Clinical trial NCT03225768: Guided Training for People With Cognitive Impairment
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
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Stroke
Cognitive Impairment
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to 6 months following the completion of the intervention
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: From the first session to the last session of the intervention, up to 10 weeks
Secondary outcomes:
measure: Activities
timeFrame: From baseline to 6 months following the completion of the intervention
measure: Cognitive functioning
timeFrame: From baseline to 6 months following the completion of the intervention
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
References: