Quality of Life Clinical Trial
Official title:
Medication Use and Quality of Life Among Older People (Pilot)
NCT number | NCT04676984 |
Other study ID # | ODIN-1 Pilot |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | July 8, 2021 |
Verified date | April 2022 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | July 8, 2021 |
Est. primary completion date | April 12, 2021 |
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 =15 - 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 SF-12v2 Health Survey. | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) | Health-related quality of life will be measured using the Danish version of the Depression List. | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry. | 3 months | |
Primary | MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry. | 6 months | |
Primary | MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry. | 12 months | |
Secondary | COGNITIVE FUNCTION | Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form. | 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 | ABILITY TO SIT AND STAND | Ability to sit and stand will be measured via the 30-second stand-sit-test. | Baseline, 3 months and 6 months | |
Secondary | NUMBER OF MEDICATIONS DISCONTINUED | Number of medications dicontinued 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 | Admissions will be assessed through the nationwide Danish National Patient Register. | 3 months, 6 months and 12 months | |
Secondary | HEALTH CARE COSTS | Health care costs. | 3 months, 6 months and 12 months | |
Secondary | SUCCESS RATE OF THE INTERVENTION | Succes rate of the intervention. | 3 months, 6 months and 12 months |
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