Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders, Stroke
Conditions
Keywords
Stroke, Mental Health, Physical activity, Cognitive therapy, Motivational Interviewing, fNIRs, Functional near-infrared spectroscopy, Rehabilitation
Brief summary
This was a multi-intervention randomized controlled trial that aimed to develop a management pattern for stroke survivors. The program consisted of monitoring the recovery process, early detecting the physical and mental disorders, suitably intervening for each patient to improve their quality of life. New intervention techniques were firstly applied for post-stroke patients in Vietnam such as using the portable functional near-infrared spectroscopy (fNIRS) device to explore cortex frontal hemodynamic and motivational interviewing for psychological adjustment. A total of 92 stroke patients registered in Vietnam National Geriatrics Hospital were included in the study for 6 months. Included patients were randomized to an intervention group and received the long-term follow-up program or to a control group receiving standard care. The mental health and physical functioning of participants were assessed at 0, 1, 3, and 6 months follow-up. This work was funded by Vingroup Joint Stock Company and supported by the Domestic Master/Ph.D. Scholarship Programme of Vingroup Innovation Foundation (VINIF), Vingroup Big Data Institute (VINBIGDATA).
Detailed description
Stroke is a medical condition that occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts (or ruptures). This is a major cause of death and disability worldwide. Post-stroke patients will experience sudden and intense changes in their physical and mental health during the first year. Currently, there is no official management model for improving the physical and mental health of patients after stroke in Vietnam. Furthermore, traditional neuroimaging techniques such as Functional magnetic resonance imaging (fMRI), Positron emission tomography (PET), Electroencephalogram (EEG) are not suitable for routine monitoring due to limited flexibility dynamics and costs. Hence, this study aimed to develop a management pattern that included monitoring the recovery process, early detecting the physical and mental disorders, suitably intervening for each patient to improve their quality of life. New intervention techniques were firstly applied for post-stroke patients in Vietnam such as using the portable fNIRS device to explore cortex frontal hemodynamic and motivational interviewing for psychological adjustment. This randomized controlled trial study included 92 post-stroke patients with dividing into two groups (46 control & 46 intervention subjects), who experienced emergency by stroke within one week. A multi-intervention program was designed for stroke patients including \[1\] periodic health examination for assessment of physical and mental health, recurrence risks, and harmful behaviors; \[2\] guiding the appropriate rehabilitation exercises for improving the physical status and monitoring through daily online reports; \[3\] using motivational interviewing methods to improve and prevent mental disorder; \[4\] application of the technique of functional near-infrared spectroscopy (fNIRS) for measurement of oxy-hemoglobin on cortex prefrontal to early detect mental disorder and stroke recurrence risks. Outcome data were collected via study questionnaires and fNIRS measuring results which were administered by researchers in the study site at 0, 1, 3, and 6 months follow-up. Simultaneously, Motivational Interviewing was carried out on post-stroke patients in the first three months (one time per week in the first month and one time per second and third month). This intervention method aimed to discover and resolve patient's conflicts by standardized communication skill to improve their mental health and change negative behaviors. The scores of the Stroke Impact Scale (SIS), physical and mental assessment scales and fNIRS data in both groups were used to calculate the effect estimates of intervention methods with a measure of precision (95% CI) and assess the results of the trial.
Interventions
BEHAVIORALPeriodic health check program for post-stroke
The stroke survivors were assessed for their physical and mental health, recurrence risks, and harmful behaviors at 0, 1, 3, and 6 months using specific scales.
BEHAVIORALGuiding the appropriate rehabilitation exercises
The appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report.
BEHAVIORALMotivational Interviewing
Motivational Interviewing will carry out on post-stroke patients in the first three months (one time per week in the first month and one time per the second and third month). This intervention method aims to discover and resolve patient's conflicts by a standardized communication skill to improve their mental health and change negative behaviors.
The fNIRS devices served as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity and stroke rehabilitation and recovery. Moreover, the cortex hemodynamic measurement by fNIRS could detect various mental disorders such as depression, anxiety, schizophrenia early through cognitive tasks.
