problems with a specific focus on the medicines use of the patient.

  • Additional data collection: questionnairesBehavioural

    Pre-post study design.

    At three timepoints, data is collected:

    • before the medication review (T-1week)
    • during the review (Tweek 3)
    • after the review (Tweek12) The questionnaire provide data for the outcomes: medication related quality of life, adherence questionnaire, service satisfaction, use of emergency health services, self-management
Study groups in NCT03179722
Study groupRoleWhat they receive
Intervention group: Frenchspeaking patientsExperimentalIntervention: Medication review
Receives: Behavioral: Medication review
Intervention group: Dutchspeaking patientsExperimentalIntervention: Medication review Intervention: Dutchspeaking patients are also invited to participate to Additional data collection: questionnaires
Receives: Behavioral: Medication review; Behavioral: Additional data collection: questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug-related problems & interventions

    Using the validated PharmDisc classification tool

    Measured: One timeframe: during the medication review

  2. Change in medication related quality of life

    using the Living with medicines questionnaire

    Measured: Three timepoints: Before the review, during review (week 3), after the review (week 12)

Secondary outcomes (5)

  1. Change in adherence

    using dispensing data

    Measured: 9 months before and after the intervention

  2. Change in adherence

    using the PROMAS questionnaire

    Measured: Two timepoints: Before the review, after the review (week 12)

  3. Change in self-management

    using the PAM questionnaire

    Measured: Two timepoints: Before the review, after the review (week 12)

  4. Change in use of emergency healthcare services & fall incidents

    using own questions

    Measured: Two timepoints: Before the review, after the review (week 12)

  5. Satisfaction with the new service

    Using the PSPSQ2 questionnaire

    Measured: One timepoint: during the review (week 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start8 Nov 2016
  3. Primary completion11 Oct 2017
  4. Study completion30 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel group intervention study. In a subset of 140 patients, a pre-post study design is used.
Masking
None (open label)
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179722
Sponsor's protocol ID
SIMENONv3
Acronym
SIMENON
Status last verified
Jul 2019
First submitted
1 Jun 2017
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wuyts J, Maesschalck J, De Wulf I, Foubert K, Boussery K, De Lepeleire J, Foulon V. Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol. BMC Health Serv Res. 2018 Aug 8;18(1):623. doi: 10.1186/s12913-018-3440-z.

    PubMed 30089523

Questions about this trial

What is this clinical trial studying?

A study testing Medication review and Additional data collection: questionnaires in people with Aging, run by Joke Wuyts.

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 4 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Drug-related problems & interventions (time frame: One timeframe: during the medication review). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03179722, which also lists 1 linked publication.

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 24 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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