Clinical trial NCT04835363: Early Occupational Therapy Intervention in the Hospital Discharge After Stroke
Official title: Early Occupational Therapy Intervention in the Hospital Discharge After Stroke: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: patient discharge
occupational therapy
rehabilitation
caregivers
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life and functional independence of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation.

Detailed description: Background: Stroke is the leading cause of acquired disability in adults, being a cerebrovascular disease of great impact in health and social terms, due not only to its prevalence and incidence, but to the great repercussion in terms of dependence and its consequent impact on the life of the patient and family.

General and specific objectives: The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge about specific care and neurorehabilitation. Primary outcome: quality of life and functional independence. Secondary outcomes: improvement in sensory-motor skills, perceptual-cognitive skills, communication skills, levels of anxiety and depression of the patient, as well as caregivers' burden and coping strategies. The final results are evaluated three months after discharge.

Study Design: This is a prospective, randomized, controlled clinical trial. The sample size is made up of 60 patients who will be divided into two groups: the control group, with 30 users, and the experimental group, with another 30 users. The sample will be made up of patients who have suffered a stroke and have been discharged from the neurology service of a second-level hospital in West Malaga (Spain), being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department. Patients assigned to the experimental group and their caregivers are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stroke with single or multiple vascular lesions that have occurred in the same time period, demonstrated by neuroimaging tests (CT or MRI).
* 18 years of age or older.
* Patient must live a maximum of 30 minutes away from the hospital center.
* Must present \> 2 or \<26 points on the National Institute of Health scale (NIHSS) and 30-100 points on the Barthel Index (BI) on the second day of the stroke (with BI 100, the patient can be included if the Montreal Cognitive Assessment is \<26).
* Patient must present some motor deficit that makes it difficult to carry out his ADL.
* Inclusion in the study occurs prior to hospital discharge.

Exclusion Criteria:

* NIHSS\> 26 and BI \<30.
* Life expectancy \<1 year.
* Previous stroke, dementia or other types of illnesses associated with dementia and other neurological, psychiatric or medical illnesses (for example, severe epilepsy, head trauma, schizophrenia, COPD, severe or unstable heart disease, sleep apnea) that could alter cognitive function.
* Moderate-severe aphasia.
* Does not understand Spanish or English.

Primary outcomes:
measure: Patient Quality of Life
timeFrame: Before intervention (baseline) and after intervention (3 months)
Secondary outcomes:
measure: Patient's Sensory-motor Skills
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Perceptual-cognitive Skills
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Communication Skills
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Depression of the Patient
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Mobility
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Functional Balance
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Anxiety of the Patient
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Functional Independence Assessed With Barthel Index
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Functional Independence Assessed With Stroke Impact Scale-16
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Patient Disability Assessed With Modified Rankin Scale (mRs)
timeFrame: Before intervention (baseline) and after intervention (3 months)
Other outcomes:
measure: Caregiver Burden.
timeFrame: Before intervention (baseline) and after intervention (3 months)
measure: Caregivers Coping Strategies.
timeFrame: Before intervention (baseline) and after intervention (3 months)
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: University of Malaga
name: PATRICIA GARCIA PEREZ
role: PRINCIPAL_INVESTIGATOR
References: