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Clinical Trials/NCT05611008
NCT05611008
Completed
Not Applicable

Seniors Empowered Via Big Data to Joint-manage Their Medication-related Risk of Falling in Primary Care

University of Amsterdam1 site in 1 country85 target enrollmentNovember 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall
Sponsor
University of Amsterdam
Enrollment
85
Locations
1
Primary Endpoint
Shared decision making
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Falls are a leading cause of injuries among older patients. Medication use is a major risk factor for falls. Because we lack tools to assess individualized risks, general practitioners (GPs) struggle with fall-related medication management for older patients. Furthermore, these older patients are often not properly equipped to engage in the joint management of their medication. A Clinical Decision Support System (CDSS) for GPs and a patient portal for older patients may stimulate shared decision making between GPs and older patients when discussing the medication-related fall risk. The CDSS provides the GP with advice on how to alter medication in such a way that the fall risk decreases, and the patient portal helps the older patient to prepare for a consultation and to engage in the joint management of their medication.

Registry
clinicaltrials.gov
Start Date
November 21, 2022
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julia van Weert

Prof. dr. Julia van Weert

University of Amsterdam

Eligibility Criteria

Inclusion Criteria

  • Aged 70 years or older
  • High fall risk
  • Takes at least 1 Fall Risk Increasing Drug (FRID)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Shared decision making

Time Frame: During consultation

This concerns the extent to which shared decision making between patient and GP during the consultation. This will be assessed using the Observer OPTION Multiple Chronic Conditions (OPTION-MCC). Consultation are audiotaped and will be coded on shared decision making using this coding scheme.

Secondary Outcomes

  • Technology Acceptance Model (TAM; patient portal)(At baseline & two weeks after consultation)
  • Website Satisfaction Scale (WSS; patient portal)(At baseline & two weeks after consultation)
  • Patient portal usage(At baseline & two weeks after consultation)
  • Technology Acceptance Model (TAM; CDSS)(After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months))
  • Netherlands Patient Information Recall Questionnaire (NPIRQ)(Two weeks after consultation)
  • Decisional Conflict Scale (DCS)(Two weeks after consultation)
  • Beliefs About Medicines Questionnaire (BMQ)(Baseline & two weeks after consultation)
  • Changes in medication(Baseline & two weeks after the consultation)
  • Evaluation of the consultation(Immediately after each consultation)
  • The Website Satisfaction Scale (WSS; CDSS)(After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months))

Study Sites (1)

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