Clinical trial NCT03792061: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Cognitive Impairment
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to 6-8 weeks (post-intervention)
Secondary outcomes:
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: From baseline to up to 6-8 weeks (post-intervention)
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: From baseline to 3-month follow-up
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: From baseline to 6-month follow-up
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: From baseline to 12-month follow-up
measure: HEAL positive outlook questionnaire
timeFrame: From baseline to up to 6-8 weeks (post-intervention)
measure: General self-efficacy Scale (GSES)
timeFrame: From baseline to up to 6-8 weeks (post-intervention)
measure: General self-efficacy Scale (GSES)
timeFrame: From baseline to 3-month follow-up
measure: General self-efficacy Scale (GSES)
timeFrame: From baseline to 6-month follow-up
measure: General self-efficacy Scale (GSES)
timeFrame: From baseline to 12-month follow-up
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: From the first session to the last session of the study, up to 8 weeks
measure: Stroop Test
timeFrame: From baseline to up to 6-8 weeks (post-intervention)
measure: Stroop Test
timeFrame: From baseline to 3-month follow-up
measure: Stroop Test
timeFrame: From baseline to 6-month follow-up
measure: Stroop Test
timeFrame: From baseline to 12-month follow-up
measure: Trail-Making Test (TMT A and B)
timeFrame: From baseline to up to 6-8 weeks (post-intervention)
measure: Trail-Making Test (TMT A and B)
timeFrame: From baseline to 3-month follow-up
measure: Trail-Making Test (TMT A and B)
timeFrame: From baseline to 6-month follow-up
measure: Trail-Making Test (TMT A and B)
timeFrame: From baseline to 12-month follow-up
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to up to 6-8 weeks (post-intervention)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to 3-month follow-up
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to 6-month follow-up
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to 12-month follow-up
measure: The National Institutes of Health Stroke scale (NIHSS)
timeFrame: From baseline to 3-month, 6-month, and 12-month follow-ups
measure: modified Rankin Scale (MRS)
timeFrame: From baseline to 3-month, 6-month, and 12-month follow-ups
measure: Euro-QoL-5-Dimension (EQ-5D)
timeFrame: From baseline to 3-month, 6-month, and 12-month follow-ups
measure: Qualitative data
timeFrame: After intervention, an average of 2 months
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to 3-month follow-up
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to 6-month follow-up
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to 12-month follow-up
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University
name: Feng-Hang Chang, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.