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

This study has been terminated.
(Poor recruitment)
Sponsor:
Collaborators:
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Gail Eskes, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01407081
First received: June 23, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Cognitive Impairment
Stroke
Behavioral: Telerehabilitation Cognitive Strategy Training
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SMARTease Trial - Turning SMART Goals Into Smart Actions: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Change in functioning [ Time Frame: Measured at baseline and week 18 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Intervention modifiers [ Time Frame: measured at baseline and weekly until end of study at week 18 ] [ Designated as safety issue: No ]
    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.

  • Feasibility [ Time Frame: measured at end of 16 week study ] [ Designated as safety issue: No ]
    Feasibility as measured by rates of subject recruitment, retention, and compliance with protocol

  • Feasibility-Coach adherence [ Time Frame: measured at weekly intervals ] [ Designated as safety issue: No ]
    Feasibility of coach adherence to therapy protocols will be assessed weekly through review of adherence to scripts and completeness of data collection


Estimated Enrollment: 10
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training
telerehabilitation cognitive strategy training
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.
Other Name: cognitive rehabilitation

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407081

Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Capital District Health Authority, Canada
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Gail A Eskes, Ph.D. Capital District Health Authority, Nova Scotia, Canada
  More Information

No publications provided

Responsible Party: Gail Eskes, Dr. Gail Eskes, Professor, Department of Psychiatry, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01407081     History of Changes
Other Study ID Numbers: CDHA-RS/2012-040
Study First Received: June 23, 2011
Last Updated: July 31, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
cognitive rehabilitation
SMART goals
telehealth

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cognition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014