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Guided Training for People With Cognitive Impairment (GTPCI)

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ClinicalTrials.gov Identifier: NCT03225768
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Yen-Nung Lin, Taipei Medical University WanFang Hospital

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).


Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Stroke Cognitive Impairment Behavioral: Guided Training Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adopting Guided Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke and Traumatic Brain Injury: A Feasibility Study (GTPCI)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : March 18, 2019
Estimated Study Completion Date : May 18, 2019

Arm Intervention/treatment
Experimental: Guided Training Behavioral: Guided Training
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 Measures :
  1. Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D) [ Time Frame: From baseline to 6 months following the completion of the intervention ]
    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.

  2. Canadian Occupational Performance Measure (COPM) [ Time Frame: From the first session to the last session of the intervention, up to 10 weeks ]
    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 :
  1. Activities [ Time Frame: From baseline to 6 months following the completion of the intervention ]
    Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms

  2. Cognitive functioning [ Time Frame: From baseline to 6 months following the completion of the intervention ]
    Wisconsin Card Sorting Task (WCST)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225768


Locations
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Taiwan
WanFang Hospital Recruiting
New Taipei City, Taiwan
Contact: Yen-Nung Lin, MD, MS    0970746879    semitune@gmail.com   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital

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Responsible Party: Yen-Nung Lin, Director of Rehabilitation Department of Taipei Medical University WanFang Hospital, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03225768     History of Changes
Other Study ID Numbers: N201704046
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Stroke
Cognitive Dysfunction
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cognition Disorders
Neurocognitive Disorders
Mental Disorders