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Adapting Daily Activity Performance Through Strategy Training (ADAPTS)

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ClinicalTrials.gov Identifier: NCT01934621
Recruitment Status : Active, not recruiting
First Posted : September 4, 2013
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh

August 29, 2013
September 4, 2013
October 8, 2018
November 2013
May 2018   (Final data collection date for primary outcome measure)
Change in Independence with Daily Activities [ Time Frame: Baseline to Month 6 ]
Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure)
Functional Independence Measure [ Time Frame: month 6 ]
Complete list of historical versions of study NCT01934621 on ClinicalTrials.gov Archive Site
Change in Executive Functions [ Time Frame: Baseline to Month 6 ]
Moderate effect size of difference between groups in independence (measured with selected indices of the Delis-Kaplan Executive Function System)
Delis-Kaplan Executive Function System [ Time Frame: month 6 ]
Not Provided
Not Provided
 
Adapting Daily Activity Performance Through Strategy Training
Closing the Gap: Early Intervention for Cognitive Disability After Stroke
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Strategy Training
  • Attention Control
  • Behavioral: Strategy Training
  • Behavioral: Attention Control
  • Experimental: Strategy Training
    Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Participants use printed workbooks to learn and apply this method.
    Intervention: Behavioral: Strategy Training
  • Placebo Comparator: Attention Control
    The attention control intervention will control for the non-specific effects of strategy training. The therapists will administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. In lieu of the strategy training workbook materials, participants will complete a daily journal, and discuss their entries during attention control sessions.
    Intervention: Behavioral: Attention Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
128
120
May 2019
May 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary diagnosis of acute stroke
  • admission to acute inpatient rehabilitation
  • impairment in higher order cognitive functions (EXIT-14 ≥ 3)

Exclusion Criteria:

  • pre-stroke diagnosis of dementia in the medical record
  • inability to follow two- step commands 80% of the time
  • severe aphasia (BDAE ≤ 1)
  • current major depressive, bipolar, or psychotic disorder
  • drug or alcohol abuse within 3 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01934621
PRO13070029
R01HD074693 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L University of Pittsburgh
University of Pittsburgh
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP