Adapting Daily Activity Performance Through Strategy Training

Attention Control Clinical Trial

— ADAPTS  

Official title:

Closing the Gap: Early Intervention for Cognitive Disability After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934621
• Other study ID #: PRO13070029
• Secondary ID: R01HD074693
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Control
• Strategy Training

Intervention

Behavioral:
• Strategy Training

• Attention Control

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Independence with Daily Activities	Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure)	Baseline to Month 6
Secondary	Change in Executive Functions	Moderate effect size of difference between groups in independence (measured with selected indices of the Delis-Kaplan Executive Function System)	Baseline to Month 6