Medication Use and Quality of Life Among Older People (Pilot)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Region Of Southern Denmark
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Odense, Region Of Southern Denmark, Danimarca, 5000
- Odense University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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HEALTH-RELATED QUALITY OF LIFE
Lasso di tempo: Baseline
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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Baseline
|
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
Lasso di tempo: 3 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
3 months
|
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
Lasso di tempo: 6 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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6 months
|
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HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
Lasso di tempo: Baseline
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Health-related quality of life will be measured using the Danish version of the Depression List.
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Baseline
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
Lasso di tempo: 3 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
Lasso di tempo: 6 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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6 months
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MORTALITY
Lasso di tempo: 3 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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3 months
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MORTALITY
Lasso di tempo: 6 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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6 months
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MORTALITY
Lasso di tempo: 12 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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LIVELLO FUNZIONALE
Lasso di tempo: Basale, 3 mesi e 6 mesi
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Il livello funzionale sarà misurato utilizzando la versione danese del Vulnerable Elders Survey 13 (VES-13).
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Basale, 3 mesi e 6 mesi
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FORZA DELLA PRESA DELLA MANO
Lasso di tempo: Basale, 3 mesi e 6 mesi
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La forza della presa della mano sarà misurata utilizzando un dinamometro a presa della mano.
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Basale, 3 mesi e 6 mesi
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NUMERO DI CAMBIAMENTI FARMACOLOGICI
Lasso di tempo: 3 mesi, 6 mesi e 12 mesi
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Il numero di modifiche ai farmaci sarà valutato attraverso gli elenchi dei farmaci.
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3 mesi, 6 mesi e 12 mesi
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COGNITIVE FUNCTION
Lasso di tempo: Baseline, 3 months and 6 months
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Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
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Baseline, 3 months and 6 months
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ABILITY TO SIT AND STAND
Lasso di tempo: Baseline, 3 months and 6 months
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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
|
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NUMBER OF MEDICATIONS DISCONTINUED
Lasso di tempo: 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
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HOSPITAL ADMISSIONS
Lasso di tempo: 3 months, 6 months and 12 months
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Admissions will be assessed through the nationwide Danish National Patient Register.
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3 months, 6 months and 12 months
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HEALTH CARE COSTS
Lasso di tempo: 3 months, 6 months and 12 months
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Health care costs.
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3 months, 6 months and 12 months
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SUCCESS RATE OF THE INTERVENTION
Lasso di tempo: 3 months, 6 months and 12 months
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Succes rate of the intervention.
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3 months, 6 months and 12 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Anton Pottegård, Prof, apottegaard@health.sdu.dk
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- ODIN-1 Pilot
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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