Trial Outcomes & Findings for Early Occupational Therapy Intervention in the Hospital Discharge After Stroke (NCT NCT04835363)
NCT ID: NCT04835363
Last Updated: 2025-02-10
Results Overview
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).
COMPLETED
NA
117 participants
Before intervention (baseline) and after intervention (3 months)
2025-02-10
Participant Flow
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.
Participant milestones
| Measure |
Patients Control Group
Patients received usual care by ward and rehabilitation staff.
|
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.
|
Caregivers Control Group
Caregivers of patients who received usual care by ward and rehabilitation staff.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
27
|
28
|
|
Overall Study
COMPLETED
|
30
|
30
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caregivers were not assessed for this measure.
Baseline characteristics by cohort
| Measure |
Control Group - Patients
n=31 Participants
Usual care provided by hospital/community staff.
|
EOTIPS (OT Intervention) - Patients
n=31 Participants
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.
|
Control Group - Caregivers
n=27 Participants
Caregivers of patients who received usual care by ward and rehabilitation staff.
|
EOTIPS (OT Intervention) - Caregivers
n=28 Participants
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.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=117 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=31 Participants
|
18 Participants
n=31 Participants
|
24 Participants
n=27 Participants
|
23 Participants
n=28 Participants
|
81 Participants
n=117 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=31 Participants
|
13 Participants
n=31 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=28 Participants
|
36 Participants
n=117 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 10.6 • n=31 Participants
|
68.5 years
STANDARD_DEVIATION 10.7 • n=31 Participants
|
60 years
STANDARD_DEVIATION 22.3 • n=27 Participants
|
61.2 years
STANDARD_DEVIATION 19.8 • n=28 Participants
|
67.5 years
STANDARD_DEVIATION 10.6 • n=117 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=31 Participants
|
12 Participants
n=31 Participants
|
15 Participants
n=27 Participants
|
20 Participants
n=28 Participants
|
62 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=31 Participants
|
19 Participants
n=31 Participants
|
12 Participants
n=27 Participants
|
8 Participants
n=28 Participants
|
55 Participants
n=117 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=31 Participants
|
25 Participants
n=31 Participants
|
25 Participants
n=27 Participants
|
23 Participants
n=28 Participants
|
101 Participants
n=117 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=31 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=28 Participants
|
16 Participants
n=117 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=117 Participants
|
|
Region of Enrollment
Spain
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
27 participants
n=27 Participants
|
28 participants
n=28 Participants
|
117 participants
n=117 Participants
|
|
Native language: spanish
|
29 Participants
n=31 Participants
|
29 Participants
n=31 Participants
|
26 Participants
n=27 Participants
|
26 Participants
n=28 Participants
|
110 Participants
n=117 Participants
|
|
Marital status
Single
|
2 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
3 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
5 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Marital status
Divorced
|
2 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
2 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
4 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Marital status
Widowed
|
6 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
6 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
12 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Marital status
Married/living with partner
|
21 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
20 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
41 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Education
No studies
|
1 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
1 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
2 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Education
Reads/writes
|
8 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
12 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
20 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Education
Primary school
|
15 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
9 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
24 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Education
High school
|
5 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
3 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
8 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Education
University
|
2 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
6 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
8 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Employment status
Househusband/housewife
|
1 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
4 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
5 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Employment status
Unemployed
|
2 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
1 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
3 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Employment status
Retired
|
20 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
18 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
38 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Employment status
Temporary disability
|
8 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
7 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
15 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
|
Employment status
Other activities
|
0 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
1 Participants
n=31 Participants • Caregivers were not assessed for this measure.
|
—
|
—
|
1 Participants
n=62 Participants • Caregivers were not assessed for this measure.
|
PRIMARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Quality of Life
After intervention (3 months)
|
3.41 score on a scale
Standard Deviation 0.69
|
3.91 score on a scale
Standard Deviation 0.70
|
|
Patient Quality of Life
Before intervention (baseline)
|
2.51 score on a scale
Standard Deviation 0.75
|
2.67 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient's Sensory-motor Skills
After intervention (3 months)
|
111.10 Score on a scale
Standard Deviation 17.6
|
117 Score on a scale
Standard Deviation 12.6
|
|
Patient's Sensory-motor Skills
Before intervention (baseline).
|
99.80 Score on a scale
Standard Deviation 22.60
|
102.00 Score on a scale
Standard Deviation 18.90
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: Cognitive impairment was assessed with Montreal Cognitive Assessment (MoCA) to define if cognition has improved in the EOTIPS group compared to the control group.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Perceptual-cognitive Skills
After intervention (3 months).
|
20.1 Score on a scale
Standard Deviation 7.06
|
24.8 Score on a scale
Standard Deviation 6.58
|
|
Patient Perceptual-cognitive Skills
Before intervention (baseline).
|
16.6 Score on a scale
Standard Deviation 7.33
|
18.6 Score on a scale
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Communication Skills
After intervention (3 months).
|
116 Score on a scale
Standard Deviation 31.1
|
137 Score on a scale
Standard Deviation 24.2
|
|
Patient Communication Skills
Before intervention (baseline).
|
109.00 Score on a scale
Standard Deviation 37.00
|
122.00 Score on a scale
Standard Deviation 27.30
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Depression of the Patient
After intervention (3 months).
|
15.3 score on a scale
Standard Deviation 10.48
|
8.4 score on a scale
Standard Deviation 8.88
|
|
Depression of the Patient
Before intervention (baseline).
|
13.60 score on a scale
Standard Deviation 9.76
|
11.23 score on a scale
Standard Deviation 9.11
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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.
