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

Not Applicable

Terminated

• Conditions: Stroke; Cognitive Impairment
• Interventions: Behavioral: Telerehabilitation Cognitive Strategy Training

• Registration Number: NCT01407081
• Lead Sponsor: Nova Scotia Health Authority

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.

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-07-29
• Study Start: 2011-08
• Study First Posted: 2011-08-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training	Telerehabilitation Cognitive Strategy Training	telerehabilitation cognitive strategy training

Primary Outcome Measures

Name	Time	Method
Change in functioning on goal attainment scaling	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

Name	Time	Method
Intervention modifiers	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 of recruitment, retention, compliance	measured at end of 16 week study	Rates of subject recruitment, retention, and compliance with protocol
Feasibility-Coach adherence	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

Trial Locations

Locations (1)

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada