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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group - Patients | No Intervention | Usual care and rehabilitation. | |
| OT intervention group - Patients | Experimental | Patients assigned to the experimental group are included in an early occupational therapy intervention program. |
|
| Control group - Caregivers | No Intervention | Caregivers of patients who receive usual care and rehabilitation. | |
| OT intervention group - Caregivers | Experimental | Caregivers of the patients that are in the experimental group and are included in an early occupational therapy intervention program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Occupational Therapy intervention | Other | four-week OT intervention program for 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life | Assessed with Stroke and aphasia quality of life scale-39 (SAQOL-39). Unit of measure will be the result of this assessment. Final score goes from 0 to 195 (higher score, better outcome). | Before intervention (baseline) and after intervention (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Sensory-motor Skills | Assessed with Fugl Meyer Assessment (FMA). Unit of measure will be the result of this assessment. Total score is 0 to 126 (the higher score, the better upper limb sensory-motor skills). | Before intervention (baseline) and after intervention (3 months) |
| Patient Perceptual-cognitive Skills |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Burden. | Caregiver burden was evaluated with Caregiver Burden Scale (CBS). The Caregiver Burden Scale (CBS) is a 22-item scale that assesses the burden subjectively experienced by caregivers.The total score range is 0 to 88, where the higher the score, the more severe the burden: 0-21 no or mild burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and ≥61 severe burden. | Before intervention (baseline) and after intervention (3 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PATRICIA GARCIA PEREZ | University of Malaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39159190 | Derived | Garcia-Perez P, Rodriguez-Martinez MC, Gallardo-Tur A, Blanco-Reina E, de la Cruz-Cosme C, Lara JP. Early Occupational Therapy Intervention post-stroke (EOTIPS): A randomized controlled trial. PLoS One. 2024 Aug 19;19(8):e0308800. doi: 10.1371/journal.pone.0308800. eCollection 2024. |
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Out of all the patients that were asked for enrollment, only 55 had a relative or friend as a caregiver and agreed to cooperate with the research.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Control Group | Patients received usual care by ward and rehabilitation staff. |
| FG001 | Patients Experimental Group: EOTIPS Intervention. | Patients assigned to the experimental group are included in an early occupational therapy intervention program. Early Occupational Therapy intervention (EOTIPS): four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving patient quality of life and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. |
| FG002 | Caregivers Control Group | Caregivers of patients who received usual care by ward and rehabilitation staff. |
| FG003 | Caregivers Experimental Group | Caregivers of patients assigned to the experimental group who are included in an early occupational therapy intervention program. Early Occupational Therapy intervention (EOTIPS): four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving patient quality of life and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The sample size "n" was calculated to represent the total population of patients who suffer a stroke and are admitted to the Virgen de la Victoria University Hospital in Malaga, and who, after the neurological intervention, are left with sequelae susceptible to rehabilitation, but who do not acquire a place as inmates in the rehabilitation unit (a total of 800 stroke admissions to the Hospital are estimated per year).
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group - Patients | Usual care provided by hospital/community staff. |
| BG001 | EOTIPS (OT Intervention) - Patients | Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program. Early Occupational Therapy intervention: four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving quality of life and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Quality of Life | Assessed with Stroke and aphasia quality of life scale-39 (SAQOL-39). Unit of measure will be the result of this assessment. Final score goes from 0 to 195 (higher score, better outcome). | Patients that enrolled EOTIPS program were assessed with SAQOL-39 in order to define wether their quality of life has improved, comparing to a control group. | Posted | Mean | Standard Deviation | score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
18 months
There were not adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group - Patients | Participants that enroll control group received usual/standard care and rehabilitation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garcia-perez, Patricia | University of Malaga | +34 675447206 | terapiaocupacional.patricia@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2023 | Aug 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Assessed with Montreal Cognitive Assessment (MoCA). MoCA has been proposed as a screening tool that promises good sensitivity to deficits that result from stroke and vascular cognitive impairment. Unit of measure will be the result of this assessment.The final score goes from 0 to 30 (higher score, better outcome). |
| Before intervention (baseline) and after intervention (3 months) |
| Patient Communication Skills | Assessed with Communicative Activity Log (CAL). Scale that allows obtaining information on communication skills in activities of daily life referring to comprehensive and expressive aspects of language. Unit of measure will be the result of this assessment. Final score goes from 0 to 190 (higher score, better outcome). | Before intervention (baseline) and after intervention (3 months) |
