SMARTease Trial: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke (SMARTease)
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|ClinicalTrials.gov Identifier: NCT01407081|
Recruitment Status : Terminated (Poor recruitment)
First Posted : August 1, 2011
Last Update Posted : August 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment Stroke||Behavioral: Telerehabilitation Cognitive Strategy Training||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SMARTease Trial - Turning SMART Goals Into Smart Actions: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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
- 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).
- 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
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
|Canada, Nova Scotia|
|Capital District Health Authority|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Principal Investigator:||Gail A Eskes, Ph.D.||Capital District Health Authority, Nova Scotia, Canada|