Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

Taipei Medical University

Status: Active, not recruiting

Conditions: Cognitive Impairment; Stroke

Treatments: Behavioral: Strategy Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03792061

N201804055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups

Strategy Training

Experimental group

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.

Treatment:

Behavioral: Strategy Training

Reflective listening

No Intervention group

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.