DysphagiaFFWPNCT03672552
Using Plain Water With Oral Care to Increase Hydration for Long Term Care Residents With Disordered Swallowing
A study testing FFWP and Improved Oral Care in people with Dysphagia and Respiratory Tract Infections, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
The Frazier Free Water Protocol (FFWP) using plain, thin (unmodified) water is an accepted method to increase fluid intake and hydration in older adults with disordered swallowing and dementia.This study aims to take an interdisciplinary approach to see if the FFWP with improved oral care can be introduced in a long… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dysphagia, Respiratory Tract Infections
- What is being tested?
- FFWP and Improved Oral Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2019to 30 Nov 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Long Term Care Residents with moderate to severe swallowing difficulty and modified texture diet; or have a dry mouth and thirsty most of the time by report of patient participant, family or staff.
Who cannot join
- Participant Resident taking part in another study; participant finished another study in last 30 days prior to this study; Participant has dental pain or waiting to see a dentist for pain and discomfort; Participant has current chest infection including pneumonia or is prone to chest infections with more than one episode per year; Participant is unable to tolerate assessments and oral care.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Eastern Health-Pleasant View Towers
St. John's, Newfoundland and Labrador, A1A 0L7
About this study
Official title: Implementing the Frazier Free Water Protocol to Improve Hydration and Quality of Life in Long Term Care Residents
The Frazier Free Water Protocol (FFWP) using plain, thin (unmodified) water is an accepted method to increase fluid intake and hydration in older adults with disordered swallowing and dementia.This study aims to take an interdisciplinary approach to see if the FFWP with improved oral care can be introduced in a long term care (LTC) setting comparing an intervention group with a control group receiving standard oral care, to prevent respiratory infections.
Read the detailed description
The investigators will recruit a convenience sample of 36 participants from a single long-term care facility. Participants will be randomly assigned into control or intervention groups. Both groups will be assessed at study onset for swallowing and oral health and continue with agreed upon diet texture and fluid modifications. The intervention group (FFWP and improved oral hygiene) will receive a dental hygienist cleaning at onset of the study and have supervised tooth brushing before thin water between meals. The control group will continue with standard oral care and offered the full dental hygienist cleaning at the end of the study. If findings indicate no difference between groups on outcome measures (eg. respiratory illness, hydration, nutrition) then the intervention is considered efficacious in long-term care residents. If improvements in outcome measures are evident for the treatment relative to the control group, then this intervention may provide opportunity for improved healthcare and cost-savings.
- Conditions
- Dysphagia, Respiratory Tract Infections
- Being tested
- FFWP and Improved Oral Care
- Keywords
- Aspiration pneumonia, Dementia, Dysphagia, Oral hygiene, Long-term care, Frazier Free Water
- Medical subject headings
- Deglutition Disorders, Respiratory Tract Infections, Pneumonia, Aspiration, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFWP and Improved Oral CareOther
Also called Dental hygienist intervention and supervised tooth brushing
The FFWP with dental hygiene participants will have assessments for swallowing and oral health then proceed to have a dental hygienist cleaning. This intervention group will have supervised and assisted tooth brushing by nursing staff before taking plain (thin) unmodified water and between meals.
| Study group | Role | What they receive |
|---|---|---|
| FFWP and Improved Oral Care | Experimental | Receiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water). Receives: Other: FFWP and Improved Oral Care |
| Standard Care | No intervention | This group has assessments and standard oral care with no dental hygienist cleaning, no FFWP or supervised tooth brushing and continuing with agreed upon diet texture and fluid modification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Chest Infections
To determine whether the Frazier Free Water Protocol (FFWP) with improved oral care will decrease risk of respiratory illness events (eg. chest congestion, fever, etc.) for long term care residents by numbers of documented cases of upper and lower respiratory illnesses and hospital admissions over a 90-day duration.
Measured: Change from baseline (Day-0 to 90 days)
Secondary outcomes (3)
Incidence of positive experience with FFWP intervention.
Analysis of participant experience with FFWP intervention over the 90-day study period by scaled responses to feedback question: Did you feel this was a positive experience? Responses range from Strongly Agree, Agree, Disagree, Strongly Disagree and Neither Agree or Disagree.
Measured: Change from baseline (Day 0-90 days)
Change in Hydration
To assess change in hydration associated with FFWP intervention measured by lab values for electrolytes, BUN (Blood, Urea, Nitrogen) and Creatinine obtained over the 90-day study period.
Measured: Change from baseline (Day-0 to 90 days)
Change in Nutrition.
