Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

NCT03792061 | Active Not Recruiting

• 1 other identifier: N201804055
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief Summary

Abstract Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version) will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Each session will be around 45 minutes and will be delivered 1 to 2 sessions per week for 12 to 15 sessions. Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5). Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear regression models and mixed-effects regression models.

Conditions

Stroke; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)

  The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.

  From baseline to 6-8 weeks (post-intervention)

Secondary Outcomes (29)

• Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms

  From baseline to up to 6-8 weeks (post-intervention)

• Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms

  From baseline to 3-month follow-up

• Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms

  From baseline to 6-month follow-up

• Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms

  From baseline to 12-month follow-up

• HEAL positive outlook questionnaire

  From baseline to up to 6-8 weeks (post-intervention)

Study Arms (2)

Strategy Training

EXPERIMENTAL

Strategy training is an activity intervention training approach developed based on the theoretical tenets of metacognitive training. The purpose of strategy training is to guide individuals to generate problem-solving skills to address challenges that they identify in daily activities.

Behavioral: Strategy Training

Reflective listening

NO INTERVENTION

Participants in the control group will receive dose-matched non-active intervention carried out by a trained research staff. The staff will use scripted questions to provoke participants to describe their experiences and feelings about their disease and their usual-care rehabilitation activities.

Interventions

Strategy Training BEHAVIORAL

This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.

Strategy Training

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 20 years and older
• Has a diagnosis of stroke
• Understand Mandarin
• Has cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version)
• Provide informed consent

You may not qualify if:

• Have severe aphasia
• Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (4)

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Medical University

Taipei, Taiwan

Location

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan

Location

Related Publications (3)

• Hsu SP, Hung TH, Lin YN, Kang JH, Han DS, Chiu V, Liou TH, Wu YH, Ni PS, Skidmore ER, Chang FH. Enhancing Societal Participation for Stroke Survivors With Cognitive Impairments: A Randomized Controlled Trial. J Am Heart Assoc. 2025 Oct 7;14(19):e042295. doi: 10.1161/JAHA.125.042295. Epub 2025 Sep 19.

  PMID: 40970531 DERIVED

• Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

  PMID: 35349186 DERIVED

• Chang FH, Chiu V, Ni P, Lin YN, Kang JH, Liou TH, Lu L, Han DS, Skidmore ER. Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan. BMJ Open. 2020 Dec 7;10(12):e040241. doi: 10.1136/bmjopen-2020-040241.

  PMID: 33293312 DERIVED

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Feng-Hang Chang, ScD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Graduate Institute of Injury Prevention and Control, Taipei Medical University

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 3, 2019
• Study Start: January 13, 2019
• Primary Completion: August 22, 2024
• Study Completion: December 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)