- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02295462
Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial (EPCentCare)
Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.
Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nordrhein-Westfalen
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Witten Herdecke, Nordrhein-Westfalen, Germania, 58448
- Universität Witten/Herdecke
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Sachsen-Anhalt
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Halle (Saale), Sachsen-Anhalt, Germania, 06110
- Martin-Luther-Universität Halle-Wittenberg
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germania, 23562
- University of Luebeck
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
On cluster level
Inclusion Criteria:
- nursing homes with at least 50 residents
Exclusion Criteria:
- other ongoing trial in the institution
On individual level
Inclusion Criteria:
- all residents within a cluster are eligible to participate in the study
Exclusion Criteria:
- diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
- respite care
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Person-centered Care
Medication Review + Person-centered Care
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Medication Review + Person-centered Care
Medication Review only
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Comparatore attivo: Optimised Treatment
Medication Review
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Medication Review only
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Proportion of residents receiving at least one antipsychotic medication after 12 months
Lasso di tempo: 12 months
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12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Residents' quality of life
Lasso di tempo: 12 months
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Will be measured with the QoL-AD
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12 months
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Behavioural and psychological symptoms of dementia
Lasso di tempo: 12 months
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Will be measured with the CMAI
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12 months
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Costs within trial period
Lasso di tempo: 12 months
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Cost parameters will be collected alongside the trial on intervention-related components as well as outcome-related components.
Costs which are explicitly trial-associated will not be taken into account for cost analysis.
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12 months
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Falls and fall-related medical attention
Lasso di tempo: 12 months
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12 months
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Physical restraints within study period
Lasso di tempo: 12 months
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Physical restraints will be assessed retrospectively by data extraction from residents' records- The following devices will be assessed: bilateral bedrails, belts, fixed tables, and other measures limiting free body movement.
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12 months
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Median daily dose of antipsychotics in chlorpromazine equivalents within study period
Lasso di tempo: 12 months
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Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
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12 months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Process evaluation
Lasso di tempo: 12 months
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Different methods will be used for data collection: investigators documentation, questionnaires on staff knowledge and self-efficacy, structured interviews and in depth-interviews with staff.
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12 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Gabriele Meyer, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg
Pubblicazioni e link utili
Pubblicazioni generali
- Richter C, Fleischer S, Langner H, Meyer G, Balzer K, Kopke S, Sonnichsen A, Loscher S, Berg A. Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory. BMC Nurs. 2022 Jul 8;21(1):182. doi: 10.1186/s12912-022-00963-6.
- Richter C, Berg A, Langner H, Meyer G, Kopke S, Balzer K, Wolschon EM, Silies K, Sonnichsen A, Loscher S, Haastert B, Icks A, Wolf U, Fleischer S. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial. Age Ageing. 2019 May 1;48(3):419-425. doi: 10.1093/ageing/afz016.
- Dichter MN, Wolschon EM, Schwab CGG, Meyer G, Kopke S. Item distribution and inter-rater reliability of the German version of the quality of life in Alzheimer's disease scale (QoL-AD) proxy for people with dementia living in nursing homes. BMC Geriatr. 2018 Jun 19;18(1):145. doi: 10.1186/s12877-018-0834-z.
- Richter C, Berg A, Fleischer S, Kopke S, Balzer K, Fick EM, Sonnichsen A, Loscher S, Vollmar HC, Haastert B, Icks A, Dintsios CM, Mann E, Wolf U, Meyer G. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial. Implement Sci. 2015 Jun 4;10:82. doi: 10.1186/s13012-015-0268-3.
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EPCentCare
- 01GY1335A (Altro numero di sovvenzione/finanziamento: German Federal Ministry of Education and Research)
- 01GY1335B (Altro numero di sovvenzione/finanziamento: German Federal Ministry of Education and Research)
- 01GY1335C (Altro numero di sovvenzione/finanziamento: German Federal Ministry of Education and Research)
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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