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Clinical Trials/NCT04945447
NCT04945447
Recruiting
Not Applicable

Effects of a Pharmacist Intervention in the Primary Sector on Patients Medication and Health-related Quality of Life: A Randomised Controlled Trial

Aalborg University1 site in 1 country400 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polypharmacy Patients
Sponsor
Aalborg University
Enrollment
400
Locations
1
Primary Endpoint
Changes in polypharmacypatients medication
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Brief summary: The randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. The purpose is to gain more knowledge to patients and physicians about their medication and to see changes in the patient's medication and health-related quality of life.

Detailed Description

The main objective of the randomised controlled trial is to investigate the clinical effects of the roll-out of the systematic offer from Nord-KAP in the North Denmark Region at two different levels (medical clinic and patient-level). The primary outcome is changes in the participant's medicine from baseline to follow up and changes in healthcare usage Secondary outcomes include investigation of cost-effectiveness and changes in patients health-related quality of life. The hypothesis is that the regional intervention delivered by the pharmacists, from Nord-KAP, can lead to a decrease in medical products compared with a control group between baseline and at 6-month follow-up. * Will the use of a pharmacists intervention lead to a decrease in the number of polypharmacy patients in medical clinics compared to a control group of medical clinics? * Will the use of a pharmacist intervention lead to an increase in the polypharmacy patients health-related quality of life compared to a control group?

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
January 1, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Josefine Mikkelsen

Principal Investigator

Aalborg University

Eligibility Criteria

Inclusion Criteria

  • Patients with more than 5 medicinal products prescribed besides skin remedies and antibiotic
  • Above 18 years
  • Patients in continuous medication treatment

Exclusion Criteria

  • Terminal patients
  • Patients who are not motivated to comply with the instruction of the trial
  • Do not speak/or understand written Danish
  • Patients lacking legal capacity
  • Patients living at nursing homes

Outcomes

Primary Outcomes

Changes in polypharmacypatients medication

Time Frame: 6 months

The primary outcome at patient level is changes in the patients medication use at baseline and 6-month follow-up defined as the amount of medicine prescribed. Measuring the amount of medicine is extracted by the pharmacist from the participants SMC.

Secondary Outcomes

  • Healthcare services(Up to 10 years)
  • Amount of medicine pr patient in each medical clinic(6 months)
  • Health-related quality of life(6 months)
  • Medical clinic number of polypharmacy patients(6 months)

Study Sites (1)

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