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Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

Primary Purpose

Stroke, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Strategy Training
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Medical University-Shuang Ho HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Medical UniversityRecruiting
  • Taipei Municipal Wan Fang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strategy Training

Reflective listening

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
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.
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
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.
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
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.
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
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.
HEAL positive outlook questionnaire
he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.
Participation Strategies self-efficacy Scale (PS-SES)
The PSSES 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.
Participation Strategies self-efficacy Scale (PS-SES)
The PSSES 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.
Participation Strategies self-efficacy Scale (PS-SES)
The PSSES 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.
Participation Strategies self-efficacy Scale (PS-SES)
The PSSES 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.
Canadian Occupational Performance Measure (COPM)
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.
Stroop Test
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.
Stroop Test
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.
Stroop Test
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.
Stroop Test
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.
Trail-Making Test (TMT A and B)
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.
Trail-Making Test (TMT A and B)
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.
Trail-Making Test (TMT A and B)
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.
Trail-Making Test (TMT A and B)
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.
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
Montreal Cognitive Assessment (MoCA)
MoCA Test allows people to quickly assess a patients cognitive health.
The National Institutes of Health Stroke scale (NIHSS)
The National Institutes of Health Stroke scale (NIHSS) will be used to assess participant's health related quality of life.
modified Rankin Scale (MRS)
The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.
Euro-QoL-5-Dimension (EQ-5D)
The Euro-QoL-5-Dimension (EQ-5D) will be used to assess participant's health related quality of life.
Qualitative data
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.
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.
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.
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.

Full Information

First Posted
January 1, 2019
Last Updated
March 31, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03792061
Brief Title
Enhancing Community Participation for Stroke Survivors With Cognitive Impairments
Official Title
Adopting Strategy Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strategy Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Reflective listening
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strategy Training
Intervention Description
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 Outcome Measure Information:
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to up to 6 weeks
Secondary Outcome Measure Information:
Title
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Description
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.
Time Frame
From baseline to up to 6 weeks
Title
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Description
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.
Time Frame
From baseline to 3-month follow-up
Title
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Description
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.
Time Frame
From baseline to 6-month follow-up
Title
Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
Description
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.
Time Frame
From baseline to 12-month follow-up
Title
HEAL positive outlook questionnaire
Description
he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.
Time Frame
From baseline to up to 6 weeks
Title
Participation Strategies self-efficacy Scale (PS-SES)
Description
The PSSES 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.
Time Frame
From baseline to up to 6 weeks
Title
Participation Strategies self-efficacy Scale (PS-SES)
Description
The PSSES 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.
Time Frame
From baseline to 3-month follow-up
Title
Participation Strategies self-efficacy Scale (PS-SES)
Description
The PSSES 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.
Time Frame
From baseline to 6-month follow-up
Title
Participation Strategies self-efficacy Scale (PS-SES)
Description
The PSSES 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.
Time Frame
From baseline to 12-month follow-up
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
From the first session to the last session of the study, up to 8 weeks
Title
Stroop Test
Description
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.
Time Frame
From baseline to up to 6 weeks
Title
Stroop Test
Description
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.
Time Frame
From baseline to 3-month follow-up
Title
Stroop Test
Description
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.
Time Frame
From baseline to 6-month follow-up
Title
Stroop Test
Description
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.
Time Frame
From baseline to 12-month follow-up
Title
Trail-Making Test (TMT A and B)
Description
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.
Time Frame
From baseline to up to 6 weeks
Title
Trail-Making Test (TMT A and B)
Description
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.
Time Frame
From baseline to 3-month follow-up
Title
Trail-Making Test (TMT A and B)
Description
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.
Time Frame
From baseline to 6-month follow-up
Title
Trail-Making Test (TMT A and B)
Description
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.
Time Frame
From baseline to 12-month follow-up
Title
Montreal Cognitive Assessment (MoCA)
Description
MoCA Test allows people to quickly assess a patients cognitive health.
Time Frame
From baseline to up to 6 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
MoCA Test allows people to quickly assess a patients cognitive health.
Time Frame
From baseline to 3-month follow-up
Title
Montreal Cognitive Assessment (MoCA)
Description
MoCA Test allows people to quickly assess a patients cognitive health.
Time Frame
From baseline to 6-month follow-up
Title
Montreal Cognitive Assessment (MoCA)
Description
MoCA Test allows people to quickly assess a patients cognitive health.
Time Frame
From baseline to 12-month follow-up
Title
The National Institutes of Health Stroke scale (NIHSS)
Description
The National Institutes of Health Stroke scale (NIHSS) will be used to assess participant's health related quality of life.
Time Frame
From baseline to 3-month, 6-month, and 12-month follow-ups
Title
modified Rankin Scale (MRS)
Description
The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.
Time Frame
From baseline to 3-month, 6-month, and 12-month follow-ups
Title
Euro-QoL-5-Dimension (EQ-5D)
Description
The Euro-QoL-5-Dimension (EQ-5D) will be used to assess participant's health related quality of life.
Time Frame
From baseline to 3-month, 6-month, and 12-month follow-ups
Title
Qualitative data
Description
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.
Time Frame
After intervention, an average of 2 months
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to 3-month follow-up
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to 6-month follow-up
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng-Hang Chang, ScD
Phone
886-2-2736-1661
Ext
6573
Email
fhchang@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-Hang Chang, ScD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsan-Hon Liou
Phone
886-2-2249-0088
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Lu
Phone
886-2-2312-3456
Facility Name
Taipei Medical University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng-Hang Chang
Phone
886-2-2736-1661
Ext
6573
Email
fhchang@tmu.edu.tw
Facility Name
Taipei Municipal Wan Fang Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin
Phone
886-2-2930-7930
Ext
1600

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD is not planned to be shared.
Citations:
PubMed Identifier
35349186
Citation
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.
Results Reference
derived
PubMed Identifier
33293312
Citation
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.
Results Reference
derived

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Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

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