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

NCT ID: NCT01407081

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-04-30

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.

Conditions

Cognitive Impairment; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Training

telerehabilitation cognitive strategy training

Group Type: EXPERIMENTAL

Telerehabilitation Cognitive Strategy Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

cognitive rehabilitation

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).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IWK Health Centre

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Gail Eskes

Dr. Gail Eskes, Professor, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gail A Eskes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Capital District Health Authority, Nova Scotia, Canada

Locations

Capital District Health Authority

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CDHA-RS/2012-040

Identifier Type: -

Identifier Source: org_study_id