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Guided Training for People With Cognitive Impairment (GTPCI)

Primary Purpose

TBI (Traumatic Brain Injury), Stroke, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Guided Training
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI (Traumatic Brain Injury)

Eligibility Criteria

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

Inclusion Criteria:

The inclusion criteria include that the participant:

  1. ages 20 years and older;
  2. had a first-time stroke or TBI;
  3. is able to understand Mandarin;
  4. 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);
  5. is able to provide informed consent.

Exclusion Criteria:

Participants will be excluded if they:

  1. have severe aphasia
  2. 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.

Sites / Locations

  • WanFang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guided Training

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Activities
Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
Cognitive functioning
Wisconsin Card Sorting Task (WCST)

Full Information

First Posted
June 22, 2017
Last Updated
September 30, 2019
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03225768
Brief Title
Guided Training for People With Cognitive Impairment
Acronym
GTPCI
Official Title
Adopting Guided Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke and Traumatic Brain Injury: A Feasibility Study (GTPCI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 18, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

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

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 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).
Detailed Description
Method Design A single-group, repeated-measures design was adopted for this study. All participants received the participation-focused strategy training intervention and the assessments at baseline (T1) and at post-intervention (T2). The study protocols were approved by the university institutional review board. Intervention The intervention protocols were developed based on the strategy training guidelines developed by Skidmore et al. Three trained research occupational therapists delivered the intervention to participants in addition to their regular outpatient rehabilitation care. The following standardized procedures were followed. First, the therapists asked the participants to identify three participation goals that they perceived important to them. Next, the participants were asked to identify barriers to their performance, and according to which the therapists taught the participants the "Goal-Plan-Do-Check" strategy, which involves (1) setting a goal to address the barriers, (2) developing a plan to address the goal, (3) doing the plan, and (4) checking if the plan worked or required revising. This procedure repeated iteratively until the participants' goal was met, and the next goal could be moved on to. At the end of each session, the therapists prompted the participants to identify the principles they learned during the session and encouraged the participants to apply these principles in the next session. Each participant received 1~2 intervention sessions per week for a total of 10~20 intervention sessions (or until their goals were achieved) from trained research therapists. Each session lasted for 45~60 minutes. All intervention sessions were recorded and rated for fidelity by research staff. Measures Background Characteristics. Demographic variables (e.g., age and gender) were collected through a questionnaire developed by the research team at baseline assessment. Clinical variables (e.g., diagnosis and time since injury/illness) were retrieved from participants' medical charts. Feasibility Indicators. Investigators assessed feasibility by examining (1) the number of participants recruited and retained; (2) the number of intervention sessions that participants attended; (3) participants' engagement in the intervention sessions (assessed by the research therapists using the Pittsburgh Rehabilitation Participation Scale, measured on a 6-point scale: 1: no engagement to 6: excellent engagement); (4) participants' comprehension of the intervention sessions (assessed by a 3-point scale: 1: minimal understanding to 3: good understanding); (5) participants' satisfaction with the intervention (assessed by the Client Satisfaction Questionnaire, a 8-item questionnaire, with total scores 8~32 (0~23: poor to fair satisfaction; 24~32: moderate to high satisfaction); and (6) the intervention adherence (measured by the Strategy Training Fidelity Checklist, for which an independent rater randomly selected 20% of sessions to rate the research therapists' adherence to the principles in the intervention protocol (yes, no) and competence in execution (inadequate, adequate, exceptional).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury), Stroke, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Guided Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
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.
Time Frame
From baseline to 6 months following the completion of the intervention
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 intervention, up to 10 weeks
Secondary Outcome Measure Information:
Title
Activities
Description
Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
Time Frame
From baseline to 6 months following the completion of the intervention
Title
Cognitive functioning
Description
Wisconsin Card Sorting Task (WCST)
Time Frame
From baseline to 6 months following the completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The inclusion criteria include that the participant: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
WanFang Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

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Guided Training for People With Cognitive Impairment

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