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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01407081
Acronym
SMARTease
Enrollment
11
Registered
2011-08-01
Start date
2011-08-31
Completion date
2012-04-30
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Stroke

Keywords

cognitive rehabilitation, SMART goals, telehealth

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.

Interventions

BEHAVIORALTelerehabilitation 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.

Sponsors

IWK Health Centre
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in functioning on goal attainment scalingMeasured at baseline and week 18estimating 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

MeasureTime frameDescription
Intervention modifiersmeasured at baseline and weekly until end of study at week 18Additional 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, compliancemeasured at end of 16 week studyRates of subject recruitment, retention, and compliance with protocol
Feasibility-Coach adherencemeasured at weekly intervalsFeasibility of coach adherence to therapy protocols will be assessed weekly through review of adherence to scripts and completeness of data collection

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026