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Adapting Daily Activity Performance Through Strategy Training (ADAPTS)

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ClinicalTrials.gov Identifier: NCT01934621
Recruitment Status : Recruiting
First Posted : September 4, 2013
Last Update Posted : August 17, 2017
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

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. 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.

Condition or disease Intervention/treatment
Strategy Training Attention Control Behavioral: Strategy Training Behavioral: Attention Control

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Closing the Gap: Early Intervention for Cognitive Disability After Stroke
Study Start Date : November 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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.
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.
Behavioral: Attention Control



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01934621


Contacts
Contact: Elizabeth R Skidmore, PhD, OTR/L (412) 383-6617 skidmore@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Elizabeth R Skidmore, PhD, OTR/L    412-383-6617    skidmore@pitt.edu   
Contact: Laura F Waterstram, MOT, OTR/L    (412) 383-6752    lfw11@pitt.edu   
Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L         
Sponsors and Collaborators
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L University of Pittsburgh

Responsible Party: Elizabeth R. Skidmore, PhD, OTR/L, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01934621     History of Changes
Other Study ID Numbers: PRO13070029
R01HD074693 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh:
Stroke
Rehabilitation
Cognition
Disability