- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04676984
Medication Use and Quality of Life Among Older People (Pilot)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).
The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Region Of Southern Denmark
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Odense, Region Of Southern Denmark, Danmark, 5000
- Odense University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Consultations
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
HEALTH-RELATED QUALITY OF LIFE
Tidsramme: Baseline
|
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
Tidsramme: 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
Tidsramme: 6 months
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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)
Tidsramme: Baseline
|
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
Tidsramme: 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
Tidsramme: 6 months
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
6 months
|
|
MORTALITY
Tidsramme: 3 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
3 months
|
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MORTALITY
Tidsramme: 6 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
6 months
|
|
MORTALITY
Tidsramme: 12 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
FUNKTIONSNIVEAU
Tidsramme: Baseline, 3 måneder og 6 måneder
|
Funktionsniveau vil blive målt ved hjælp af den danske version af Udsatte Ældreundersøgelse 13 (VES-13).
|
Baseline, 3 måneder og 6 måneder
|
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HÅNDGRIPSSTYRKE
Tidsramme: Baseline, 3 måneder og 6 måneder
|
Håndgrebsstyrken vil blive målt ved hjælp af et håndgrebsdynamometer.
|
Baseline, 3 måneder og 6 måneder
|
|
ANTAL MEDICINÆNDRINGER
Tidsramme: 3 måneder, 6 måneder og 12 måneder
|
Antal medicinændringer vil blive vurderet gennem medicinlisterne.
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3 måneder, 6 måneder og 12 måneder
|
|
COGNITIVE FUNCTION
Tidsramme: Baseline, 3 months and 6 months
|
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
|
|
ABILITY TO SIT AND STAND
Tidsramme: Baseline, 3 months and 6 months
|
Ability to sit and stand will be measured via the 30-second stand-sit-test.
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Baseline, 3 months and 6 months
|
|
NUMBER OF MEDICATIONS DISCONTINUED
Tidsramme: 3 months, 6 months and 12 months
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Number of medications dicontinued will be assessed through the medication lists.
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3 months, 6 months and 12 months
|
|
HOSPITAL ADMISSIONS
Tidsramme: 3 months, 6 months and 12 months
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Admissions will be assessed through the nationwide Danish National Patient Register.
|
3 months, 6 months and 12 months
|
|
HEALTH CARE COSTS
Tidsramme: 3 months, 6 months and 12 months
|
Health care costs.
|
3 months, 6 months and 12 months
|
|
SUCCESS RATE OF THE INTERVENTION
Tidsramme: 3 months, 6 months and 12 months
|
Succes rate of the intervention.
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3 months, 6 months and 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anton Pottegård, Prof, apottegaard@health.sdu.dk
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ODIN-1 Pilot
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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