Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835363
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2021-03-25
Brief Title:
Early Occupational Therapy Intervention in the Hospital Discharge After Stroke
Sponsor:
University of Malaga
Organization:
University of Malaga
Study Overview
Official Title:
Early Occupational Therapy Intervention in the Hospital Discharge After Stroke Study Protocol for a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The general objective of this study is to determine if an early occupational therapy intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the 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 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 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 intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the 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 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 to the caregiver about specific care and neurorehabilitation Primary outcome functional independence of the patient and support needs in activities of daily living Secondary outcomes improvement in sensory-motor skills perceptual-cognitive skills communication skills quality of life and levels of anxiety and depression of the patient as well as caregiver coping strategies and burden The final results are evaluated three months after discharge At the same time data are collected on readmissions to the hospital mortality return to work and return to driving as well as an economic health analysis Interviews and evaluations will be conducted with all patients and caregivers before discharge and three months after
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 Málaga Oeste Spain being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation
General and specific objectives The general objective of this study is to determine if an early occupational therapy intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the 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 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 to the caregiver about specific care and neurorehabilitation Primary outcome functional independence of the patient and support needs in activities of daily living Secondary outcomes improvement in sensory-motor skills perceptual-cognitive skills communication skills quality of life and levels of anxiety and depression of the patient as well as caregiver coping strategies and burden The final results are evaluated three months after discharge At the same time data are collected on readmissions to the hospital mortality return to work and return to driving as well as an economic health analysis Interviews and evaluations will be conducted with all patients and caregivers before discharge and three months after
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 Málaga Oeste Spain being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None