Quality of Life Clinical Trial
Official title:
Medication Use and Quality of Life Among Older People
NCT number | NCT05123313 |
Other study ID # | ODIN-1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 26, 2021 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 188 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 80 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Not able to communicate - Does not speak and understand Danish |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense | Region Of Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) | Health-related quality of life will be measured using the Danish version of the Depression List (DL). | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry (CPR). | 3 months | |
Primary | MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry (CPR). | 6 months | |
Primary | MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry (CPR). | 12 months | |
Secondary | COGNITIVE FUNCTION | Cognitive function will be measured using the Danish version of the Mini-Mental State Examination Version 2 Standard Form (MMSE-2). | Baseline, 3 months and 6 months | |
Secondary | FUNCTIONAL LEVEL | Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13). | Baseline, 3 months and 6 months | |
Secondary | HAND-GRIP STRENGTH | Hand-grip strength will be measured using a hand-grip dynamometer. | Baseline, 3 months and 6 months | |
Secondary | NUMBER OF MEDICATION DISCONTINUED | Number of medications discontinued will be assessed through the medication lists. | 3 months, 6 months and 12 months | |
Secondary | NUMBER OF MEDICATION CHANGES | Number of medication changes will be assessed through the medication lists. | 3 months, 6 months and 12 months | |
Secondary | HOSPITAL ADMISSIONS | Hospital admissions will be assessed through the nationwide Danish National Patient Registry. | 3 months, 6 months and 12 months | |
Secondary | HEALTH CARE COSTS | Health care costs will be assessed through nationwide Danish Health Care registries. | 3 months, 6 months and 12 months | |
Secondary | SUCCESS RATE OF THE INTERVENTION | Success rate will be assessed through persisting discontinuations and changes of medications via the medication lists. | 3 months, 6 months and 12 months |
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