Evaluation of Degree of Dependency After Stroke.

Stroke Sequelae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03451357
• Other study ID #: P17/198 IDIAP Jordi Gol
• Secondary ID: PROJECTE PERIS 2
• Status: Active, not recruiting
• Phase: N/A
• First received: February 25, 2018
• Last updated: February 28, 2018
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: December 31, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dependency
• Stroke
• Stroke Sequelae

Intervention

Diagnostic Test:
• Dependence degree already certificated by Dependence Law.
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.

Locations

Country	Name	City	State
Spain	Jose Luis Clua-Espuny	Tortosa	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Miguel Hernandez University

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Clua-Espuny JL, González-Henares MA, Queralt-Tomas MLL, Campo-Tamayo W, Muria-Subirats E, Panisello-Tafalla A, Lucas-Noll J. Mortality and Cardiovascular Complications in Older Complex Chronic Patients with Type 2 Diabetes. Biomed Res Int. 2017;2017:60784 — View Citation

Clua-Espuny JL, Piñol-Moreso JL, Gil-Guillén FV, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J. [The stroke care system in Terres de l'Ebre, Spain, after the implementation of the Stroke Code model: Ebrictus Study]. Med Clin (Barc). 2012 May 19;138( — View Citation

Clua-Espuny JL, Piñol-Moreso JL, Gil-Guillén VF, Orozco-Beltrán D, Panisello-Tafalla A, Lucas-Noll J, Queralt-Tomás ML, Pla-Farnós R. [Primary and secondary cardiovascular prevention results in patients with stroke: relapse risk and associated survival (E — View Citation

Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, González-Henares MA, Panisello-Tafalla A, López-Pablo C, Lucas-Noll J; Ebrictus Group. Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study. Cerebrovasc Dis Extra. 2015 Oct 9;5(3):95-102. doi: 10.1159/000440734. eCollection 2015 Sep-Dec. — View Citation

Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, González-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten P — View Citation

Gil-Guillen V, Carratala-Munuera C, Ortega JC, Orozco-Beltran D, Ribera JM, Expósito AP, Cánovas PM, Mora EP, Azofra EM, Giménez AF, Lopez-Pineda A, Lorca-Amorrich P, Plaza-Sirvent C, Sola EB, Salas-Rico R, Fernandez-Garcia A. Protective factors in patien — View Citation

Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebric — View Citation

Oliva-Moreno J, Peña-Longobardo LM, Mar J, Masjuan J, Soulard S, Gonzalez-Rojas N, Becerra V, Casado MÁ, Torres C, Yebenes M, Quintana M, Alvarez-Sabín J; CONOCES Investigators Group. Determinants of Informal Care, Burden, and Risk of Burnout in Caregiver — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dependence after the stroke episode	the records will be checked and the patients were contacted and/or by interviewing the person responsible to provide care.	2-year