Thin Liquid DysphagiaPhase 1NCT00616512
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
A Phase 1 study testing GF Strong Water Protocol in people with Thin Liquid Dysphagia, run by University of British Columbia at 1 site in Canada.
Trial summary
The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol. Water Protocols have been shown to improve client satisfaction, and hydration. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thin Liquid Dysphagia
- What is being tested?
- GF Strong Water Protocol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jun 2011
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential participants in this study will include all clients aged 19 years and older who are admitted to GF Strong Acquired Brain Injury (ABI) and Neruomusculoskeletal (NMS) and Adolescent and Young Adult (AYA) programs and who have thin liquid dysphagia resulting from a neurological diagnosis. The thin liquid dysphagia will be confirmed by a Modified Barium Swallow conducted by a certified speech-language pathologist. Potential participants must be proficient in English in order to complete the questionnaires and capable of understanding the consent form.
Who cannot join
- Clients who present with the following will be excluded: active pneumonia, acute or unstable medical condition, surgery where coughing might rip stitches or cause pain or discomfort, oral dental bacteria or infection that cannot be controlled, poor oral hygiene that cannot be improved with routine care, excessive or uncomfortable coughing during or after intake, severe or uncontrolled GERD, immunosuppressed, or decline participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project
The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol. Water Protocols have been shown to improve client satisfaction, and hydration. We wish to assess this in a randomized, controlled fashion, and this is a pilot project to determine feasibility.
Read the detailed description
GF Strong water protocol will be used with the study subjects. Control subjects will not receive water protocol. Pre and post measures will include SWAL-QOL, client satisfaction, water and thickened fluid intake, and monitoring for adverse events.
- Conditions
- Thin Liquid Dysphagia
- Being tested
- GF Strong Water Protocol
- Keywords
- Water, oral care, oral hygiene, dysphagia, thin liquid dysphagia, thickened liquids
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GF Strong Water ProtocolProcedure or surgery
The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol Receives: Procedure: GF Strong Water Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Measured: Information not available
Secondary outcomes (1)
Fluid intake, client satisfaction, quality of life, adverse events
Measured: Information not available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Liquid DysphagiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- B.C. Rehabilitation Foundation
- Investigators
- Caren Carlaw, MA, Principal investigator, University of British ColumbiaHeather Finlayson, MD, FRCPC, Study director, University of British ColumbiaKathleen Beggs, Bse RDN, Study director, University of British ColumbiaAndrew Travlos, MBBCh FRCPC, Study director, University of British ColumbiaDawn Coney, RN (CRN), Study director, University of British ColumbiaTiffany Visser, MS, Study director, University of British ColumbiaCaroline Marcoux, MS, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616512
- Sponsor's protocol ID
- H07-02582
- Status last verified
- Jun 2011
- First submitted
- 4 Feb 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project
- ClinicalTrials.gov ID
- NCT00616512
- Acronym / sponsor ID
- H07-02582
- Conditions
- Thin Liquid Dysphagia
- Keywords
- Water, oral care, oral hygiene, dysphagia, thin liquid dysphagia, thickened liquids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- B.C. Rehabilitation Foundation
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Feb 2008 (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 Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol. Water Protocols have been shown to improve client satisfaction, and hydration. We wish to assess this in a randomized, controlled fashion, and this is a pilot project to determine feasibility.
Detailed description
GF Strong water protocol will be used with the study subjects. Control subjects will not receive water protocol. Pre and post measures will include SWAL-QOL, client satisfaction, water and thickened fluid intake, and monitoring for adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: GF Strong Water ProtocolGF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Potential participants in this study will include all clients aged 19 years and older who are admitted to GF Strong Acquired Brain Injury (ABI) and Neruomusculoskeletal (NMS) and Adolescent and Young Adult (AYA) programs and who have thin liquid dysphagia resulting from a neurological diagnosis. The thin liquid dysphagia will be confirmed by a Modified Barium Swallow conducted by a certified speech-language pathologist. Potential participants must be proficient in English in order to complete the questionnaires and capable of understanding the consent form.
Key exclusion criteria (1 listed)
- Clients who present with the following will be excluded: active pneumonia, acute or unstable medical condition, surgery where coughing might rip stitches or cause pain or discomfort, oral dental bacteria or infection that cannot be controlled, poor oral hygiene that cannot be improved with routine care, excessive or uncomfortable coughing during or after intake, severe or uncontrolled GERD, immunosuppressed, or decline participation.
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 |
|---|---|---|
| GF Strong Water ProtocolThe Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol. | Procedure or surgery | 1 |
Primary outcome
Feasibility
Time frame: Information not available
1 secondary outcome
Fluid intake, client satisfaction, quality of life, adverse events
Time frame: Information not available
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 23 Jun 2011.
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.
Caren Carlaw, MA principal investigator
University of British Columbia
Heather Finlayson, MD, FRCPC study director
University of British Columbia
Kathleen Beggs, Bse RDN study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GF Strong Water Protocol in people with Thin Liquid Dysphagia, run by University of British Columbia 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 1 inclusion and 1 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 23 Jun 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility (time frame: Information not available). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2011.