|- candidate number||29579|
|- NTR Number||NTR7504|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-sep-2018|
|- Secondary IDs||843004122 ZonMw|
|- Public Title||ECO-stroke|
|- Scientific Title||Emotional and Cognitive screening in patients discharged home after ischemic stroke |
|- hypothesis||Patients with good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. Nevertheless, a significant amount of these patients has cognitive and emotional complaints resulting in lower quality of life and decreased social participation. Therefore, screening and education about cognitive and emotional complaints for patients after ischemic stroke might positively influence social participation, cognitive and emotional complaints and the quality of life.|
|- Healt Condition(s) or Problem(s) studied||Ischemic stroke, Cognition, Quality of life, Stroke, Stroke, Aftercare, Cost-effectiveness |
|- Inclusion criteria||- ischemic stroke as diagnosed by a neurologist after anamnesis, neurological examination and CT-brain or MRI-brain |
- signs and symptoms resolve sufficiently to discharge subjects to their homes without the need for inpatient or outpatient rehabilitation.
|- Exclusion criteria||- age below 18 years|
- any serious comorbidity that 1) presumably interferes with the study outcomes (e.g. a psychiatric disorder wherefore supervision of an psychiatrist is needed), 2) has a progressive course (e.g. cancer, multiple sclerosis, and a diagnosis of mild cognitive impairment or dementia) or 3) has a life expectancy of less than 6 months
- transient ischemic attack defined as symptoms of a stroke that last less than 24 hours and are not accompanied with ischemic lesions in the corresponding vascular territory on CT-scan or MRI.
- hemorrhagic stroke
- insufficient Dutch language proficiency to participate and understand questionnaires
- legally incompetent adults
- no informed consent
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2019|
|- planned closingdate||31-dec-2022|
|- Target number of participants||502|
|- Interventions||A short, individualized, semi-structured consultation, focused on cognitive and emotional problems executed by a specalized nurse at the outpatient clinics. The consultation will take about 1 hour.
The main elements of the protocol are:
1. Systematic screening for cognitive and emotional problems using sensitive instruments
2. Providing individualized information and education about stroke, its consequences and resumption of prior activities, with the cognitive and emotional changes and challenges
3. Promotion of self-management strategies
4. Referral to rehabilitation services if assumed necessary after the consultation by the nurse in cooperation with a physiatrist.
|- Primary outcome||The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation Restriction (USER-P Restriction) at 1 year.|
|- Secondary outcome||1. The following secondary outcome measures for clinical effectiveness will be used: cognitive complaints (Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24)), depression and anxiety (Hospital Anxiety and Depression Scale (HADS)), quality of life (Five-Dimensional EuroQol (EQ-5D-5L)), patient-reported global health (PROMIS Global-10) and physical disability (modified Rankin Scale (mRS)) at 1 year. All questionnaires will be completed at 6 weeks (T1), 3 months (T2) and 1 year after the ischemic stroke (T3).
2. With regard to the economic evaluation, the quality of life will be measured with the EQ-5D-5L and the use of care and health-related costs will be assessed with the Medical Consumption Questionnaire (MCQ) and the Productivity Cost Questionnaire (PCQ). Data will be collected at 6 weeks, 3 months (T2) and 12 months (T3).
|- Timepoints||T1 baseline - index event|
T1 6 weeks: follow-up moment and intervention for the intervention group
T2 3 months: follow-up moment
T3 12 months: follow-up moment
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| J. Slenders|
|- CONTACT for SCIENTIFIC QUERIES||Dr. V.I.H. Kwa|
|- Sponsor/Initiator ||OLVG|
(Source(s) of Monetary or Material Support)
|- Brief summary||A multicenter, open-label, cluster randomized controlled trial will be performed in order to examine the effect of an intervention focused on screening and care for cognitive and emotional complaints as compared to usual care in subjects with ischemic stroke who are discharged home without inpatient or outpatient rehabilitation care. Centers will be randomized (1:1) to the protocol group or the usual care group. Subjects (>18 years old) with a diagnosis of ischemic stroke that resolves sufficiently to discharge subjects to their homes without the need for inpatient or outpatient rehabilitation treatment will be included. The intervention encompasses a short, individualized, semi-structured consultation, focused on cognitive and emotional problems. This consultation 1) includes systematic screening for cognitive and emotional problems using sensitive instruments, 2) provides individualized information and education about stroke, its consequences and resumption of prior activities, with the cognitive and emotional changes and challenges, 3) promotes self-management strategies and 4) includes referral to rehabilitation services if assumed necessary. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation Restriction (USER-P Restriction) at 1 year.|
|- Main changes (audit trail)||Non-WMO Study|
|- RECORD||25-sep-2018 - 30-nov-2018|