Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Evaluation of Degree of Dependency After Stroke.

Evaluation of Degree of Dependency After Stroke: a Challenge for Health and Social Care Planning.

Understanding the risk of dependence and its severity before hospital discharge for stroke is important for health and social care planning as instrument to prioritize people where the assistance is more appropriate in a context o limited resources and avoid the gap across the health care continuum. The goal is to conduct an assessment, which will identify the patient's needs. In doing so, the team, along with family may effectively coordinate, plan and implement any steps necessary to ensure a safe and healthy environment for the patient.

The main study's objective is to asses which factors are associated with outcome of dependence after stroke and propose a suitable instrument for identifying patients in higher risk for needing formal care from health and/or social care providers.

Panoramica dello studio

Descrizione dettagliata

Study Design It is a prospective, longitudinal, multicenter and community study, with a 2-year follow-up period (from 01.01.2017 to 31.12.2018) of patients who suffered stroke in the Community of Catalonia, Terres De l'Ebre County from the population-based register through specific ICD-9 diagnostic and procedure codes.

Data collection methods Probabilistic sample: all consecutive stroke cases up to reaching the previously calculated sample size. Study will be carried out according the common clinical practice.

Primary outcome: The primary outcome was dependence occurring within the 2-year follow-up after the stroke episode. Assessment of the patients' degree of dependency is essential in determining nursing care needs, planning nursing intervention, helping increase patients' abilities, and creating proper discharge plans. The European Council [12,13] defines dependence as the state in which people, due to causes linked to the lack or loss of physical, psychological, or intellectual autonomy, are in need of assistance and/or significant help to carry out common activities of daily life. In primary care, the nurses in charge are trained of data collection. This situation needs of formal care provided by health or/and social workers, private or public.

Secondary outcomes:

  1. Propose a suitable instrument with predictive power propose for identifying patients in higher risk for needing formal care from health and/or social care providers.
  2. Measure the time elapsed from the hospital discharge to first contact with health primary care services, with social services, application for recognition of dependence degree, and get effective certification.
  3. Know the newly diagnosed cases of dependence after stroke.

Statistical analysis All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. Predictions of dependence risk were based on Cox proportional-hazard regression models. Data analysis information extracted included the adjusted risk estimates and 95% confidence intervals (CI) and all statistical tests were two sided at the 5% significance level.

All potential predictors were considered in a multivariate logistic regression, and a backward step selection procedure was carried out to pick the variables that composed the best model. Subsequently, design of a predictive model of multivariate Cox regression analysis was utilized to define the weight of each of the pathologies in the dependence. To assign the weight according to the hazard ratio (HR) value, we took into account only those with a HR ≥1.2 in the multivariate model approximating the value of HR to the nearest whole number:

  • HR between 1.20 and 1.49 scored a 1.
  • HR between 1.50 and 2.49 was a 2.
  • HR between 2.50 and 3.49 received 3, and so on. The final score for each patient will be made up of the sum of their scores. We will use ROC curves and the AUC to assess the ability of this tool to stratify patients and predict dependence. To ensure internal validity, we will perform a ten-fold cross-validated multivariate regularized logistic regression to predict dependence status based on all other variables. We will plot the receiver operating characteristic (ROC) curves and compute the area under curve (AUC) to assess the prediction power of the models. In a next phase, there will be a prospective study of validation in the cohort of patients with an episode of stroke along 2018 year.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

230

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Tarragona
      • Tortosa, Tarragona, Spagna, 43500
        • Jose Luis Clua-Espuny

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

It is a prospective, longitudinal, multicenter and community study, with a 2-year follow-up period (from 01.01.2017 to 31.12.2018) of patients who suffered stroke in the Community of Catalonia, Terres De l'Ebre County from the population-based register through specific ICD-9 diagnostic and procedure codes.

The study variables were collected while the patients remained in the stroke units (visit 1) and at the follow-up visits at 6 months (visit 2), 12 months (visit 3), 18 months (visit 4) and 24 months (study ending). Predictor variables were considered if they were viewed as commonly measured and available in primary care and had potential evidence of an association with dependence risk.

Descrizione

Inclusion Criteria:

  • Patients who has suffered acute stroke, with residence at the county for last 5 years, at least and registered clinical history in anyone health center of the county, primary care or hospital; and availability of informed consent document.

Exclusion Criteria:

  • No availability or accessibility to enough information to complete the study: clinical report in primary care, hospital or social services.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
patients with Dependence degree
Dependence degree already certificated by Dependence Law: It is calculated by accepting an expected proportion of 40% patients with dependence, with a precision 6.5% and confidence level of 95%, obtaining a N= 200 patients. Assuming a 15% of loses, we estimate we will need N=230 to be followed. This sample size would enable us to construct logistic regression models including simultaneously up to 5 predictive factors to assess the relationship between each of the independent variables and the occurrence of dependency.
The European Council defines dependence as the state in which people, due to causes linked to the lack or loss of physical, psychological, or intellectual autonomy, are in need of assistance and/or significant help to carry out common activities of daily life. In primary care, the nurses in charge are trained of data collection. This situation needs of formal care provided by health or/and social workers, private or public.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dependence after the stroke episode
Lasso di tempo: 2-year
the records will be checked and the patients were contacted and/or by interviewing the person responsible to provide care.
2-year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: JOSE L CLUA-ESPUNY, PhD, IDIAP Jordi Gol
  • Direttore dello studio: CONCEPCION CARRATALA-MUNUERA, PhD, Universidad Miguel Hernandez de Elche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2017

Completamento primario (Effettivo)

1 gennaio 2018

Completamento dello studio (Anticipato)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

25 febbraio 2018

Primo inviato che soddisfa i criteri di controllo qualità

28 febbraio 2018

Primo Inserito (Effettivo)

1 marzo 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 marzo 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 febbraio 2018

Ultimo verificato

1 febbraio 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • P17/198 IDIAP Jordi Gol
  • PROJECTE PERIS 2016 (Altro numero di sovvenzione/finanziamento: PERIS (2016-2020).)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The data that support the findings of this study are available from the corresponding author on reasonable request.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

Prove cliniche su Sequele di ictus

Sottoscrivi