- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654029
Patient Centred Communication Intervention (PCCI)
April 23, 2014 updated by: University Health Network, Toronto
The most frequent consequence of a stroke is a communication impairment.
When patients cannot articulate their needs, frustration and agitation are frequent responses, often resulting in poor optimization of post-stroke function.
Staff's lack of knowledge of communication strategies exacerbates the problem.
A key component of patient-centred care is the ability of staff to communicate in such a way that allows them to understand the patient's needs.
Members of our team developed the patient-centred communication intervention (PCCI) targeting registered and unregulated staff caring for complex continuing care (CCC) patients with communication impairments post stroke.
The purpose of the study is to examine if the PCCI results in improved patients' quality of life and in improved staff attitudes and skills in caring for patients with communication impairments.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M6K 2R7
- Toronto Rehabilitation Institute, E.W. Bickle Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Patients:
Inclusion Criteria
- diagnosis of stroke related to cerebral infarct
- presence of a communication impairment
- ability to speak and understand English before the stroke
- ability to consent
Exclusion Criteria:
- global aphasia or severe Wernicke's aphasia
Staff:
Inclusion Criteria
- directly involved in providing care
- employed full or part-time
- ability to consent
- ability to speak and write English
- work with patients who have communication impairments
Exclusion Criteria
- unwilling to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group receiving usual care
Usual care consists of speech language therapy for some patients.
Most care is focused on swallowing assessments.
|
|
|
Experimental: PCCI Intervention
The Patient-Centred Communication Intervention consists of 1) development of a communication care plan; 2)a workshop for staff focused on communication and behavioural management strategies,: and 3) implementing a staff support system.
|
The intervention consists of three parts: 1) development of individualized communication care plans; 2) staff attendance at a workshop focused on communication and behavioral management strategies; and 3) implementation of a staff support system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke and Aphasia Quality of Life (SAQOL)
Time Frame: Change in SAQOL from baseline to 1 month and from baseline to 3 months
|
The SAQOL is a 39-item tool designed to measure health-related quality of life in patients post-stroke with aphasia.
|
Change in SAQOL from baseline to 1 month and from baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication-Impairment Questionnaire (CIQ)
Time Frame: Change in CIQ from baseline to 1 month and from baseline to 3 months
|
The Communication Impairment Questionnaire is an 8-item self-report scale.
It is used to measure the attitudes of nurses toward patients with communication impairments.
|
Change in CIQ from baseline to 1 month and from baseline to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Katherine S McGilton, RN, PhD, University Health Network, Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
July 20, 2012
First Submitted That Met QC Criteria
July 27, 2012
First Posted (Estimate)
July 31, 2012
Study Record Updates
Last Update Posted (Estimate)
April 24, 2014
Last Update Submitted That Met QC Criteria
April 23, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCCI 93790
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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