To assess change in nutrition associated with FFWP intervention measured by lab values for albumin, BUN (Blood, Urea, Nitrogen) and Creatinine obtained over the 90-day study period.
Measured: Change from baseline (Day 0 to 180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start19 Jun 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All study participants will have assessments for swallowing and oral hygiene. The intervention group will have a dental hygiene cleaning and supervised tooth brushing before taking plain, thin (unmodified) water and between meals. The control group will continue with standard oral care and the agreed upon diet texture and fluid modifications.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health, Newfoundland and Labrador Support for Patient-Oriented Research
- Responsible party
- Principal investigator, Roberta DiDonato, Memorial University of Newfoundland
- Investigators
- Roberta M DiDonato, PhD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672552
- Sponsor's protocol ID
- 2018.162
- Acronym
- FFWP
- Status last verified
- Feb 2020
- First submitted
- 8 Sep 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing guarded by privacy legislation and will require special application. Some documentation or research materials without participant data or identification may be shared.
Publications
Gillman A, Winkler R, Taylor NF. Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review. Dysphagia. 2017 Jun;32(3):345-361. doi: 10.1007/s00455-016-9761-3. Epub 2016 Nov 23.
PubMed 27878598Azarpazhooh A, Leake JL. Systematic review of the association between respiratory diseases and oral health. J Periodontol. 2006 Sep;77(9):1465-82. doi: 10.1902/jop.2006.060010.
PubMed 16945022Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clave P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing. 2010 Jan;39(1):39-45. doi: 10.1093/ageing/afp100. Epub 2009 Jun 26.
PubMed 19561160Forsell M, Kullberg E, Hoogstraate J, Johansson O, Sjogren P. An evidence-based oral hygiene education program for nursing staff. Nurse Educ Pract. 2011 Jul;11(4):256-9. doi: 10.1016/j.nepr.2010.11.017. Epub 2010 Dec 23.
PubMed 21185232Wirth R, Dziewas R, Beck AM, Clave P, Hamdy S, Heppner HJ, Langmore S, Leischker AH, Martino R, Pluschinski P, Rosler A, Shaker R, Warnecke T, Sieber CC, Volkert D. Oropharyngeal dysphagia in older persons - from pathophysiology to adequate intervention: a review and summary of an international expert meeting. Clin Interv Aging. 2016 Feb 23;11:189-208. doi: 10.2147/CIA.S97481. eCollection 2016.
PubMed 26966356Agarwal E, Marshall S, Miller M, Isenring E. Optimising nutrition in residential aged care: A narrative review. Maturitas. 2016 Oct;92:70-78. doi: 10.1016/j.maturitas.2016.06.013. Epub 2016 Jun 23.
PubMed 27621242
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the Frazier Free Water Protocol to Improve Hydration and Quality of Life in Long Term Care Residents
- ClinicalTrials.gov ID
- NCT03672552
- Acronym / sponsor ID
- FFWP / 2018.162
- Conditions
- Dysphagia, Respiratory Tract Infections
- Keywords
- Aspiration pneumonia, Dementia, Dysphagia, Oral hygiene, Long-term care, Frazier Free Water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Collaborators
- Eastern Health, Newfoundland and Labrador Support for Patient-Oriented Research
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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 Frazier Free Water Protocol (FFWP) using plain, thin (unmodified) water is an accepted method to increase fluid intake and hydration in older adults with disordered swallowing and dementia.This study aims to take an interdisciplinary approach to see if the FFWP with improved oral care can be introduced in a long term care (LTC) setting comparing an intervention group with a control group receiving standard oral care, to prevent respiratory infections.
Detailed description
The investigators will recruit a convenience sample of 36 participants from a single long-term care facility. Participants will be randomly assigned into control or intervention groups. Both groups will be assessed at study onset for swallowing and oral health and continue with agreed upon diet texture and fluid modifications. The intervention group (FFWP and improved oral hygiene) will receive a dental hygienist cleaning at onset of the study and have supervised tooth brushing before thin water between meals. The control group will continue with standard oral care and offered the full dental hygienist cleaning at the end of the study. If findings indicate no difference between groups on outcome measures (eg. respiratory illness, hydration, nutrition) then the intervention is considered efficacious in long-term care residents. If improvements in outcome measures are evident for the treatment relative to the control group, then this intervention may provide opportunity for improved healthcare and cost-savings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All study participants will have assessments for swallowing and oral hygiene. The intervention group will have a dental hygiene cleaning and supervised tooth brushing before taking plain, thin (unmodified) water and between meals. The control group will continue with standard oral care and the agreed upon diet texture and fluid modifications.
| Arm | Type | Receives |
|---|---|---|
| FFWP and Improved Oral Care | Experimental | Other: FFWP and Improved Oral CareReceiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water). |
| Standard Care | No intervention | –This group has assessments and standard oral care with no dental hygienist cleaning, no FFWP or supervised tooth brushing and continuing with agreed upon diet texture and fluid modification. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Long Term Care Residents with moderate to severe swallowing difficulty and modified texture diet; or have a dry mouth and thirsty most of the time by report of patient participant, family or staff.
Key exclusion criteria (1 listed)
- Participant Resident taking part in another study; participant finished another study in last 30 days prior to this study; Participant has dental pain or waiting to see a dentist for pain and discomfort; Participant has current chest infection including pneumonia or is prone to chest infections with more than one episode per year; Participant is unable to tolerate assessments and oral care.
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 |
|---|---|---|
| FFWP and Improved Oral CareAlso: Dental hygienist intervention and supervised tooth brushingThe FFWP with dental hygiene participants will have assessments for swallowing and oral health then proceed to have a dental hygienist cleaning. This intervention group will have supervised and assisted tooth brushing by nursing staff before taking plain (thin) unmodified water and between meals. | Other | FFWP and Improved Oral Care |
Primary outcome
Incidence of Chest Infections
Time frame: Change from baseline (Day-0 to 90 days)
To determine whether the Frazier Free Water Protocol (FFWP) with improved oral care will decrease risk of respiratory illness events (eg. chest congestion, fever, etc.) for long term care residents by numbers of documented cases of upper and lower respiratory illnesses and hospital admissions over a 90-day duration.
3 secondary outcomes
Incidence of positive experience with FFWP intervention.
Time frame: Change from baseline (Day 0-90 days)
Change in Hydration
Time frame: Change from baseline (Day-0 to 90 days)
Change in Nutrition.
Time frame: Change from baseline (Day 0 to 180 days)
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 3 Mar 2020.
- Results publication: PubMed 27878598Gillman A, Winkler R, Taylor NF. Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review. Dysphagia. 2017 Jun;32(3):345-361. doi: 10.1007/s00455-016-9761-3. Epub 2016 Nov 23.
- Results publication: PubMed 16945022Azarpazhooh A, Leake JL. Systematic review of the association between respiratory diseases and oral health. J Periodontol. 2006 Sep;77(9):1465-82. doi: 10.1902/jop.2006.060010.
- Results publication: PubMed 19561160Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clave P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing. 2010 Jan;39(1):39-45. doi: 10.1093/ageing/afp100. Epub 2009 Jun 26.
- Results publication: PubMed 21185232Forsell M, Kullberg E, Hoogstraate J, Johansson O, Sjogren P. An evidence-based oral hygiene education program for nursing staff. Nurse Educ Pract. 2011 Jul;11(4):256-9. doi: 10.1016/j.nepr.2010.11.017. Epub 2010 Dec 23.
- Results publication: PubMed 26966356Wirth R, Dziewas R, Beck AM, Clave P, Hamdy S, Heppner HJ, Langmore S, Leischker AH, Martino R, Pluschinski P, Rosler A, Shaker R, Warnecke T, Sieber CC, Volkert D. Oropharyngeal dysphagia in older persons - from pathophysiology to adequate intervention: a review and summary of an international expert meeting. Clin Interv Aging. 2016 Feb 23;11:189-208. doi: 10.2147/CIA.S97481. eCollection 2016.
- Results publication: PubMed 27621242Agarwal E, Marshall S, Miller M, Isenring E. Optimising nutrition in residential aged care: A narrative review. Maturitas. 2016 Oct;92:70-78. doi: 10.1016/j.maturitas.2016.06.013. Epub 2016 Jun 23.
- The Prevalence of Dysphagia in Long-Term Care Facility \[Thesis\]; Memorial University, St. John's , NLLink provided by the sponsor.
- Sources of Potentially Avoidable Emergency Department Visits. Ottawa: Canadian Institute of Health Information: Health System PerformanceLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data sharing guarded by privacy legislation and will require special application. Some documentation or research materials without participant data or identification may be shared.
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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.
Roberta M DiDonato, PhD principal investigator
Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFWP and Improved Oral Care in people with Dysphagia and Respiratory Tract Infections, run by Memorial University of Newfoundland 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 3 Mar 2020. 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?
Incidence of Chest Infections (time frame: Change from baseline (Day-0 to 90 days)). 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 NCT03672552, which also lists 6 linked publications.
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 3 Mar 2020.