AphasiaPCCINCT01654029
Patient Centred Communication Intervention
A study testing Patient-Centred Communication Intervention in people with Aphasia and Stroke, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Patient-Centred Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of stroke related to cerebral infarct
- presence of a communication impairment
- ability to speak and understand English before the stroke
- ability to consent
- directly involved in providing care
- employed full or part-time
Show all 9Show fewer
- ability to consent
- ability to speak and write English
- work with patients who have communication impairments
Who cannot join
- global aphasia or severe Wernicke's aphasia
- Staff:
- unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute, E.W. Bickle Centre
Toronto, Ontario, M6K 2R7
About this study
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.
- Being tested
- Patient-Centred Communication Intervention
- Keywords
- Stroke, Communication impairments, Nurse-patient communication, Patient-centred care
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centred Communication InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group receiving usual care | No intervention | Usual care consists of speech language therapy for some patients. Most care is focused on swallowing assessments. |
| PCCI Intervention | Experimental | 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. Receives: Behavioral: Patient-Centred Communication Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke and Aphasia Quality of Life (SAQOL)
The SAQOL is a 39-item tool designed to measure health-related quality of life in patients post-stroke with aphasia.
Measured: Change in SAQOL from baseline to 1 month and from baseline to 3 months
Secondary outcomes (1)
Communication-Impairment Questionnaire (CIQ)
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.
Measured: Change in CIQ from baseline to 1 month and from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Katherine S McGilton, RN, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654029
- Sponsor's protocol ID
- PCCI 93790
- Acronym
- PCCI
- Status last verified
- Apr 2014
- First submitted
- 20 Jul 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McGilton KS, Sorin-Peters R, Sidani S, Boscart V, Fox M, Rochon E. Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care. BMC Geriatr. 2012 Oct 11;12:61. doi: 10.1186/1471-2318-12-61.
PubMed 23050517
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centred Communication Intervention
- ClinicalTrials.gov ID
- NCT01654029
- Acronym / sponsor ID
- PCCI / PCCI 93790
- Keywords
- Stroke, Communication impairments, Nurse-patient communication, Patient-centred care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group receiving usual care | No intervention | –Usual care consists of speech language therapy for some patients. Most care is focused on swallowing assessments. |
| PCCI Intervention | Experimental | Behavioral: Patient-Centred Communication InterventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- diagnosis of stroke related to cerebral infarct
- presence of a communication impairment
- ability to speak and understand English before the stroke
- ability to consent
- directly involved in providing care
Key exclusion criteria (3 listed)
- global aphasia or severe Wernicke's aphasia
- unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Centred Communication InterventionThe 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. | Behavioural | PCCI Intervention |
Primary outcome
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.
1 secondary outcome
Communication-Impairment Questionnaire (CIQ)
Time frame: Change in CIQ from baseline to 1 month and from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 23050517McGilton KS, Sorin-Peters R, Sidani S, Boscart V, Fox M, Rochon E. Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care. BMC Geriatr. 2012 Oct 11;12:61. doi: 10.1186/1471-2318-12-61.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine S McGilton, RN, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centred Communication Intervention in people with Aphasia and Stroke, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke and Aphasia Quality of Life (SAQOL) (time frame: Change in SAQOL from baseline to 1 month and from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01654029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.