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Mobility
After intervention (3 months).
|
12.4 seconds
Standard Deviation 4.83
|
14.3 seconds
Standard Deviation 12.8
|
|
Patient Mobility
Before intervention (baseline).
|
28.40 seconds
Standard Deviation 17.68
|
29.00 seconds
Standard Deviation 12.90
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: Functional balance was assessed with Berg Balance Scale (BBS) to define if it improved more in the EOTIPS group compared to the control group.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Functional Balance
After intervention (3 months).
|
45.3 score on a scale
Standard Deviation 11.7
|
47 score on a scale
Standard Deviation 11.1
|
|
Patient Functional Balance
Before intervention (baseline).
|
22.70 score on a scale
Standard Deviation 17.90
|
27.60 score on a scale
Standard Deviation 14.60
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Anxiety of the Patient
Before intervention (baseline).
|
11.50 score on a scale
Standard Deviation 10.88
|
8.47 score on a scale
Standard Deviation 10.96
|
|
Anxiety of the Patient
After intervention (3 months).
|
11.3 score on a scale
Standard Deviation 9.4
|
5.5 score on a scale
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: The functional independence was assessed with Barthel Index to define if it improved more in the EOTIPS group compared to the control group.
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.
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Functional Independence Assessed With Barthel Index
After intervention (3 months).
|
85 score on a scale
Standard Error 16.7
|
90 score on a scale
Standard Error 14.9
|
|
Patient Functional Independence Assessed With Barthel Index
Before intervention (baseline).
|
52.5 score on a scale
Standard Error 21
|
54.7 score on a scale
Standard Error 20.5
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: The functional independence was assessed with SIS-16 to define if it improved more in the EOTIPS group compared to the control group.
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.
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Functional Independence Assessed With Stroke Impact Scale-16
After intervention (3 months).
|
61.9 score on a scale
Standard Deviation 12.6
|
66.3 score on a scale
Standard Deviation 10.7
|
|
Patient Functional Independence Assessed With Stroke Impact Scale-16
Before intervention (baseline).
|
36.60 score on a scale
Standard Deviation 14.00
|
37.70 score on a scale
Standard Deviation 11.00
|
SECONDARY outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: 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.
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).
Outcome measures
| Measure |
Control Group
n=30 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=30 Participants
Patients 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.
|
|---|---|---|
|
Patient Disability Assessed With Modified Rankin Scale (mRs)
After intervention (3 months).
|
2.5 Score on a scale
Standard Deviation 1.04
|
1.83 Score on a scale
Standard Deviation 1.05
|
|
Patient Disability Assessed With Modified Rankin Scale (mRs)
Before intervention (baseline).
|
3.60 Score on a scale
Standard Deviation 0.77
|
3.63 Score on a scale
Standard Deviation 0.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: The caregivers that wanted to participate in the study were evaluated.
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.
Outcome measures
| Measure |
Control Group
n=27 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=28 Participants
Patients 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.
|
|---|---|---|
|
Caregiver Burden.
After intervention (3 months).
|
3.91 Score on a scale
Standard Deviation 0.70
|
3.41 Score on a scale
Standard Deviation 0.69
|
|
Caregiver Burden.
Before intervention (baseline).
|
12.8 Score on a scale
Standard Deviation 12.6
|
14.5 Score on a scale
Standard Deviation 6.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before intervention (baseline) and after intervention (3 months)Population: The caregivers that were involved in the recovery of the patients were included in the study and evaluated.
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.
Outcome measures
| Measure |
Control Group
n=27 Participants
Patients in control group received usual/standard care.
|
OT Intervention.
n=28 Participants
Patients 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.
|
|---|---|---|
|
Caregivers Coping Strategies.
Engagement strategies - BEFORE
|
38.2 Score on a scale
Standard Deviation 12.6
|
42.5 Score on a scale
Standard Deviation 10.2
|
|
Caregivers Coping Strategies.
Disengagement strategies - BEFORE
|
33.9 Score on a scale
Standard Deviation 6.8
|
36.4 Score on a scale
Standard Deviation 8.18
|
|
Caregivers Coping Strategies.
Engagement strategies - AFTER
|
40.8 Score on a scale
Standard Deviation 13.6
|
49.0 Score on a scale
Standard Deviation 10.5
|
|
Caregivers Coping Strategies.
Disengagement strategies - AFTER
|
37.4 Score on a scale
Standard Deviation 7.95
|
38.0 Score on a scale
Standard Deviation 7.6
|
Adverse Events
Control Group - Patients
OT Intervention (EOTIPS) - Patients
Control Group - Caregivers
OT Intervention (EOTIPS) - Caregivers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place