NCT01800461

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

February 22, 2013

Last Update Submit

October 18, 2015

Conditions

Keywords

ParticipationOccupational TherapyValued Activities

Outcome Measures

Primary Outcomes (1)

  • Change in Reintegration to Normal Living Index score

    Measurement of change in level of participation from baseline to immediately post-intervention(average of 14 weeks) and to 6 months.

    Baseline, average of 14 weeks, and 6 months

Secondary Outcomes (4)

  • Change in Canadian Occupational Performance Measure scores

    Baseline, average of 14 weeks, and 6 months

  • Change in Hospital Anxiety and Depression Scale score

    Baseline, average of 14 weeks, and 6 months

  • Change in Goals Systems Assessment Battery - Directive Functions Indicators score

    Baseline, average of 14 weeks, and 6 months

  • Change in Montreal Cognitive Assessment score

    Baseline, average of 14 weeks, and 6 months

Other Outcomes (1)

  • Participant experience of intervention

    Average of 14 weeks for intervention group only

Study Arms (2)

OPC-Stroke, Usual care

EXPERIMENTAL

OPC-Stroke - 10 weekly sessions of goal setting followed by problem solving process

Other: OPC-StrokeOther: Usual care

Usual care

OTHER

Usual care - Follow-up by physician and possible receipt of home care services

Other: Usual care

Interventions

Occupational therapy coaching intervention

OPC-Stroke, Usual care

Usual community care

OPC-Stroke, Usual careUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Bruyere Continuing Care

Ottawa, Ontario, K1N 5C8, Canada

Location

Related Publications (2)

  • Kessler D, Egan M, Dubouloz CJ, McEwen S, Graham FP. Occupational Performance Coaching for Stroke Survivors: A Pilot Randomized Controlled Trial. Am J Occup Ther. 2017 May/Jun;71(3):7103190020p1-7103190020p7. doi: 10.5014/ajot.2017.024216.

  • Kessler DE, Egan MY, Dubouloz CJ, Graham FP, McEwen SE. Occupational performance coaching for stroke survivors: a pilot randomized controlled trial protocol. Can J Occup Ther. 2014 Dec;81(5):279-88. doi: 10.1177/0008417414545869.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dorothy Kessler, M. Sc.

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 27, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations