Occupational Performance Coaching for Stroke Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
University of Ottawa
Information provided by (Responsible Party):
Dorothy Kessler, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01800461
First received: February 22, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

Participation in valued activities following stroke is a recognized problem. Efficient and effective interventions to address this problem have not yet been established although the literature provides direction as to the needs of stroke survivors and important parts of interventions to address these needs. Occupational Performance Coaching (OPC) is an emerging approach to enabling occupational performance or participation in valued activities that includes these important parts of interventions. The primary goal of OPC is ability and satisfaction with participation in chosen activities, while promoting a client's ability to address future problems with participation. OPC has been successfully used with parents and their children in addressing problems with participation.

OPC has not been explored among adults who have experienced a stroke. For this study OPC-Stroke (OPC adapted for stroke survivors) will be tested to explore its potential effectiveness for increasing participation as well as how feasible and acceptable the research methods are. Sixteen participants who receive OPC-Stroke will be compared with sixteen who do not using measures of participation, goal achievement, well-being, self-efficacy and cognition. Those who receive OPC-Stroke will also be interviewed about their experience of the treatment.


Condition Intervention
Stroke
Other: OPC-Stroke
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Occupational Performance Coaching for Stroke Survivors: A Novel Patient-centered Intervention to Improve Participation in Personally Valued Activities

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Change in Reintegration to Normal Living Index score [ Time Frame: Baseline, average of 14 weeks, and 6 months ] [ Designated as safety issue: No ]
    Measurement of change in level of participation from baseline to immediately post-intervention(average of 14 weeks) and to 6 months.


Secondary Outcome Measures:
  • Change in Canadian Occupational Performance Measure scores [ Time Frame: Baseline, average of 14 weeks, and 6 months ] [ Designated as safety issue: No ]
  • Change in Hospital Anxiety and Depression Scale score [ Time Frame: Baseline, average of 14 weeks, and 6 months ] [ Designated as safety issue: No ]
    Measure of change in overall well-being

  • Change in Goals Systems Assessment Battery - Directive Functions Indicators score [ Time Frame: Baseline, average of 14 weeks, and 6 months ] [ Designated as safety issue: No ]
    Measure of change in goal self-efficacy

  • Change in Montreal Cognitive Assessment score [ Time Frame: Baseline, average of 14 weeks, and 6 months ] [ Designated as safety issue: No ]
    Measure of change in cognition


Other Outcome Measures:
  • Participant experience of intervention [ Time Frame: Average of 14 weeks for intervention group only ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-Stroke, Usual care
OPC-Stroke - 10 weekly sessions of goal setting followed by problem solving process
Other: OPC-Stroke Other: Usual care
Usual care
Usual care - Follow-up by physician and possible receipt of home care services
Other: Usual care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first hospitalization with a diagnosis of stroke (previous experience of adjustment to stroke may influence outcomes),
  • discharge from acute care hospital, inpatient rehabilitation or outpatient occupational therapy to a non-institutionalized setting,
  • FIM scores at rehabilitation discharge of at least 3 for expression, comprehension, memory and problem-solving (to ensure potential participants' ability to participate in coaching process) and
  • live within the City of Ottawa.

Exclusion Criteria:

  • Those discharged from acute or inpatient rehabilitation and are referred to outpatient stroke rehabilitation for occupational therapy will be excluded until they complete their outpatient occupational therapy (due to potential overlap of client goals while in outpatient occupational therapy)
  • have other degenerative neurological diagnoses (such as Parkinson's, Multiple Sclerosis) or
  • have a current major depressive or psychotic disorder.
  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: NCT01800461

Contacts
Contact: Dorothy Kessler, M.Sc. 613-562-6262 ext 1753 dkessler@bruyere.org

Locations
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Sub-Investigator: Mary Egan, PhD         
Bruyere Continuing Care Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Principal Investigator: Dorothy Kessler, PhD Candidate         
Sponsors and Collaborators
Ottawa Hospital Research Institute
University of Ottawa
Investigators
Principal Investigator: Dorothy Kessler, M. sc. PhD Candidate University of Ottawa
  More Information

No publications provided

Responsible Party: Dorothy Kessler, PhD Candidate, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01800461     History of Changes
Other Study ID Numbers: 20120844-01H
Study First Received: February 22, 2013
Last Updated: November 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Participation
Occupational Therapy
Valued Activities

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 10, 2014