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Screening and patient-tailored care for Emotional and COgnitive problems in patients discharged home after ischemic stroke (ECO-stroke)

Screening and patient-tailored care for Emotional and COgnitive problems in patients discharged home after ischemic stroke (ECO-stroke)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28988
Enrollment
516
Registered
2018-09-25
Start date
2019-07-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke, after-care, societal participation, quality of life, cost-benefit analysis, cognition, emotion beroerte, herseninfarct, CVA-nazorg, nazorg, (maatschappelijke) participatie, kosteneffectitiveit, cognitie, emotie

Interventions

A short, individualized, semi-structured consultation, focused on emotional and cognitive problems executed by a nurse (either a specialized nurse, nurse specialist, nurse practitioner or physician as
2. a structured screening for restrictions in societal participation by the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-P Restriction
3. self-management support: a) providing timely and individualized active oral and written information about stroke and its possible emotional and cognitive consequences, b) measuring self-efficacy by
4. a guideline for referall to rehabilitation services based on the results

Sponsors

OLVG Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - clinical diagnosis of 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 rehabilitation or follow-up care at the physiatry outpatient clinics.

Exclusion criteria

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; - unable to understand questionnaires due to insufficient Dutch language proficiency or aphasia based on clinical judgement; ; - legally incompetent adults; - no informed consent.

Design outcomes

Primary

MeasureTime frame
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 (USER-P Restriction) at 1 year.

Secondary

MeasureTime frame
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 (Six-Dimensional EuroQol (EQ-6D-5L)), patient-reported global health (PROMIS Global-10), physical disability (modified Rankin Scale (mRS)) and self-efficacy (General Self-Efficacy Scale (GSES)) at 1 year. Data will be collected at six weeks (T1), three months (T2) and 12 months (T3) after stroke. Besides, patient satisfaction will be measured by a customized version of the SASC-19 and will be completed at 3 months. 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). 3. A process evaluation by a mixed methods study will be conducted parallel to the randomized controlled trial to establish the feasibility of the intervention by assessing performance according to protocol, attendance and adherence, and the opinion of patients, and professionals about the intervention. In this prospective mixed methods study, data will be gathered using questionnaires for patients, registration forms for professionals and by carrying out semi-structured interviews with patients and professionals. All materials will be developed specifically for this study and intervention.

Contacts

Public ContactJ. Slenders

OLVG Amsterdam

j.p.l.slenders@olvg.nl0205108802

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)