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Clinical Trials/NCT01407081
NCT01407081
Terminated
Not Applicable

SMARTease Trial - Turning SMART Goals Into Smart Actions: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke

Nova Scotia Health Authority1 site in 1 country11 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Nova Scotia Health Authority
Enrollment
11
Locations
1
Primary Endpoint
Change in functioning on goal attainment scaling
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to provide evidence for the feasibility and initial effectiveness of a manualized, telephone-based (telehealth) approach to the delivery of cognitive interventions (SMARTease) targeted to improve cognitive performance in daily activities after stroke.

Detailed Description

An initial brief screening interview will be completed with the potential participant by telephone to determine whether or not the individual meets the criteria for the study. In an initial onsite visit, informed consent will be obtained from both the stroke survivor and their study partner and baseline evaluations will be completed with the stroke survivor, including a baseline cognitive assessment and setting goals to work on during the study period. Then the introductory section of the study Handbook (Making the Most of Your Memory) which includes procedural information on the Stroke Help Program will be reviewed with the stroke survivor and study partner. A study Handbook and a large button speaker phone will be provided to the stroke survivor/partner pair to ensure that both members of the participant-caregiver team can listen to the rehabilitation coach without having to be concerned with holding a handset (an action that may be difficult for some stroke survivors). Telephone contact by the rehabilitation coach will be organized and the 16-week Stroke Help Cognitive Strategy Training Intervention will proceed. In general the topics or strategies to be discussed will be used to achieve one or more of the following rehabilitation strategies: 1) Understanding cognitive deficits that may result from stroke; 2). Reinforcing, strengthening or re-establishing previously learned patterns of behavior; 3) Establishing new patterns of compensatory mechanisms; 4) Enabling persons to adapt to their cognitive disability. Following the 16-week Cognitive Strategy Training Intervention participants will have an on-site visit to provide qualitative and quantitative data related to the feasibility and efficacy of the program.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
April 2012
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gail Eskes

Dr. Gail Eskes, Professor, Department of Psychiatry

Nova Scotia Health Authority

Eligibility Criteria

Inclusion Criteria

  • history of one or more strokes;
  • living in the community;
  • subjective concerns about cognitive function;
  • ability to give informed consent;
  • fluent in written and spoken English.

Exclusion Criteria

  • unstable medical conditions or a co-morbid neurological disorder that could additionally impact cognitive or daily function, such as Parkinson's disease or Multiple Sclerosis;
  • no available caregiver or significant other willing to participate in approximately one hour of telephone contact per week with coach and stroke survivor;
  • current symptoms of severe depression (Geriatric Depression Scale\>20), global aphasia, or dementia (determined by baseline testing).

Outcomes

Primary Outcomes

Change in functioning on goal attainment scaling

Time Frame: Measured at baseline and week 18

estimating within subject effect sizes for the treated group based on changes in measures at the level of impairment (self and other-reported cognitive performance), activity (achievement of activity goals and everyday cognitive performance) and participation/quality of life (self-report measures of reintegration to normal living, quality of life, caregiver burden).

Secondary Outcomes

  • Intervention modifiers(measured at baseline and weekly until end of study at week 18)
  • Feasibility of recruitment, retention, compliance(measured at end of 16 week study)
  • Feasibility-Coach adherence(measured at weekly intervals)

Study Sites (1)

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