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SMARTease Trial: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke (SMARTease)

This study has been terminated.
(Poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407081
First Posted: August 1, 2011
Last Update Posted: August 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Gail Eskes, Capital District Health Authority, Canada
  Purpose
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.

Condition Intervention Phase
Cognitive Impairment Stroke Behavioral: Telerehabilitation Cognitive Strategy Training Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMARTease Trial - Turning SMART Goals Into Smart Actions: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke

Resource links provided by NLM:


Further study details as provided by Gail Eskes, Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Change in functioning [ 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 Outcome Measures:
  • Intervention modifiers [ Time Frame: measured at baseline and weekly until end of study at week 18 ]
    Additional secondary analyses will also investigate variables that could modify the effects of the interventions, including cognitive profile, stroke severity and location of lesion, co-morbid conditions, type of functional goal and current environmental factors.

  • Feasibility [ Time Frame: measured at end of 16 week study ]
    Feasibility as measured by rates of subject recruitment, retention, and compliance with protocol

  • Feasibility-Coach adherence [ Time Frame: measured at weekly intervals ]
    Feasibility of coach adherence to therapy protocols will be assessed weekly through review of adherence to scripts and completeness of data collection


Estimated Enrollment: 10
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training
telerehabilitation cognitive strategy training
Behavioral: Telerehabilitation Cognitive Strategy Training
The strategy intervention is a 16-week program during which a trained rehabilitation coach speaks by telephone to the stroke participant and their caregiver twice a week (one approximately 45-minute 'training' call and one approximately 15-minute 'update' call). Rehabilitation discussions during the training calls will follow a detailed protocol and focus each week on the stroke education and cognitive strategy training information provided in each section of the manual provided to the participants.
Other Name: cognitive rehabilitation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407081


Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Gail A Eskes, Ph.D. Capital District Health Authority, Nova Scotia, Canada
  More Information

Responsible Party: Gail Eskes, Dr. Gail Eskes, Professor, Department of Psychiatry, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01407081     History of Changes
Other Study ID Numbers: CDHA-RS/2012-040
First Submitted: June 23, 2011
First Posted: August 1, 2011
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by Gail Eskes, Capital District Health Authority, Canada:
cognitive rehabilitation
SMART goals
telehealth

Additional relevant MeSH terms:
Stroke
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders