NCT01934621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

4.5 years

First QC Date

August 29, 2013

Last Update Submit

November 3, 2020

Conditions

Strategy TrainingAttention Control

Keywords

StrokeRehabilitationCognitionDisability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Executive Functions

    Baseline to Month 6

Study Arms (2)

Strategy Training

EXPERIMENTAL

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

Attention Control

PLACEBO COMPARATOR

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

Interventions

Strategy TrainingBEHAVIORAL
Strategy Training
Attention ControlBEHAVIORAL
Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.

    PMID: 29552996DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Elizabeth R Skidmore, PhD, OTR/L

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 4, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2018

Study Completion

September 1, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

US(1)