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SCORE: Proces en uitkomsten van revalidatie na een beroerte


- candidate number15707
- NTR NumberNTR4293
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2013
- Secondary IDsABR46531 
- Public TitleSCORE: Proces en uitkomsten van revalidatie na een beroerte
- Scientific TitleSCORE: Stroke Cohort Outcome REhabilitation
- ACRONYMSCORE
- hypothesis1. Differences in usual care between rehabilitation centers lead to differences in functioning, patient satisfaction and costs
2. Community participation depends on various person- and disease-related variables.
- Healt Condition(s) or Problem(s) studiedStroke, Rehabilitation
- Inclusion criteria-First ever stroke
-Time since stroke < 6 months
-Age 18 years or older
-Written informed consent
- Exclusion criteria- Severe psychiatric condition or premorbid dementia
- Impossible to communicatie in the Dutch language
- Concurrent acquired brain injury (traumatic or non-traumatic) or pre-existent brain disease that was diagnosed before the onset of stroke.
- Drug or alcohol abuse
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-sep-2018
- Target number of participants432
- InterventionsNone
- Primary outcomeFunctioning
Community participation
Quality of life
Patient satisfaction
Structure of rehabilitation
Process of rehabilitation
Costs of rehabilitation
- Secondary outcomeIllness perceptions
Self-management
Depression
Fatigue
Pain
Unmet Needs
Expectations and fulfilment of goals
Caregiver satisfaction
Caregiver burden
- TimepointsBaseline (upon entrance at rehabilitation as an in- or outpatient), discharge (if applicable), and 3, 6, 12, 18, 24, and 30 months after baseline.
- Trial web sitehttps://rrc.nl/expert/onderzoek/score/
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Felicie Vree, van
- CONTACT for SCIENTIFIC QUERIESDr. Iris Groeneveld
- Sponsor/Initiator Sophia Rehabilitation Centre, Leiden University Medical Center (LUMC), Rijnlands Revalidatie Centrum
- Funding
(Source(s) of Monetary or Material Support)
Rijnlands Revalidatie Centrum and Sophia Revalidatie, Stichting Kwaliteitsgelden Medisch Specialisten
- PublicationsN/A
- Brief summarybackground: Stroke leads to substantial disability in the majority of patients and imposes a considerable financial burden to society. Rehabilitation is an effective management strategy, however there is variation between centres with respect to its structure and process. Treatment diversity and outcomes, patient perspectives and costs of rehabilitative treatment are understudied, as well as the predictors of long-term participation in society. Aims: 1. To describe: a) physical and cognitive functioning, quality of life and participation of stroke patients at short and long term; b) structure and process of in- and outpatient stroke rehabilitation; c) patient perspectives on illness and treatment; d) caregiver perspectives on caregiving and treatment; e) rehabilitation-related costs. 2) To explore differences between two rehabilitation centres in a) structure and process of treatment; b) patientsí satisfaction; c) physical functioning; and d) costs of treatment; 3) To determine which factors are associated with community participation of stroke survivors on the long term.
Study design: This project has a multicentre, observational, longitudinal design, and includes stroke patients in the Rijnlands Rehabilitation Center Leiden and Sophia Rehabilitation The Hague. The duration of the study is 4.5 years, with the inclusion period being 2 years. Study population: Patients admitted to inpatient or outpatient rehabilitation for a first ever stroke, time since stroke not longer than 6 months, age 18 years or older, and having provided written informed consent. We aim to include a minimum of 432 patients within the initial recruitment period. Main study parameters: Assessments will be done at baseline, discharge (if applicable) and at 3, 6, 12, 18, 24 and 30 months. The following outcomes will be assessed: 1) Functioning (Barthel Index, 2 SIS-scales); community participation (CIQ), quality of life (SAQOL-39g, EQ-5D), depression (HADS), fatigue (FSS), pain (VAS); 2) Structure (rehabilitation centerís protocols), and process (e.g. type, frequency, duration of treatment) of rehabilitation (rehabilitation centerís administrative database); 3) patientsí satisfaction with stroke care (SASC), illness perceptions (IPQ-R), longer term unmet needs (LUNS), self-management (TBD); 4) caregiver strain (CSI) and caregiver satisfaction (C-SASC); 5) Costs of rehabilitation (rehabilitation centerís administrative database), health care usage and absenteeism (self-developed questionnaires). At baseline, sociodemographic characteristics, stroke characteristics (NIHSS), comorbidities (based on POLS), and frailty (GFI) will be registered.
- Main changes (audit trail)28-okt-2017 -IK:
Sponsor 'Rijnland Hospital' replaced by 'Rijnlands Revalidatie Centrum'

Funding source: 'Stichting Kwaliteitsgelden Medisch Specialisten' was added
- RECORD17-nov-2013 - 28-okt-2017


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