Clinical trial NCT01407081: SMARTease Trial: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke
Official title: SMARTease Trial - Turning SMART Goals Into Smart Actions: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Impairment
Stroke
Keywords: cognitive rehabilitation
SMART goals
telehealth
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-08-01
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in functioning on goal attainment scaling
timeFrame: Measured at baseline and week 18
Secondary outcomes:
measure: Intervention modifiers
timeFrame: measured at baseline and weekly until end of study at week 18
measure: Feasibility of recruitment, retention, compliance
timeFrame: measured at end of 16 week study
measure: Feasibility-Coach adherence
timeFrame: measured at weekly intervals
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Capital District Health Authority, Nova Scotia, Canada
name: Gail A Eskes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: