NCT04676984

Brief Summary

This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

December 1, 2020

Last Update Submit

April 19, 2022

Conditions

Quality of LifeReduction, Harm

Keywords

DeprescribingPolypharmacyGuideline

Outcome Measures

Primary Outcomes (9)

  • HEALTH-RELATED QUALITY OF LIFE

    Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.

    Baseline

  • CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS

    Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.

    3 months

  • CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS

    Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.

    6 months

  • HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)

    Health-related quality of life will be measured using the Danish version of the Depression List.

    Baseline

  • CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS

    Health-related quality of life will be measured using the Danish version of the Depression List.

    3 months

  • CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS

    Health-related quality of life will be measured using the Danish version of the Depression List.

    6 months

  • MORTALITY

    Mortality will be assessed through the nationwide Danish Central Person Registry.

    3 months

  • MORTALITY

    Mortality will be assessed through the nationwide Danish Central Person Registry.

    6 months

  • MORTALITY

    Mortality will be assessed through the nationwide Danish Central Person Registry.

    12 months

Secondary Outcomes (9)

  • COGNITIVE FUNCTION

    Baseline, 3 months and 6 months

  • FUNCTIONAL LEVEL

    Baseline, 3 months and 6 months

  • HAND-GRIP STRENGTH

    Baseline, 3 months and 6 months

  • ABILITY TO SIT AND STAND

    Baseline, 3 months and 6 months

  • NUMBER OF MEDICATIONS DISCONTINUED

    3 months, 6 months and 12 months

  • +4 more secondary outcomes

Study Arms (1)

Consultations

OTHER

The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.

Other: Consultations

Interventions

ConsultationsOTHER

The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.

Consultations

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged ≥80 years
  • Take ≥8 different medications
  • Have a life expectancy of \<2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
  • Have a Mini-Mental State Exam (MMSE) score of ≥15
  • Are able to provide informed consent

You may not qualify if:

  • Not able to communicate
  • Does not speak and understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Harm Reduction

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Anton Pottegård, Prof

    apottegaard@health.sdu.dk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 21, 2020

Study Start

June 1, 2020

Primary Completion

April 12, 2021

Study Completion

July 8, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)