Adapting Daily Activity Performance Through Strategy Training (ADAPTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01934621
First received: August 29, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Strategy Training
Attention Control
Behavioral: Strategy Training
Behavioral: Attention Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Closing the Gap: Early Intervention for Cognitive Disability After Stroke

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Functional Independence Measure [ Time Frame: month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delis-Kaplan Executive Function System [ Time Frame: month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01934621     History of Changes
Other Study ID Numbers: PRO13070029, R01HD074693
Study First Received: August 29, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board
United States: Data Safety Monitoring Committee

Keywords provided by University of Pittsburgh:
Stroke
Rehabilitation
Cognition
Disability

ClinicalTrials.gov processed this record on September 16, 2014