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Adapting Daily Activity Performance Through Strategy Training

NCT ID: NCT01934621

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Strategy Training Attention Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Strategy Training

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

Interventions

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Strategy Training

Intervention Type BEHAVIORAL

Attention Control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth R. Skidmore, PhD, OTR/L

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth R Skidmore, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29552996 (View on PubMed)

Other Identifiers

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R01HD074693

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO13070029

Identifier Type: -

Identifier Source: org_study_id