- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02366117
Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems
The study design is that of a cluster randomised controlled trial
The aims of the study were: 1) to assess the quality of care of the residential units for people with long-term mental disorders; 2) to design a training intervention for the staff of the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and 8 months after it ended.
The main outcome variable was level of activity of the users. Secondary outcome variables were the QuIRC dimensions.
The selection of the sample was by residential units for people with long-term mental disorders.
The inclusion criteria were all the middle and high-support residential units in Portugal. Units that had only one type of service users (e.g., mental retardation, dementia) were excluded.
The quality of care of the units was assessed with the QuIRC filled on line by the managers of the units and validated with Service Users Interview Schedule, a face-to-face interview with the users (users that could not give informed consent or collaborate in the interview were excluded).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The development of community services for treating and rehabilitating people with longer term mental disease, including residential units, is a priority throughout Europe. Recent outcome studies have demonstrated encouraging results in rehabilitation program for most people with schizophrenia, event those with high needs.
Recent legislation in Portugal and the approval of the first Mental Health Plan provided a thrust for developing community services for severe mental patients, specially those directed to patients with schizophrenia or schizoaffective disorders.
The recent National Program for Ongoing Care in Mental Health is a unique opportunity to develop even more residential units and highlights the urgent need to evaluate these facilities.
There are no published studies on the quality of these services, nor the impact that teatment and rehabilitation programs may have on the abilities and negative symptoms of their inpatients because, until recently, their were no reliable instruments for this.
The DEMoB.inc (Development of a European Measure of Best Practice for People with Long Term Mental Illness in Institutional Care) study, a multicentric study financed by the European Comission, between 2007-2010, changed this situation. Its primary goal was the development of a a new instrument for evaluating the quality of the care provided and the quality of life in psychiatric residential units and the social sector. Our team was the portuguese partner for the study.
The final version of the instrument now called QuIRC (Quality Indiciator in Rehabilitative Care) is available in portuguese on www.quirc.com. Several articles on this study have been published.
This set of circumstances opens a unique opportunity:
- The creation of more residential units for longer term mental patients.
- The existence of an instrument designed and developed for assessing these facilities.
The urgent need for assessing the quality of care provided in the facilities and the efectivity of their interventions is the primary goal of this study.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Lisboa, Portogallo, 1169-056
- Faculdade de Ciências Médicas
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Mental Health Problems
Exclusion Criteria:
- Refusal to enter the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Training
Data collected during the first pahse of the study will be presented and discussed in a specialist focus group, which will work with the study team as advisors and trainers, to decide on the type of training to be developed. This training intervention will be applied to the facilities presenting half the patient sample size. |
Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.
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Nessun intervento: No Training
Facilities representing half the sample size will not be trained as in the Experimental Arm and continue their standard of care for these patients.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of time spent in any activity during a week by patients
Lasso di tempo: Four months
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The percentage of time spent will be measured by the "Time Use Diary" instrument.
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Four months
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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 (Stima)
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
- 02/2012/CEFCM
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 .