Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.

Not Applicable

Completed

Conditions: Brain Infarction
Cerebrovascular Disorders
Cerebral Infarction
Brain Ischemia
Stroke

Registration Number: NCT04941482

Lead Sponsor: Hanoi Medical University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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