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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT04941482 |
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Date of registration:
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10/06/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
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Scientific title:
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Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients. |
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Date of first enrolment:
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August 1, 2021 |
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Target sample size:
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92 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04941482 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Huyen TT Vu, MD, PhD |
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Address:
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Telephone:
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+84913531579 |
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Email:
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vuthanhhuyen11@hmu.edu.vn |
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Affiliation:
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Name:
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Thao TP Nguyen, MD, MSc |
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Address:
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Telephone:
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+84916911897 |
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Email:
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dr.nguyenthiphuongthao.hmu@gmail.com |
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Affiliation:
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Name:
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Thao TP Nguyen, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hanoi Medical University, Hanoi 100000, Viet Nam |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Brain Infarction
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Brain Ischemia
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Cerebral Infarction
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Cerebrovascular Disorders
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Stroke
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Intervention(s)
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Behavioral: Guiding the appropriate rehabilitation exercises
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Behavioral: Motivational Interviewing
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Behavioral: Periodic health check program for post-stroke
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Device: Functional near-infrared spectroscopy
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Primary Outcome(s)
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Changes from Baseline Barthel Index (BI) at 1, 3, and 6 months
[Time Frame: Baseline, 1, 3, and 6 months post intervention]
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Changes from Baseline Mini-Mental State Examination (MMSE) at 1, 3, and 6 months
[Time Frame: Baseline, 1, 3, and 6 month post intervention]
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Changes from Baseline Patient Health Questionnaire (PHQ-9) at 1, 3, and 6 months
[Time Frame: Baseline, 1, 3, and 6 months post intervention]
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Changes from Baseline Stroke Impact Scale (SIS) at 1, 3, and 6 months
[Time Frame: Baseline, 1, 3, and 6 months post intervention]
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Secondary Outcome(s)
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Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
[Time Frame: Baseline, 1, 3, and 6 month post intervention]
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Fagerström Test for Nicotine Dependence (FTND)
[Time Frame: Baseline, 1, 3, and 6 months post intervention]
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Fatigue severity scale (FSS)
[Time Frame: Baseline, 1, 3, and 6 months post intervention]
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Pittsburgh sleep quality index (PSQI)
[Time Frame: Baseline, 1, 3, and 6 month post intervention]
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Secondary ID(s)
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494/GCN-HDDDNCYSH-DHYHN
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9720701
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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