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

NCT04941482 | Completed Results

• 2 other identifiers: 9720701494/GCN-HDDDNCYSH-DHYHN
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline, 1, 3, and 6 months post intervention

• 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.

  Baseline, 1, 3, and 6 months post intervention

• 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.

  Baseline, 1, 3, and 6 month post intervention

• 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).

  Baseline, 1, 3, and 6 months post intervention

• 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.

  Baseline, 1, 3, and 6 months post intervention

Secondary Outcomes (1)

• Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months

  Baseline, 1, 3, and 6 months post intervention

Study Arms (2)

Multi-intervention program

EXPERIMENTAL

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.

Behavioral: Periodic health check program for post-stroke; Behavioral: Guiding the appropriate rehabilitation exercises; Behavioral: Motivational Interviewing; Device: Functional near-infrared spectroscopy

Standard care

ACTIVE COMPARATOR

The control group received the standard health check and was measured by an fNIRS device.

Behavioral: Periodic health check program for post-stroke; Device: Functional near-infrared spectroscopy

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.

Multi-intervention program; Standard care

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.

Multi-intervention program

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.

Also known as: Cognitive therapy

Multi-intervention program

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.

Also known as: fNIRS

Multi-intervention program; Standard care

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanoi Medical University: lead
• National Geriatric Hospital: collaborator

Study Sites (1)

National Geriatrics Hospital

Hanoi, 100000, Vietnam

Location

Related Publications (7)

• Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.

  PMID: 27291521 BACKGROUND

• Cheng D, Qu Z, Huang J, Xiao Y, Luo H, Wang J. Motivational interviewing for improving recovery after stroke. Cochrane Database Syst Rev. 2015 Jun 3;2015(6):CD011398. doi: 10.1002/14651858.CD011398.pub2.

  PMID: 26037617 BACKGROUND

• Petersen TH, Willerslev-Olsen M, Conway BA, Nielsen JB. The motor cortex drives the muscles during walking in human subjects. J Physiol. 2012 May 15;590(10):2443-52. doi: 10.1113/jphysiol.2012.227397. Epub 2012 Mar 5.

  PMID: 22393252 BACKGROUND

• Miyai I, Yagura H, Hatakenaka M, Oda I, Konishi I, Kubota K. Longitudinal optical imaging study for locomotor recovery after stroke. Stroke. 2003 Dec;34(12):2866-70. doi: 10.1161/01.STR.0000100166.81077.8A. Epub 2003 Nov 13.

  PMID: 14615624 BACKGROUND

• Strangman G, Goldstein R, Rauch SL, Stein J. Near-infrared spectroscopy and imaging for investigating stroke rehabilitation: test-retest reliability and review of the literature. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S12-9. doi: 10.1016/j.apmr.2006.07.269.

  PMID: 17140875 BACKGROUND

• Mihara M, Miyai I. Review of functional near-infrared spectroscopy in neurorehabilitation. Neurophotonics. 2016 Jul;3(3):031414. doi: 10.1117/1.NPh.3.3.031414. Epub 2016 Jul 12.

  PMID: 27429995 BACKGROUND

• Nguyen TTP, Hoang HB, Vu HTT. Effectiveness of multifaceted interventions including motivational interviewing and home-based rehabilitation program for improving mental and physical health in stroke patients: A randomized controlled trial. Int J Nurs Stud Adv. 2024 Oct 30;7:100259. doi: 10.1016/j.ijnsa.2024.100259. eCollection 2024 Dec.

  PMID: 39610664 DERIVED

MeSH Terms

Conditions

Stroke; Brain Infarction; Brain Ischemia; Cerebral Infarction; Cerebrovascular Disorders; Psychological Well-Being; Motor Activity

Interventions

Motivational Interviewing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Limitations and Caveats

Our study had several limitations as follows: Firstly, the small sample size limited a thorough exploration of underlying mechanisms. Secondly, participant heterogeneity may have influenced outcomes. Future research should employ more detailed recruitment methods. Lastly, the 6-month follow-up period may not fully capture the long-term impacts of the intervention. Further investigation is needed to assess sustainability.

Results Point of Contact

• Title: Dr. Thao Thi Phuong Nguyen
• Organization: Hanoi Medical University

dr.nguyenthiphuongthao.hmu@gmail.com

+84916911897

Study Officials

• Thao TP Nguyen, MD, MSc

  Hanoi Medical University, Hanoi 100000, Viet Nam

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 28, 2021
• Study Start: August 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)