Guided Training for People With Cognitive Impairment

NCT03225768 | Completed

• 1 other identifier: N201704046
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Objective: Investigators examined the feasibility of applying a participation-focused strategy training intervention to community-dwelling adults with cognitive impairments following stroke and brain injury and evaluated its potential effect on participation. Method: Participants with a diagnosis of stroke or brain injury participated in this single-group, repeated-measures study. Participants received 1\~2 sessions of strategy training intervention weekly for 8\~18 sessions. Outcome measures included the Participation Measure--3 Domains, 4 Dimensions (PM-3D4D), the Canadian Occupational Performance Measure (COPM), and feasibility indicators (participants' recruitment, retention, attendance, engagement, comprehension, satisfaction, and intervention adherence).

Conditions

TBI (Traumatic Brain Injury); Stroke; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

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

  The PM-3D4D is a 19-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community, rated on four dimensions: (1) 'Diversity of participation' (yes \[1\] vs. no \[0\]); (2) 'Frequency' (5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes \[1\] vs. no \[0\]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" \[1\] to "not difficult at all" \[4\]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.

  From baseline to 6 months following the completion of the intervention

• 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 intervention, up to 10 weeks

Secondary Outcomes (2)

• Activities

  From baseline to 6 months following the completion of the intervention

• Cognitive functioning

  From baseline to 6 months following the completion of the intervention

Study Arms (1)

Guided Training

EXPERIMENTAL

Behavioral: Guided Training

Interventions

Guided Training BEHAVIORAL

Guided training is an intervention strategy designed to help individuals identify barriers in their daily life and guide them to generate their own strategies to address these barriers. This intervention strategy is different from traditional direct skill training, in which rehabilitation practitioners are responsible for identifying their patients' challenges to perform activities and teaching them task-specific problem-solving strategies. Guided training has been applied in a variety of clinical populations, including individuals with stroke and TBI, and has demonstrated significant effect on improving independence with daily activities among persons with acute stroke-related cognitive impairments enrolled in inpatient rehabilitation.

Guided Training

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 20 years and older;
• had a first-time stroke or TBI;
• is able to understand Mandarin;
• has cognitive impairment (indicated by a score of 25 or less on the Montreal Cognitive Assessment (MoCA) or a score of 3 or less on the executive function subsection of MOCA);
• is able to provide informed consent.

You may not qualify if:

• Participants will be excluded if they:
• have severe aphasia
• have a pre-stroke diagnosis of dementia, current major depression disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFang Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Department of Taipei Medical University WanFang Hospital

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 21, 2017
• Study Start: September 1, 2017
• Primary Completion: November 18, 2018
• Study Completion: December 1, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

TW (1)