Clinical trial NCT05566782: Cross-sectoral Rehabilitation After Stroke (CRES)
Official title: Cross-sectoral Rehabilitation After Stroke (CRES)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Neurological Rehabilitation
Patient Involvement
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited by the PhD-student Gabriel Tafdrup Notkin (GTN) in collaboration with the Department of Neurology. Potential participants will be approached during admission at the Department of Neurology, NOH.

Potential participants will be informed about the study orally and in writing. Patients will be informed that participation is voluntary and that they can withdraw from the study at any time. There will be an opportunity for reflection time and for the patient to discuss the decision to participate with relatives or caregivers. If the patient wishes to participate in the study, written consent will be obtained in the form of a completed consent form from the patient and relatives.

Brief summary: Prospective cohort study during post stroke rehabilitation in hospital and municipality. Participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews.

Detailed description: During and after hospitalization, patients with stroke are subjected to early rehabilitation starting at the hospital stay and continuing after discharge to a municipality. However, the continuity and adherence across sectors is challenged by different locations for the rehabilitation and time gaps from discharge to start in municipality.

This project focuses on the physical activity of patients with stroke measured with 3D accelerometry, the physical performance of the patients measured using the 30 second Chair Stand Test, balance measured with Bergs Balance Scale and health-related quality of life (HRQoL) measured with the 5-level version of European Quality of Life (EQ5D-5L). Furthermore, the patient perspectives and experiences with the rehabilitation plans are explored in semi-structured interviews at the end of the project.

The municipalities in Nordsjælland have been informed regarding the project and all their approvals have been collected prior to expected start in fall 2022. The heads of rehabilitation in the municipalities have approved participation in the research project with regards to follow-up of patients. The municipalities will support the data collection process with a therapist from each municipality working with quality control of the rehabilitation.

Eligibility criteria: Inclusion Criteria:

* 18 years of age;
* Hospitalized at Nordsjællands Hospital (NOH) with acute stroke;
* Discharged from the Department of Neurology NOH with a general rehabilitation plan to one of the eight surrounding municipalities (Hillerød, Allerød, Gribskov, Helsingør, Hørsholm, Halsnæs, Frederikssund Fredensborg);
* able to give written informed consent;

Exclusion Criteria:

* Poor Danish language skill;
* Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;

Primary outcomes:
measure: Physical activity measured by step counts and intensity minutes during the day (raw acceleration per time cycle)
timeFrame: 10-14 days from hospital discharge til start of rehabilitation in municipality
measure: Change in physical function (30 second chair stand test)
timeFrame: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
measure: Change in balance (Bergs Balance Scale)
timeFrame: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
measure: Change in Health Related Quality of Life (EQ5D-5L)
timeFrame: Measurement at the start of rehabilitation (day 1) and at the anticipated end of rehabilitation (day 95)
Secondary outcomes:
measure: Severity of stroke (Scandinavian Stroke Scale)
timeFrame: within 24 hours of admission
measure: Rate of dependence post stroke evaluated by modified Rankin Scale (mRS)
timeFrame: Measurement at the discharge from hospital stay (anticipated day 4)
measure: Demographic variables
timeFrame: Measurement at the start of rehabilitation (anticipated day 1 of hospital admission)
Other outcomes:
Locations:
city: Hillerod
country: Denmark
facility: Nordsjællands Hospital Department of Neurology
Study officials:
affiliation: Physiotherapist, Department of Neurology
name: Gabriel T Notkin, MSc.PT.
role: PRINCIPAL_INVESTIGATOR
References: