Cerebrovascular DisordersPhase 2SOCLE IINCT01954212
Stroke Oral healthCare pLan Evaluation
A Phase 2 study testing Enhanced complex oral health care in people with Cerebrovascular Disorders and Stroke, run by Glasgow Caledonian University at 4 sites in United Kingdom.
Trial summary
Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged hospital stays and dependency at discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Disorders, Stroke, Pneumonia
- What is being tested?
- Enhanced complex oral health care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Oct 2013to Apr 2016
- Phase
- Phase 2
- 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
- All patients admitted to stroke care settings.
Who cannot join
- Consent declined.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Hairmyres Hospital
East Kilbride, Lanarkshire, G75 8RG
Stobhill Hospital
Glasgow, Scotland, G21 3UW
Royal Alexandra Hospital
Paisley, Scotland, PA2 9PN
Wishaw General Hospital
Wishaw, Lanarkshire, ML2 0DP
About this study
Official title: A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings: a Phase II Pilot Trial.
Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged hospital stays and dependency at discharge. Systematic review evidence indicates that enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar benefits might be observed in stroke care settings but current empirical evidence is weak - trial quality (randomisation, blinding, sample size, reporting), intervention description and thus feasibility of translation into clinical practice is very poor. Following an extensive pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus usual OHC. Investigators aim to establish a robust web-based randomisation process, refine the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage and sampling methodologies. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites.
Read the detailed description
SOCLE II is the pilot phase (Phase II) of a stepped-wedge cluster randomised controlled trial (RCT) of a complex oral health care (OHC) intervention versus usual OHC.
SOCLE II aims to evaluate the feasibility of a full scale pragmatic trial of the clinical and cost effectiveness of a complex OHC package of care versus usual care for people in stroke care settings. Ward level cluster randomisation will progress in a stepped wedge manner where after a period of baseline data collection each ward in a randomly allocated order will 'convert' from usual care to an enhanced oral health care intervention.
This pilot trial will assess the feasibility of delivering this enhanced OHC intervention across four sites and will inform the trial design of a full scale phase III trial including refining the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage, sampling methodologies, sample size calculations and pilot our health economic evaluation. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites. Our proposed pilot work will support an application for a planned Phase III definitive trial.
Principal Research Questions:
(i) Are the SOCLE intervention and data collection process viable across multiple sites? (ii) Can sample size calculations and estimates of recruitment and retention be refined? (iii) Can pneumonia event rates across several sites and distribution over time post stroke onset be determined? (iv) Can the association between dental and denture plaque and SAP be established? (v) Can the predetermined criteria for progression to Phase III definitive multi-centred stepped wedge cluster RCT with economic evaluation be met?
- Conditions
- Cerebrovascular Disorders, Stroke, Pneumonia, Oral Hygiene
- Being tested
- Enhanced complex oral health care
- Keywords
- Oral health
- Medical subject headings
- Cerebrovascular Disorders, Stroke, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced complex oral health careOther
Our proposed complex oral health care (OHC) intervention (SOCLE intervention) comprises 3 levels of intervention:
- Patient Level: An individualised OHC assessment on admission and individualised OHC plans for patients, which may involve staff-led OHC support, access to OHC equipment, products and specialist support services and OHC health promotion components.
- Staff Level: Specialist web-based OHC educational training, including information on the oral cavity and structures; oral health problems (e.g. decay, gum disease, dry mouth); instruction on OHC techniques, equipment and products; use of the SOCLE assessment and protocol tools.
- Service Level: Processes to facilitate access to specialist dental support services (e.g. dentist, hygienist, denture repair laboratory). Essential OHC equipment (toothbrushes, denture marking kits) and products (e.g. toothpaste, oral balance gel) on the ward will be available.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced complex oral health care intervention | Experimental | The complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions. Receives: Other: Enhanced complex oral health care |
| Usual oral health care | No intervention | Oral health care (OHC) will be provided in the standard manner, with no change to usual care. Provision of this standard OHC will be sampled monthly. Surveys suggest that standard oral health care (OHC) in stroke care settings comprise poorly supported OHC interventions delivered by staff that lacked access to specialist training, products, equipment, assessments, protocols and dental services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia
Based on the Mann Criteria for Chest infection and evaluated based on concurrent review of case notes at each weekly data collection point and a retrospective review of case notes on discharge.
Measured: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary outcomes (5)
Oral Health Impact Profile
Patient rated Oral Health Impact Profile (with activity and participation components, Locker et al 2002)
Measured: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Dental plaque
Measured: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Denture plaque
Measured: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Antibiotics prescribed
The prescription of antibiotics and type of antibiotic prescription will be documented from the drug kardex.
Measured: Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Death
Measured: Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit, University of Glasgow, NHS Lanarkshire, Glasgow Dental Hospital and School, University of Edinburgh
- Responsible party
- Principal investigator, Prof. Marian Brady, Glasgow Caledonian University
- Investigators
- Marian Brady, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954212
- Sponsor's protocol ID
- TSA 2012/09
- Acronym
- SOCLE II
- Status last verified
- Feb 2017
- First submitted
- 21 Aug 2013
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brady MC, Stott DJ, Weir CJ, Chalmers C, Sweeney P, Barr J, Pollock A, Bowers N, Gray H, Bain BJ, Collins M, Keerie C, Langhorne P. A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards. Int J Stroke. 2020 Apr;15(3):318-323. doi: 10.1177/1747493019871824. Epub 2019 Sep 30.
PubMed 31564241Brady MC, Stott D, Weir CJ, Chalmers C, Sweeney P, Donaldson C, Barr J, Barr M, Pollock A, McGowan S, Bowers N, Langhorne P. Clinical and cost effectiveness of enhanced oral healthcare in stroke care settings (SOCLE II): a pilot, stepped wedge, cluster randomized, controlled trial protocol. Int J Stroke. 2015 Aug;10(6):979-84. doi: 10.1111/ijs.12530. Epub 2015 Jun 16.
PubMed 26079661
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings: a Phase II Pilot Trial.
- ClinicalTrials.gov ID
- NCT01954212
- Acronym / sponsor ID
- SOCLE II / TSA 2012/09
- Conditions
- Cerebrovascular Disorders, Stroke, Pneumonia, Oral Hygiene
- Keywords
- Oral health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit, University of Glasgow, NHS Lanarkshire, Glasgow Dental Hospital and School, University of Edinburgh
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Oct 2013 (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.
Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged hospital stays and dependency at discharge. Systematic review evidence indicates that enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar benefits might be observed in stroke care settings but current empirical evidence is weak - trial quality (randomisation, blinding, sample size, reporting), intervention description and thus feasibility of translation into clinical practice is very poor. Following an extensive pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus usual OHC. Investigators aim to establish a robust web-based randomisation process, refine the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage and sampling methodologies. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites.
Detailed description
SOCLE II is the pilot phase (Phase II) of a stepped-wedge cluster randomised controlled trial (RCT) of a complex oral health care (OHC) intervention versus usual OHC.
SOCLE II aims to evaluate the feasibility of a full scale pragmatic trial of the clinical and cost effectiveness of a complex OHC package of care versus usual care for people in stroke care settings. Ward level cluster randomisation will progress in a stepped wedge manner where after a period of baseline data collection each ward in a randomly allocated order will 'convert' from usual care to an enhanced oral health care intervention.
This pilot trial will assess the feasibility of delivering this enhanced OHC intervention across four sites and will inform the trial design of a full scale phase III trial including refining the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage, sampling methodologies, sample size calculations and pilot our health economic evaluation. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites. Our proposed pilot work will support an application for a planned Phase III definitive trial.
Principal Research Questions:
(i) Are the SOCLE intervention and data collection process viable across multiple sites? (ii) Can sample size calculations and estimates of recruitment and retention be refined? (iii) Can pneumonia event rates across several sites and distribution over time post stroke onset be determined? (iv) Can the association between dental and denture plaque and SAP be established? (v) Can the predetermined criteria for progression to Phase III definitive multi-centred stepped wedge cluster RCT with economic evaluation be met?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced complex oral health care intervention | Experimental | Other: Enhanced complex oral health careThe complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions. |
| Usual oral health care | No intervention | –Oral health care (OHC) will be provided in the standard manner, with no change to usual care. Provision of this standard OHC will be sampled monthly. Surveys suggest that standard oral health care (OHC) in stroke care settings comprise poorly supported OHC interventions delivered by staff that lacked access to specialist training, products, equipment, assessments, protocols and dental services. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to stroke care settings.
Key exclusion criteria (1 listed)
- Consent declined.
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 |
|---|---|---|
| Enhanced complex oral health careOur proposed complex oral health care (OHC) intervention (SOCLE intervention) comprises 3 levels of intervention: 1. Patient Level: An individualised OHC assessment on admission and individualised OHC plans for patients, which may involve staff-led OHC support, access to OHC equipment, products and specialist support services and OHC health promotion components. 2. Staff Level: Specialist web-based OHC educational training, including information on the oral cavity and structures; oral health problems (e.g. decay, gum disease, dry mouth); instruction on OHC techniques, equipment and products; use of the SOCLE assessment and protocol tools. 3. Service Level: Processes to facilitate access to specialist dental support services (e.g. dentist, hygienist, denture repair laboratory). Essential OHC equipment (toothbrushes, denture marking kits) and products (e.g. toothpaste, oral balance gel) on the ward will be available. | Other | Enhanced complex oral health care intervention |
Primary outcome
Pneumonia
Time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Based on the Mann Criteria for Chest infection and evaluated based on concurrent review of case notes at each weekly data collection point and a retrospective review of case notes on discharge.
5 secondary outcomes
Oral Health Impact Profile
Time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Dental plaque
Time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Denture plaque
Time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Antibiotics prescribed
Time frame: Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Death
Time frame: Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.
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 28 Feb 2017.
- Derived from this study: PubMed 31564241Brady MC, Stott DJ, Weir CJ, Chalmers C, Sweeney P, Barr J, Pollock A, Bowers N, Gray H, Bain BJ, Collins M, Keerie C, Langhorne P. A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards. Int J Stroke. 2020 Apr;15(3):318-323. doi: 10.1177/1747493019871824. Epub 2019 Sep 30.
- Derived from this study: PubMed 26079661Brady MC, Stott D, Weir CJ, Chalmers C, Sweeney P, Donaldson C, Barr J, Barr M, Pollock A, McGowan S, Bowers N, Langhorne P. Clinical and cost effectiveness of enhanced oral healthcare in stroke care settings (SOCLE II): a pilot, stepped wedge, cluster randomized, controlled trial protocol. Int J Stroke. 2015 Aug;10(6):979-84. doi: 10.1111/ijs.12530. Epub 2015 Jun 16.
Related trials for Cerebrovascular Disorders
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Marian Brady principal investigator
Glasgow Caledonian University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enhanced complex oral health care in people with Cerebrovascular Disorders and Stroke, run by Glasgow Caledonian University at 4 sites in United Kingdom.
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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pneumonia (time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.). 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 NCT01954212, which also lists 2 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 28 Feb 2017.