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

Sponsor
Hanoi Medical University
Study ID
NCT04941482
Status
Completed

Conditions

  • Brain Infarction
  • Brain Ischemia
  • Cerebral Infarction
  • Cerebrovascular Disorders
  • Stroke

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Periodic health check program for post-stroke — BEHAVIORAL
    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.
  • Guiding the appropriate rehabilitation exercises — BEHAVIORAL
    The appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report.
  • Motivational Interviewing — BEHAVIORAL
    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.
  • Functional near-infrared spectroscopy — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Aug 1, 2021
Status verified
Aug 2022
Primary completion
Dec 30, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Multi-intervention program
    A multi-intervention program was designed for stroke patients, including: \[1\] periodic health examinations for assessing physical and mental health, recurrence risks, and harmful behaviors; \[2\] guiding appropriate rehabilitation exercises to improve physical status and monitoring through daily online reports; \[3\] using motivational interviewing methods to improve and prevent mental disorders; \[4\] using the technique of functional near-infrared spectroscopy (fNIRS) to measure oxy-hemoglobin in the prefrontal cortex to early detect mental disorders and stroke recurrence risks.
  • Active Comparator: Standard care
    The control group received the standard health check and was measured by an fNIRS device.

Primary Outcome Measure

Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months [ Time Frame: Baseline, 1, 3, and 6 months post intervention ]

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