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

NCT01407081 | Terminated

• 1 other identifier: CDHA-RS/2012-040
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Stroke

Keywords

cognitive rehabilitation; SMART goals; telehealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intervention modifiers

  measured at baseline and weekly until end of study at week 18

• Feasibility of recruitment, retention, compliance

  measured at end of 16 week study

• Feasibility-Coach adherence

  measured at weekly intervals

Study Arms (1)

Training

EXPERIMENTAL

telerehabilitation cognitive strategy training

Behavioral: Telerehabilitation Cognitive Strategy Training

Interventions

Telerehabilitation Cognitive Strategy Training BEHAVIORAL

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.

Also known as: cognitive rehabilitation

Training

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• IWK Health Centre: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gail A Eskes, Ph.D.

  Capital District Health Authority, Nova Scotia, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gail Eskes, Professor, Department of Psychiatry

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: August 1, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CA (1)