Medication Use and Quality of Life Among Older People

NCT05123313 | Active Not Recruiting

• 1 other identifier: ODIN-1
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Reduction, Harm

Keywords

Deprescribing; Polypharmacy; Shared decision-making; Guideline

Outcome Measures

Primary Outcomes (9)

• HEALTH-RELATED QUALITY OF LIFE

  Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).

  Baseline

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

  Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).

  3 months

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

  Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).

  6 months

• HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)

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

  Baseline

• CHANGE FROM BASLINE 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 (DL).

  3 months

• CHANGE FROM BASLINE 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 (DL).

  6 months

• MORTALITY

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

  3 months

• MORTALITY

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

  6 months

• MORTALITY

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

  12 months

Secondary Outcomes (8)

• 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

• NUMBER OF MEDICATION DISCONTINUED

  3 months, 6 months and 12 months

• NUMBER OF MEDICATION CHANGES

  3 months, 6 months and 12 months

Study Arms (2)

Control group

NO INTERVENTION

The control group will not receive a series of consultations with their general practitioner. Controls will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.

Intervention group

EXPERIMENTAL

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. Interventions will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.

Behavioral: Deprescribing intervention

Interventions

Deprescribing intervention BEHAVIORAL

The intervention is comprised of a minimum of three consultations with a general practitioner (GP), where adjustment of the patient's medication is made according to the patient's preference, goals and needs Consultation 1: Patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. Consultation 2: A clinical pharmacist have beforehand examined the patient's medication list and provided suggestions to the GP on which drugs can be deprescribed. The patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. Consultation 3: Patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

Intervention group

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older 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 ≥18
• Are able to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anton Pottegård, Professor

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 17, 2021
• Study Start: October 26, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)