Directed Training, Guided Training
Conditions
Keywords
Stroke, Rehabilitation, Cognition, Disability, Intervention
Brief summary
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.
Interventions
BEHAVIORALGuided Training
BEHAVIORALDirected Training
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary diagnosis of acute stroke * admission to acute inpatient rehabilitation * impairment in cognitive functions (as indicated by 14-item Executive Interview ≥ 3)
Exclusion criteria
* diagnosis of dementia in the medical record * inability to follow two-step commands 80% of the time * severe aphasia (score of 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale) * current untreated major depressive, bipolar, or psychotic disorder (PRIME-MD) * drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Baseline, rehab discharge, month 3, month 6, month 12 | Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: August 2012 to December 2014. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.
Pre-assignment details
Excluded (n=27) * Insufficient cognitive impairment (n=6) * Mood/psychotic disorder (n=14) * Drug/alcohol abuse (n=3) * Change in medical status (n=1) * Pre-morbid cognitive impairment (n=1) * Short Length of Stay (n=2) Withdrew prior to randomization (n=7) * Changed mind (n=4) * Discharged (n=3)
Participants by arm
| Arm | Count |
|---|---|
| Guided Training Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training | 21 |
| Directed Training Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Directed Training | Guided Training | Total |
|---|---|---|---|
| Age, Continuous | 66.73 years STANDARD_DEVIATION 14.25 | 65.86 years STANDARD_DEVIATION 11.67 | 66.30 years STANDARD_DEVIATION 12.91 |
| Cognitive status, EXIT | 10.86 units on a scale STANDARD_DEVIATION 5.14 | 12.38 units on a scale STANDARD_DEVIATION 5.11 | 11.60 units on a scale STANDARD_DEVIATION 5.12 |
| Functional Independence Measure | 67.32 units on a scale STANDARD_DEVIATION 18.33 | 67.33 units on a scale STANDARD_DEVIATION 14.72 | 67.33 units on a scale STANDARD_DEVIATION 16.47 |
| Hemisphere Left | 13 participants | 10 participants | 23 participants |
| Hemisphere Right | 9 participants | 11 participants | 20 participants |
| Race/Ethnicity, Customized African American | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 21 participants | 20 participants | 41 participants |
| Region of Enrollment United States | 22 participants | 21 participants | 43 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
| Stroke onset | 22.36 days STANDARD_DEVIATION 30.97 | 16.29 days STANDARD_DEVIATION 18.24 | 19.40 days STANDARD_DEVIATION 25.46 |
| Stroke severity, NIHSS | 7.86 units on a scale STANDARD_DEVIATION 5.1 | 7.00 units on a scale STANDARD_DEVIATION 3.9 | 7.44 units on a scale STANDARD_DEVIATION 4.52 |
| Stroke type hemorrhagic | 8 participants | 7 participants | 15 participants |
| Stroke type ischemic | 14 participants | 14 participants | 28 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.
Time frame: Baseline, rehab discharge, month 3, month 6, month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guided Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Baseline Scores | 67.33 units on a scale | Standard Error 3.21 |
| Guided Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 6 Scores | 107.68 units on a scale | Standard Error 3.45 |
| Guided Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 3 Scores | 105.32 units on a scale | Standard Error 4.94 |
| Guided Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 12 Scores | 108.47 units on a scale | Standard Error 4.34 |
| Guided Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Discharge Scores | 86.86 units on a scale | Standard Error 3.08 |
| Directed Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 12 Scores | 100.25 units on a scale | Standard Error 5.12 |
| Directed Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Discharge Scores | 89.05 units on a scale | Standard Error 4.41 |
| Directed Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Baseline Scores | 67.32 units on a scale | Standard Error 3.91 |
| Directed Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 3 Scores | 102.55 units on a scale | Standard Error 5.41 |
| Directed Training | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 6 Scores | 100.52 units on a scale | Standard Error 5.35 |
Comparison: All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.p-value: <0.00195% CI: [-0.12, 1.19]Linear mixed models