Sponsors
National Geriatric Hospital
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
92 stroke patients registered at the Vietnam National Geriatrics Hospital were enrolled in the study for 6 months. The patients were randomly assigned to either an intervention group that received the long-term follow-up program, or a control group that received standard care.
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stroke according to WHO's definition of stroke * Are managed at the National Geriatrics Hospital in Vietnam * Include 24 hours to 1 week after stroke * Provide informed consent * Willing to attend intervention therapies & follow-up evaluations for half-year. * Have conscious, cognitive, and communication abilities.
Exclusion criteria
* Do not agree to participate in the study * Are included in other experimental studies * Have mental disorders before stroke attack * Glasgow score ≤ 8 * Other diseases that make it difficult to complete the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | Baseline, 1, 3, and 6 months post intervention | The Patient Health Questionnaire-9 is a screening tool for post-stroke depression and assessing the changes at baseline, 1, 3, and 6 months. The possible range is 0-27 and the higher scores mean worse outcomes. |
| Fatigue Severity Scale (FSS) | Baseline, 1, 3, and 6 months post intervention | Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire. Each item is rated 1 (strongly disagree) to 7 (strongly agree). The total score is the \*\*sum of the 9 items (range 9-63); higher scores indicate greater fatigue severity (worse outcome). The total score (9-63) was analyzed at baseline, 1, 3, and 6 months. If ≤1 item was missing, the item was imputed per instrument guidance; otherwise the score was set to missing. |
| Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | Baseline, 1, 3, and 6 month post intervention | Mini-Mental State Examination is a screening tool for post-stroke cognitive impairment. Scores range from 0 to 30 points, with lower scores indicating greater impairment. |
| Changes From Baseline Barthel Index at 1, 3, and 6 Months | Baseline, 1, 3, and 6 months post intervention | Measure the changes of activities of daily living through assessing functional independence during half-year post-randomization. The score of the Barthel Index ranging from 0 to 100 was collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome). |
| Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | Baseline, 1, 3, and 6 months post intervention | The Stroke Impact Scale evaluates the post-stroke quality of life, utilizing a scoring system ranging from 0 to 100, higher scores denote improved quality of life. This scale consists of 08 domains, including (1) strength; (2) memory; (3) emotion; (4) communication; (5) activities of daily living independence; (6) mobility; (7) hand function; and (8) participation. The Physical domain was calculated from the domains by averaging the values (1+5+6+7)/4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | Baseline, 1, 3, and 6 months post intervention | The Stroke Impact Scale evaluates the post-stroke quality of life, utilizing a scoring system ranging from 0 to 100, higher scores denote improved quality of life. This scale consists of 08 domains, including (1) strength; (2) memory; (3) emotion; (4) communication; (5) activities of daily living independence; (6) mobility; (7) hand function; and (8) participation |
Countries
Vietnam
Participant flow
Recruitment details
From December 2021 to March 2022, individuals participating in the study were selected from the statistical list of stroke patients diagnosed by a neurologist at the National Geriatric Hospital.
Pre-assignment details
Of 129 individuals assessed for eligibility (screened), 92 provided informed consent and were randomized (46 per arm). 37 were excluded due to not meeting the inclusion criteria, declining to participate, or other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Multi-intervention Program A multi-intervention program was designed for intervention groups, including:
1. Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
2. Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
3. Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
4. Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks. | 46 |
| Standard Care The control group received the standard health check and fNIRS measure:
1. Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
2. Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, schizophrenia... through cognitive tasks. | 46 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | At the time of confirming dropout, the dropout patients had not experienced any SAEs or fatalities. | 9 | 3 |
Baseline characteristics
| Characteristic | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 10.2 | 69.8 years STANDARD_DEVIATION 12.1 | 72.2 years STANDARD_DEVIATION 11.4 |
| Blood pressure High (≥140 mmHg and/or ≥90 mmHg) | 18 Participants | 12 Participants | 30 Participants |
| Blood pressure Normal (<140 mmHg/<90 mmHg) | 28 Participants | 34 Participants | 62 Participants |
| Body mass index (BMI) Normal (18.5-24.9) | 28 Participants | 29 Participants | 57 Participants |
| Body mass index (BMI) Overweight (25.0-29.9)/ Obese (≥30.0) | 18 Participants | 17 Participants | 35 Participants |
| Charlson Comorbidity Index (CCI) | 5.7 units on a scale STANDARD_DEVIATION 1.5 | 5.4 units on a scale STANDARD_DEVIATION 1.4 | 5.6 units on a scale STANDARD_DEVIATION 1.5 |
| Disability levels of stroke survivors - MRS Moderate disability (3) | 9 Participants | 6 Participants | 15 Participants |
| Disability levels of stroke survivors - MRS Moderate-severe disability (4) | 18 Participants | 23 Participants | 41 Participants |
| Disability levels of stroke survivors - MRS No significant disability (1) | 9 Participants | 12 Participants | 21 Participants |
| Disability levels of stroke survivors - MRS No symptoms (0) | 5 Participants | 1 Participants | 6 Participants |
| Disability levels of stroke survivors - MRS Slight disability (2) | 5 Participants | 4 Participants | 9 Participants |
| Duration from stroke onset to participate in the study 1 month to < 3 months | 9 Participants | 11 Participants | 20 Participants |
| Duration from stroke onset to participate in the study 3 months to < 6 months | 22 Participants | 19 Participants | 41 Participants |
| Duration from stroke onset to participate in the study 6 months to 1 year | 15 Participants | 16 Participants | 31 Participants |
| Education High school & upper | 26 Participants | 34 Participants | 60 Participants |
| Education Secondary school & lower | 20 Participants | 12 Participants | 32 Participants |
| Employment status Active | 21 Participants | 31 Participants | 52 Participants |
| Employment status Inactive | 25 Participants | 15 Participants | 40 Participants |
| Frequency of stroke occurrences Once | 34 Participants | 31 Participants | 65 Participants |
| Frequency of stroke occurrences Twice or more | 12 Participants | 15 Participants | 27 Participants |
| Hemispheric lesion locations Left-sided | 6 Participants | 0 Participants | 6 Participants |
| Hemispheric lesion locations Right-sided | 17 Participants | 24 Participants | 41 Participants |
| Hemispheric lesion locations Unknown | 23 Participants | 22 Participants | 45 Participants |
| Marital status Living with spouse | 24 Participants | 26 Participants | 50 Participants |
| Marital status Single, widow/widower | 22 Participants | 20 Participants | 42 Participants |
| National Institutes of Health Stroke Scale - NIHSS (score) | 5.9 units on a scale STANDARD_DEVIATION 4.6 | 9.2 units on a scale STANDARD_DEVIATION 6.4 | 7.6 units on a scale STANDARD_DEVIATION 5.8 |
| Poor sleep quality - Pittsburgh Sleep Quality Index No | 8 Participants | 16 Participants | 24 Participants |
| Poor sleep quality - Pittsburgh Sleep Quality Index Yes | 38 Participants | 30 Participants | 68 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 48 Participants |
| Stroke classification Hemorrhage | 5 Participants | 7 Participants | 12 Participants |
| Stroke classification Ischemia | 21 Participants | 15 Participants | 36 Participants |
| Stroke classification Unknown | 20 Participants | 24 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
Changes From Baseline Barthel Index at 1, 3, and 6 Months
Measure the changes of activities of daily living through assessing functional independence during half-year post-randomization. The score of the Barthel Index ranging from 0 to 100 was collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).
Time frame: Baseline, 1, 3, and 6 months post intervention
Population: Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi-intervention Program | Changes From Baseline Barthel Index at 1, 3, and 6 Months | Baseline | 55.5 units on a scale | Standard Deviation 36.2 |
| Multi-intervention Program | Changes From Baseline Barthel Index at 1, 3, and 6 Months | After 1 month | 58.8 units on a scale | Standard Deviation 35.2 |
| Multi-intervention Program | Changes From Baseline Barthel Index at 1, 3, and 6 Months | After 3 months | 68.8 units on a scale | Standard Deviation 28.6 |
| Multi-intervention Program | Changes From Baseline Barthel Index at 1, 3, and 6 Months | After 6 months | 68.8 units on a scale | Standard Deviation 28.6 |
| Standard Care | Changes From Baseline Barthel Index at 1, 3, and 6 Months | After 6 months | 54.5 units on a scale | Standard Deviation 33 |
| Standard Care | Changes From Baseline Barthel Index at 1, 3, and 6 Months | Baseline | 55.4 units on a scale | Standard Deviation 34.3 |
| Standard Care | Changes From Baseline Barthel Index at 1, 3, and 6 Months | After 3 months | 56.2 units on a scale | Standard Deviation 33.3 |
| Standard Care | Changes From Baseline Barthel Index at 1, 3, and 6 Months | After 1 month | 55.7 units on a scale | Standard Deviation 33.9 |
Comparison: We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.p-value: <0.0595% CI: [-14.5, 14.7]t-test, 2 sided
Primary
Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months
Mini-Mental State Examination is a screening tool for post-stroke cognitive impairment. Scores range from 0 to 30 points, with lower scores indicating greater impairment.
Time frame: Baseline, 1, 3, and 6 month post intervention
Population: Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi-intervention Program | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | Baseline | 16.2 units on a scale | Standard Deviation 7 |
| Multi-intervention Program | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | After 1 month | 13.5 units on a scale | Standard Deviation 9.7 |
| Multi-intervention Program | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | After 3 months | 17.9 units on a scale | Standard Deviation 10.3 |
| Multi-intervention Program | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | After 6 months | 19.5 units on a scale | Standard Deviation 10.6 |
| Standard Care | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | After 6 months | 15.0 units on a scale | Standard Deviation 8.3 |
| Standard Care | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | Baseline | 18.3 units on a scale | Standard Deviation 8.9 |
| Standard Care | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | After 3 months | 16.2 units on a scale | Standard Deviation 7.6 |
| Standard Care | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | After 1 month | 18.5 units on a scale | Standard Deviation 8.7 |
Comparison: We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.p-value: <0.0595% CI: [-5.4, 1.3]t-test, 2 sided
Primary
Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months
The Stroke Impact Scale evaluates the post-stroke quality of life, utilizing a scoring system ranging from 0 to 100, higher scores denote improved quality of life. This scale consists of 08 domains, including (1) strength; (2) memory; (3) emotion; (4) communication; (5) activities of daily living independence; (6) mobility; (7) hand function; and (8) participation. The Physical domain was calculated from the domains by averaging the values (1+5+6+7)/4.
Time frame: Baseline, 1, 3, and 6 months post intervention
Population: Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi-intervention Program | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | Baseline | 36.9 units on a scale | Standard Deviation 24.8 |
| Multi-intervention Program | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | After 1 month | 28.4 units on a scale | Standard Deviation 24.3 |
| Multi-intervention Program | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | After 3 months | 34.7 units on a scale | Standard Deviation 26.7 |
| Multi-intervention Program | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | After 6 months | 38.5 units on a scale | Standard Deviation 26.8 |
| Standard Care | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | After 6 months | 32.0 units on a scale | Standard Deviation 27.3 |
| Standard Care | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | Baseline | 44.4 units on a scale | Standard Deviation 29.3 |
| Standard Care | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | After 3 months | 38.2 units on a scale | Standard Deviation 27.7 |
| Standard Care | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | After 1 month | 37.8 units on a scale | Standard Deviation 28 |
Comparison: We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.p-value: <0.0595% CI: [-18.8, 3.7]t-test, 2 sided
Primary
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months
The Patient Health Questionnaire-9 is a screening tool for post-stroke depression and assessing the changes at baseline, 1, 3, and 6 months. The possible range is 0-27 and the higher scores mean worse outcomes.
Time frame: Baseline, 1, 3, and 6 months post intervention
Population: Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi-intervention Program | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | Baseline | 10.9 units on a scale | Standard Deviation 6.5 |
| Multi-intervention Program | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | After 1 month | 9.1 units on a scale | Standard Deviation 1 |
| Multi-intervention Program | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | After 3 months | 3.1 units on a scale | Standard Deviation 2.8 |
| Multi-intervention Program | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | After 6 months | 1.8 units on a scale | Standard Deviation 1.9 |
| Standard Care | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | After 6 months | 25.6 units on a scale | Standard Deviation 2.9 |
| Standard Care | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | Baseline | 10.3 units on a scale | Standard Deviation 5.9 |
| Standard Care | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | After 3 months | 24.5 units on a scale | Standard Deviation 2.8 |
| Standard Care | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | After 1 month | 19.7 units on a scale | Standard Deviation 3.8 |
Comparison: We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.p-value: <0.0595% CI: [-1.9, 3.2]t-test, 2 sided
Primary
Fatigue Severity Scale (FSS)
Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire. Each item is rated 1 (strongly disagree) to 7 (strongly agree). The total score is the \*\*sum of the 9 items (range 9-63); higher scores indicate greater fatigue severity (worse outcome). The total score (9-63) was analyzed at baseline, 1, 3, and 6 months. If ≤1 item was missing, the item was imputed per instrument guidance; otherwise the score was set to missing.
Time frame: Baseline, 1, 3, and 6 months post intervention
Population: Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi-intervention Program | Fatigue Severity Scale (FSS) | Baseline | 35.2 units on a scale | Standard Deviation 12.9 |
| Multi-intervention Program | Fatigue Severity Scale (FSS) | After 1 month | 28.5 units on a scale | Standard Deviation 11.8 |
| Multi-intervention Program | Fatigue Severity Scale (FSS) | After 3 months | 17.8 units on a scale | Standard Deviation 5.9 |
| Multi-intervention Program | Fatigue Severity Scale (FSS) | After 6 months | 14.4 units on a scale | Standard Deviation 4.9 |
| Standard Care | Fatigue Severity Scale (FSS) | After 6 months | 57.9 units on a scale | Standard Deviation 7.6 |
| Standard Care | Fatigue Severity Scale (FSS) | Baseline | 37.8 units on a scale | Standard Deviation 11.4 |
| Standard Care | Fatigue Severity Scale (FSS) | After 3 months | 53.9 units on a scale | Standard Deviation 8.1 |
| Standard Care | Fatigue Severity Scale (FSS) | After 1 month | 43.4 units on a scale | Standard Deviation 8.7 |
Comparison: We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.p-value: <0.0595% CI: [-7.6, 2.5]t-test, 2 sided
Secondary
Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months
The Stroke Impact Scale evaluates the post-stroke quality of life, utilizing a scoring system ranging from 0 to 100, higher scores denote improved quality of life. This scale consists of 08 domains, including (1) strength; (2) memory; (3) emotion; (4) communication; (5) activities of daily living independence; (6) mobility; (7) hand function; and (8) participation
Time frame: Baseline, 1, 3, and 6 months post intervention
Population: Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi-intervention Program | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | Baseline | 45.4 units on a scale | Standard Deviation 16.4 |
| Multi-intervention Program | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | After 1 month | 48.3 units on a scale | Standard Deviation 15.3 |
| Multi-intervention Program | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | After 3 months | 58.5 units on a scale | Standard Deviation 15.1 |
| Multi-intervention Program | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | After 6 months | 62.6 units on a scale | Standard Deviation 13.8 |
| Standard Care | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | After 6 months | 37.0 units on a scale | Standard Deviation 18.8 |
| Standard Care | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | Baseline | 53.2 units on a scale | Standard Deviation 19.2 |
| Standard Care | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | After 3 months | 40.5 units on a scale | Standard Deviation 19.2 |
| Standard Care | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | After 1 month | 44.7 units on a scale | Standard Deviation 19.6 |
Comparison: We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.p-value: <0.0595% CI: [-15.2, -0.3]t-test, 2 sided