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

Stroke Clinical Trial

— SMARTease  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01407081
• Other study ID #: CDHA-RS/2012-040
• Status: Terminated
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Impairment
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Canadian Institutes of Health Research (CIHR), IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functioning on goal attainment scaling	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).	Measured at baseline and week 18
Secondary	Intervention modifiers	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.	measured at baseline and weekly until end of study at week 18
Secondary	Feasibility of recruitment, retention, compliance	Rates of subject recruitment, retention, and compliance with protocol	measured at end of 16 week study
Secondary	Feasibility-Coach adherence	Feasibility of coach adherence to therapy protocols will be assessed weekly through review of adherence to scripts and completeness of data collection	measured at weekly intervals