| Depression of the Patient | Assessed with Beck Depression Inventory (BDI-2). It is one of the most commonly used instruments to measure the severity of depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 63 (lower score, better outcome). | Before intervention (baseline) and after intervention (3 months) |
| Patient Mobility | Assessed with Time up and go (TUG). The TUG assesses basic mobility, timing the time required for a person to get up from a standardized chair, walk a distance of three meters, turn, return to the chair, and sit down again. Unit of measure will be the result of this assessment, which is the time in seconds. Shorter time means better performance. | Before intervention (baseline) and after intervention (3 months) |
| Patient Functional Balance | Assessed with Berg Balance Scale (BBS) which evaluates assesses functional balance. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (higher score, better outcome). | Before intervention (baseline) and after intervention (3 months) |
| Anxiety of the Patient | Assessed with Hamilton anxiety scale. This scale assesses the severity of anxiety globally in patients who meet criteria for anxiety or depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (lower score, better outcome). | Before intervention (baseline) and after intervention (3 months) |
| Patient Functional Independence Assessed With Barthel Index | The main unit of measure is the result of Barthel Index (from 0 to 100), 0 meaning disability and 100 meaning independence, therefore, higher score, better outcome. The main goal of this research is to assess independence of the patient and support needs in activities of daily living. The Barthel index measures the extent to which someone can function independently during basic activities of daily living. | Before intervention (baseline) and after intervention (3 months) |
| Patient Functional Independence Assessed With Stroke Impact Scale-16 | Unit of measure will be the result of this assessment. The score goes from 16 to 80, 80 meaning independence (higher score, better outcome). The usefulness of this scale is similar to that of the Barthel Index, although it is more sensitive than the latter to discriminate between patients with mild disabilities. | Before intervention (baseline) and after intervention (3 months) |
| Patient Disability Assessed With Modified Rankin Scale (mRs) | The mRS is used to describe disability in general. Unit of measure will be the result of this assessment. The score goes from 0 to 6, 0 meaning no symptoms and 6 meaning death (higher score, worse outcome). | Before intervention (baseline) and after intervention (3 months) |
| Caregivers Coping Strategies. | The caregivers coping strategies were evaluated with the Coping Strategies Inventory (CSI), that was adapted to 40 items. The scale measures individual coping strategies that are broadly classified into two basic approaches to managing stressful situations: coping activities that involve the individual in the stressful situation (engagement strategies) and coping activities that disengage the individual (disengagement strategies). Total subscales score range are: disengagement strategies 0 to 60 and engagement strategies 0 to 60. The higher the score, the more strategies of that type they have. | Before intervention (baseline) and after intervention (3 months) |
| BG002 | Control Group - Caregivers | Caregivers of patients who received usual care by ward and rehabilitation staff. |
| BG003 | EOTIPS (OT Intervention) - Caregivers | Caregivers of patients assigned to the experimental group who are included in an early occupational therapy intervention program. Early Occupational Therapy intervention (EOTIPS): four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving patient quality of life and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Native language: spanish | Count of Participants | Participants |
|
| Marital status | Caregivers were not assessed for this measure. | Count of Participants | Participants |
|
| Education | Caregivers were not assessed for this measure. | Count of Participants | Participants |
|
| Employment status | Caregivers were not assessed for this measure. | Count of Participants | Participants |
|
|
|
|
| Secondary | Patient's Sensory-motor Skills | Assessed with Fugl Meyer Assessment (FMA). Unit of measure will be the result of this assessment. Total score is 0 to 126 (the higher score, the better upper limb sensory-motor skills). | All participants were assessed with Fugl-Meyer sensory motor assessment (FMA) in order to define wether EOTIPS program induced an improvement in the motor upper limb functions compared to the control group. | Posted | Mean | Standard Deviation | Score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Perceptual-cognitive Skills | Assessed with Montreal Cognitive Assessment (MoCA). MoCA has been proposed as a screening tool that promises good sensitivity to deficits that result from stroke and vascular cognitive impairment. Unit of measure will be the result of this assessment.The final score goes from 0 to 30 (higher score, better outcome). | Cognitive impairment was assessed with Montreal Cognitive Assessment (MoCA) to define if cognition has improved in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | Score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Communication Skills | Assessed with Communicative Activity Log (CAL). Scale that allows obtaining information on communication skills in activities of daily life referring to comprehensive and expressive aspects of language. Unit of measure will be the result of this assessment. Final score goes from 0 to 190 (higher score, better outcome). | Communication was assessed with Communicative Activity Log (CAL) to define if the communication skills were better in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | Score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Depression of the Patient | Assessed with Beck Depression Inventory (BDI-2). It is one of the most commonly used instruments to measure the severity of depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 63 (lower score, better outcome). | Depression was assessed with Beck Depression Inventory (BDI-2) to define if the level of depression was lower in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Mobility | Assessed with Time up and go (TUG). The TUG assesses basic mobility, timing the time required for a person to get up from a standardized chair, walk a distance of three meters, turn, return to the chair, and sit down again. Unit of measure will be the result of this assessment, which is the time in seconds. Shorter time means better performance. | Basic mobility was assessed with Timed Up and Go (TUG)) to define if it improved more in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | seconds | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Functional Balance | Assessed with Berg Balance Scale (BBS) which evaluates assesses functional balance. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (higher score, better outcome). | Functional balance was assessed with Berg Balance Scale (BBS) to define if it improved more in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Anxiety of the Patient | Assessed with Hamilton anxiety scale. This scale assesses the severity of anxiety globally in patients who meet criteria for anxiety or depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (lower score, better outcome). | Anxiety of the patient was assessed with Hamilton anxiety scale to define if it improved more in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Functional Independence Assessed With Barthel Index | The main unit of measure is the result of Barthel Index (from 0 to 100), 0 meaning disability and 100 meaning independence, therefore, higher score, better outcome. The main goal of this research is to assess independence of the patient and support needs in activities of daily living. The Barthel index measures the extent to which someone can function independently during basic activities of daily living. | The functional independence was assessed with Barthel Index to define if it improved more in the EOTIPS group compared to the control group. | Posted | Mean | Standard Error | score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Functional Independence Assessed With Stroke Impact Scale-16 | Unit of measure will be the result of this assessment. The score goes from 16 to 80, 80 meaning independence (higher score, better outcome). The usefulness of this scale is similar to that of the Barthel Index, although it is more sensitive than the latter to discriminate between patients with mild disabilities. | The functional independence was assessed with SIS-16 to define if it improved more in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Secondary | Patient Disability Assessed With Modified Rankin Scale (mRs) | The mRS is used to describe disability in general. Unit of measure will be the result of this assessment. The score goes from 0 to 6, 0 meaning no symptoms and 6 meaning death (higher score, worse outcome). | The patient general disability was assessed with modified Rankin scale to define if it improved more in the EOTIPS group compared to the control group. | Posted | Mean | Standard Deviation | Score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Other Pre-specified | Caregiver Burden. | Caregiver burden was evaluated with Caregiver Burden Scale (CBS). The Caregiver Burden Scale (CBS) is a 22-item scale that assesses the burden subjectively experienced by caregivers.The total score range is 0 to 88, where the higher the score, the more severe the burden: 0-21 no or mild burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and ≥61 severe burden. | The caregivers that wanted to participate in the study were evaluated. | Posted | Mean | Standard Deviation | Score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| Other Pre-specified | Caregivers Coping Strategies. | The caregivers coping strategies were evaluated with the Coping Strategies Inventory (CSI), that was adapted to 40 items. The scale measures individual coping strategies that are broadly classified into two basic approaches to managing stressful situations: coping activities that involve the individual in the stressful situation (engagement strategies) and coping activities that disengage the individual (disengagement strategies). Total subscales score range are: disengagement strategies 0 to 60 and engagement strategies 0 to 60. The higher the score, the more strategies of that type they have. | The caregivers that were involved in the recovery of the patients were included in the study and evaluated. | Posted | Mean | Standard Deviation | Score on a scale | Before intervention (baseline) and after intervention (3 months) |
|
|
|
|
| 1 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | OT Intervention (EOTIPS) - Patients | Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program. Early Occupational Therapy intervention: 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. | 1 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Control Group - Caregivers | Caregivers of the participants in the control group. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | OT Intervention (EOTIPS) - Caregivers | Caregivers of the participants in the experimental group. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Widowed |
|
| Married/living with partner |
|
| Primary school |
|
| High school |
|
| University |
|
| Retired |
|
| Temporary disability |
|
| Other activities |
|
| Engagement strategies - AFTER |
|
| Disengagement strategies - AFTER |
|
| 0.496 |
| Superiority |