Evaluation of Degree of Dependency After Stroke.

NCT03451357 | Unknown DMC

• 2 other identifiers: P17/198 IDIAP Jordi GolPROJECTE PERIS 2016
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke Sequelae; Dependency

Keywords

stroke; dependence degree; social care; health care; disability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Diagnostic Test: Dependence degree already certificated by Dependence Law.

Interventions

Dependence degree already certificated by Dependence Law. DIAGNOSTIC_TEST

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.

patients with Dependence degree

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Universidad Miguel Hernandez de Elche: collaborator

Study Sites (1)

Jose Luis Clua-Espuny

Tortosa, Tarragona, 43500, Spain

Location

Related Publications (8)

• Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, Gonzalez-Henares MA, Panisello-Tafalla A, Lopez-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.

  PMID: 26648964 BACKGROUND

• Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, Gonzalez-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten Primaria. 2015 Feb;47(2):108-16. doi: 10.1016/j.aprim.2014.04.008. Epub 2014 Jun 19. Spanish.

  PMID: 24953174 RESULT

• Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen VF, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J, Queralt-Tomas ML, Pla-Farnos R. [Primary and secondary cardiovascular prevention results in patients with stroke: relapse risk and associated survival (Ebrictus study)]. Rev Neurol. 2012 Jan 16;54(2):81-92. Spanish.

  PMID: 22234566 RESULT

• Clua-Espuny JL, Gonzalez-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;2017:6078498. doi: 10.1155/2017/6078498. Epub 2017 Aug 10.

  PMID: 28856160 RESULT

• 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 Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.

  PMID: 27113062 RESULT

• Gil-Guillen V, Carratala-Munuera C, Ortega JC, Orozco-Beltran D, Ribera JM, Exposito AP, Canovas PM, Mora EP, Azofra EM, Gimenez AF, Lopez-Pineda A, Lorca-Amorrich P, Plaza-Sirvent C, Sola EB, Salas-Rico R, Fernandez-Garcia A. Protective factors in patients aged over 65 with stroke treated by physiotherapy, showing cognitive impairment, in the Valencia Community. Protection study in older people (EPACV). BMC Neurol. 2012 Oct 5;12:118. doi: 10.1186/1471-2377-12-118.

  PMID: 23039063 RESULT

• Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen 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(14):609-11. doi: 10.1016/j.medcli.2011.10.004. Epub 2011 Dec 6. Spanish.

  PMID: 22153783 RESULT

• Oliva-Moreno J, Pena-Longobardo LM, Mar J, Masjuan J, Soulard S, Gonzalez-Rojas N, Becerra V, Casado MA, Torres C, Yebenes M, Quintana M, Alvarez-Sabin J; CONOCES Investigators Group. Determinants of Informal Care, Burden, and Risk of Burnout in Caregivers of Stroke Survivors: The CONOCES Study. Stroke. 2018 Jan;49(1):140-146. doi: 10.1161/STROKEAHA.117.017575. Epub 2017 Nov 28.

  PMID: 29183953 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• JOSE L CLUA-ESPUNY, PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  STUDY DIRECTOR

• CONCEPCION CARRATALA-MUNUERA, PhD

  Universidad Miguel Hernandez de Elche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 1, 2018
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: December 31, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

ES (1)