Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03792061

Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan

Loading trial locations.

About this study

The proposed study will examine the efficacy of a newly developed intervention program, the Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving participation in productivity, social activities, and community among community-dwelling people with cognitive impairments after stroke. The OPASS program were developed based on the theoretical tenets of strategy training, with the goal of helping participants to set their participation goals, identify barriers to their performance, develop strategies to address these barriers, and generalize their learning through iterative practice. To examine the efficacy of OPASS, the following objectives will be addressed in this study:

  • To examine whether, compared to a control group, participating in the OPASS program will improve participation in productivity, social, and community domains in stroke survivors with cognitive impairments;
  • To determine whether the changes in participation after the intervention is correlated with changes in applied cognition, daily activities, executive functioning, and self-efficacy.
  • To examine whether the intervention effect sustains at 3-, 6-, and 12-month following the intervention.

To address this purpose, parallel-group randomized controlled trial will be implemented to assess the efficacy of the OPASS program in comparison to the control group. An expected sample of 210 adults with stroke-related cognitive impairments and are undergoing outpatient rehabilitation services will be recruited from our collaborative sites in Northern Taiwan. These participants will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio.

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). Data will be analyzed using multiple linear regression models and mixed-effects regression models. Of the recruited participants, 100 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(T1), post-intervention(T2), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models.

Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From baseline to 6-8 weeks (post-intervention)

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

Secondary outcomes

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

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

    The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.

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

    Time frame: From baseline to 3-month follow-up

    The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.

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

    Time frame: From baseline to 6-month follow-up

    The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.

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

    Time frame: From baseline to 12-month follow-up

    The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.

  5. HEAL positive outlook questionnaire

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

    he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.

  6. General self-efficacy Scale (GSES)

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

    The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.

  7. General self-efficacy Scale (GSES)

    Time frame: From baseline to 3-month follow-up

    The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.

  8. General self-efficacy Scale (GSES)

    Time frame: From baseline to 6-month follow-up

    The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.

  9. General self-efficacy Scale (GSES)

    Time frame: From baseline to 12-month follow-up

    The GSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.

  10. Canadian Occupational Performance Measure (COPM)

    Time frame: From the first session to the last session of the study, up to 8 weeks

    The COPM inquires the client to identify important goals in their daily life and rate their performance and satisfaction for each goal on a 10-point visual analog scale.

  11. Stroop Test

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

    Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.

  12. Stroop Test

    Time frame: From baseline to 3-month follow-up

    Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.

  13. Stroop Test

    Time frame: From baseline to 6-month follow-up

    Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.

  14. Stroop Test

    Time frame: From baseline to 12-month follow-up

    Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.

  15. Trail-Making Test (TMT A and B)

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

    Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.

  16. Trail-Making Test (TMT A and B)

    Time frame: From baseline to 3-month follow-up

    Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.

  17. Trail-Making Test (TMT A and B)

    Time frame: From baseline to 6-month follow-up

    Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.

  18. Trail-Making Test (TMT A and B)

    Time frame: From baseline to 12-month follow-up

    Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.

  19. Montreal Cognitive Assessment (MoCA)

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

    MoCA Test allows people to quickly assess a patients cognitive health.

  20. Montreal Cognitive Assessment (MoCA)

    Time frame: From baseline to 3-month follow-up

    MoCA Test allows people to quickly assess a patients cognitive health.

  21. Montreal Cognitive Assessment (MoCA)

    Time frame: From baseline to 6-month follow-up

    MoCA Test allows people to quickly assess a patients cognitive health.

  22. Montreal Cognitive Assessment (MoCA)

    Time frame: From baseline to 12-month follow-up

    MoCA Test allows people to quickly assess a patients cognitive health.

  23. The National Institutes of Health Stroke scale (NIHSS)

    Time frame: From baseline to 3-month, 6-month, and 12-month follow-ups

    The National Institutes of Health Stroke scale (NIHSS) will be used to assess participant's health related quality of life.

  24. modified Rankin Scale (MRS)

    Time frame: From baseline to 3-month, 6-month, and 12-month follow-ups

    The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.

  25. Euro-QoL-5-Dimension (EQ-5D)

    Time frame: From baseline to 3-month, 6-month, and 12-month follow-ups

    The Euro-QoL-5-Dimension (EQ-5D) will be used to assess participant's health related quality of life.

  26. Qualitative data

    Time frame: After intervention, an average of 2 months

    Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected.

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

    Time frame: From baseline to 3-month follow-up

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

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

    Time frame: From baseline to 6-month follow-up

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

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

    Time frame: From baseline to 12-month follow-up

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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Adopting Strategy Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2019
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.