Clinical trial NCT04941482: Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
Official title: Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Brain Infarction
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Keywords: Stroke
Mental Health
Physical activity
Cognitive therapy
Motivational Interviewing
fNIRs
Functional near-infrared spectroscopy
Rehabilitation
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: National Geriatric Hospital
First posted: 2021-06-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of registered 92 stroke patients in Vietnam National Geriatrics Hospital will be included in the study for 6 months. Included patients will be randomized to an intervention group and received the long-term follow-up program or to a control group receiving standard care.
Primary purpose: PREVENTION

Brief summary: This is a multi-intervention randomized controlled trial that aimed to develop a management pattern for stroke survivors. The program consists 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 will be 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 registered 92 stroke patients in Vietnam National Geriatrics Hospital will be included in the study for 6 months. Included patients will be 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 will be 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 includes 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 will be 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 will include 92 post-stroke patients with dividing two groups (46 control \& 46 intervention subjects), who experience emergency by stroke within one week. A multi-intervention program will design 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 report; \[3\] using the motivational interviewing methods to improve and prevent mental disorder; \[4\] applicating 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 will be collected via study questionnaires and fNIRS measuring results which are administered by researchers in the study site at 0, 1, 3, and 6 months follow-up. Simultaneously, 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 scores of the Stroke Impact Scale (SIS), physical and mental assessment scales and fNIRS data in both the groups will be used to calculate the effect estimates of intervention methods with a measure of precision (95% CI) and assessed the results of the trial.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline Stroke Impact Scale (SIS) at 1, 3, and 6 months
timeFrame: Baseline, 1, 3, and 6 months post intervention
measure: Changes from Baseline Barthel Index (BI) at 1, 3, and 6 months
timeFrame: Baseline, 1, 3, and 6 months post intervention
measure: Changes from Baseline Mini-Mental State Examination (MMSE) at 1, 3, and 6 months
timeFrame: Baseline, 1, 3, and 6 month post intervention
measure: Changes from Baseline Patient Health Questionnaire (PHQ-9) at 1, 3, and 6 months
timeFrame: Baseline, 1, 3, and 6 months post intervention
Secondary outcomes:
measure: Fatigue severity scale (FSS)
timeFrame: Baseline, 1, 3, and 6 months post intervention
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline, 1, 3, and 6 month post intervention
measure: Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
timeFrame: Baseline, 1, 3, and 6 month post intervention
measure: Fagerström Test for Nicotine Dependence (FTND)
timeFrame: Baseline, 1, 3, and 6 months post intervention
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Geriatrics Hospital
Study officials:
affiliation: Hanoi Medical University, Hanoi 100000, Viet Nam
name: Thao TP Nguyen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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