NCT05526963

Brief Summary

Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

August 31, 2022

Last Update Submit

January 7, 2025

Conditions

PolypharmacyMultimorbidity

Keywords

Primary CarePolypharmacyMultimorbidityDrug-Related Side Effects and Adverse Reactions

Outcome Measures

Primary Outcomes (1)

  • Rate of adverse drug reactions

    Rate of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care.

    6 months

Secondary Outcomes (8)

  • Potentially inappropriate prescriptions

    6 months

  • Hospitalizations

    6 months

  • Adherence

    6 months

  • Health-related quality of life

    6 months

  • Family doctor consultations

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Medication review (STOPP/START-criteria) + telephone-based adherence support measure (motivational interviewing)

Other: Medication plan reviewBehavioral: Adherence support

Control Group

NO INTERVENTION

Usual care

Interventions

Medication plan reviewOTHER

Intervention group patients will receive a revised medication plan by external pharmacologist based on the the STOPP/START criteria. The revised medication plan will be provided to the family physician who then will provide it to the patient. The revision comes along with evidence based information for the physician to prevent possible uncertainties by the physicians.

Intervention Group
Adherence supportBEHAVIORAL

Intervention group patients will receive a study nurse administered adherence support measure based on telephone-based motivational interviewing. The measure includes information on possible consequences of inadherence and signs of adverse drug reactions that is comprehensible for lay persons.

Intervention Group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 5 longterm medications (\> 6 months) (polypharmacy)
  • ≥ 3 chronic diseases (multimorbidity)
  • ≥ 1 family doctor consultation within the last 6 months

You may not qualify if:

  • Patients with a critically reduced life expectancy
  • Patients who cannot autonomously visit the family practice
  • Patients who cannot participate in the informed consent process
  • Patients who are residing in a nursing home
  • Patients with dementia or a mental of behavioral disorder ICD-10 F00-F99
  • Patients who are participating in another medical study with a focus on polypharmacy or multimorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAP ANZ

Halle, Saxony-Anhalt, 06110, Germany

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Thomas Frese, Prof.

    MLU Halle-Wittenberg

    STUDY CHAIR

Central Study Contacts

Alexander Bauer, Dr.

CONTACT

+493455575338raphael@uk-halle.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stepped-wedge cluster-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reserach Coordinator

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

May 30, 2024

Primary Completion

October 30, 2025

Study Completion

December 31, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

DE(1)