Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03792061
• Other study ID #: N201804055
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 13, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. 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;

2. To determine whether the changes in participation after the intervention is correlated with changes in applied cognition, daily activities, executive functioning, and self-efficacy.

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: June 30, 2024
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

Behavioral:
• Strategy Training
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University	Taipei
Taiwan	Taipei Municipal Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 up to 6 weeks
Secondary	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.	From baseline to up to 6 weeks
Secondary	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.	From baseline to 3-month follow-up
Secondary	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.	From baseline to 6-month follow-up
Secondary	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.	From baseline to 12-month follow-up
Secondary	HEAL positive outlook questionnaire	he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.	From baseline to up to 6 weeks
Secondary	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.	From baseline to up to 6 weeks
Secondary	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.	From baseline to 3-month follow-up
Secondary	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.	From baseline to 6-month follow-up
Secondary	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.	From baseline to 12-month follow-up
Secondary	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.	From the first session to the last session of the study, up to 8 weeks
Secondary	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.	From baseline to up to 6 weeks
Secondary	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.	From baseline to 3-month follow-up
Secondary	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.	From baseline to 6-month follow-up
Secondary	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.	From baseline to 12-month follow-up
Secondary	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.	From baseline to up to 6 weeks
Secondary	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.	From baseline to 3-month follow-up
Secondary	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.	From baseline to 6-month follow-up
Secondary	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.	From baseline to 12-month follow-up
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA Test allows people to quickly assess a patients cognitive health.	From baseline to up to 6 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA Test allows people to quickly assess a patients cognitive health.	From baseline to 3-month follow-up
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA Test allows people to quickly assess a patients cognitive health.	From baseline to 6-month follow-up
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA Test allows people to quickly assess a patients cognitive health.	From baseline to 12-month follow-up
Secondary	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.	From baseline to 3-month, 6-month, and 12-month follow-ups
Secondary	modified Rankin Scale (MRS)	The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.	From baseline to 3-month, 6-month, and 12-month follow-ups
Secondary	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.	From baseline to 3-month, 6-month, and 12-month follow-ups
Secondary	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.	After intervention, an average of 2 months
Secondary	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 3-month follow-up
Secondary	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-month follow-up
Secondary	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 12-month follow-up