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Trial registered on ANZCTR


Registration number
ACTRN12608000628347
Ethics application status
Approved
Date submitted
18/09/2008
Date registered
12/12/2008
Date last updated
12/12/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of pharmacists in sleep health –a screening, awareness and monitoring program
Scientific title
In people with risk of having or developing a sleep disorder, is a sleep screening done by a community pharmacy effective in identifying those at risk, and is a basic or more comprehensive screening more effective?
Universal Trial Number (UTN)
Trial acronym
Pharmacists and sleep health
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disorders 4126 0
Condition category
Condition code
Respiratory 3881 3881 0 0
Sleep apnoea
Mental Health 3882 3882 0 0
Other mental health disorders
Neurological 3883 3883 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure involves receiving a screening questionnaire to complete in a pharmacy, and , having this questionnaire examined by a trained pharmacist immediately after completion, if identified at high risk of having/developing sleep disorder, completing a sleep diary log for every night for 2 weeks and a sleep home study using a nasal flow monitoring device for 3 consecutive night on any 3 consecutive nights during which the sleep log is being recorded. This recording will be done only once within the duration of the project. If at the time of screening, there is no risk, simple counselling on healthy sleep practices will be provided.
The nasal airflow device is called the FlowWizard® will be delivered directly to the patients house via express post, if the pharmacist determines that the patient needs further screening.

It will take about five minutes to set up and is comfortable for
all night use. It will record for three nights. After use, the recorder is returned to the Woolcock Institute
of Medical Research via self-addressed postal pack for
immediate analysis.
A simple and clear report is then sent to via email/express letter to the pharmacist who can then attach this to their overall report to the General Practitioner (GP) nominated by patient to pharmacist who can then make a decision on what
other testing may be required for the patient or what type of treatment (if
any) should be started or if further referral to a sleep physician is needed.
Scientific information about the Flow Wizard appears in text below.
The FlowWizard is a single channel sleep apnea diagnostic device. A set of nasal pressure cannula are placed over the nostrils, and recordings can be made of airflow (breathing) are sampled for up to three 9-hour periods. The device is lightweight and can be despatched and returned in the post. Data stored in the device can be downloaded to a computer for automatic scoring to estimate the number of respiratory events (apneas and hypopneas) per hour. The device is TGA-approved.
Intervention code [1] 3427 0
Early detection / Screening
Comparator / control treatment
Screening using a questionnaire only- the questionnaires are assessed by a trained pharmacist immediately or as soon as possible after the patient completes them. The pharmacist determines the risk of the patient having or being at risk of a sleep disorder and provides a referral to a physician or if there is no risk, simple counselling on healthy sleep practices. The pharmacist counsels on one occassion - for the control group this will be on the day of the screening and for the intervention group the counselling may occur either on the day of the screening or 15 days later when patients have completed a sleep diary and have results from the FlowWizard screening. The patient will be followed in both groups after 3 months to pursue outcomes of referral or counselling, and if there are no outcomes yet(eg awaiting specialist appointments etc), the patients will be followed after another 2 months (total follow up time = 5 months).
Control group
Active

Outcomes
Primary outcome [1] 4784 0
Proportion of patients screened who are identified as being at risk of developing a sleep disorder, using a specfied scoring algorithm
Timepoint [1] 4784 0
January -March 2009, with a 3 month follow up ie March-June 2009
Secondary outcome [1] 8081 0
Proportion of patients screened who are diagnosed with a sleep disorder. This will be documented by conducting a project close out questionnaire with all patients to determine what changes they have made in their sleep practices, and what actions if any were taken by their physician when they presented with their referral document from the screening pharmacy.
Timepoint [1] 8081 0
January -March 2009, with a 3 month follow up ie March-June 2009

Eligibility
Key inclusion criteria
If recruitment targets have not been met through patient’s responding to the promotional phase, pharmacists will also be asked to invite all adult patients who have a dispensed medication history for any medications related to cardiovascular symptoms, diabetes, asthma, rhinitis or Chronic Obstructive Pulmonary Disease(COPD) (a checklist of medications will be provided to pharmacists). Patients inquiring about products to help fatigue and energy levels or weight reduction will also be invited to participate in the study.
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients already with a diagnosis of a sleep problem, or those < 18 years of age, or those with terminal/debilitating illness will not be included in the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pharmacies supplying CPAP equipment in NSW/ACT will be approached using a conveniene approach. Once ~20 are recruited, they will be randomised either to a basic screening(control) arm or a comprehensive arm( intervention). They will be offered training.


Following a training, all pharmacists will be provided with promotional materials. Posters will target people with symptoms and risk factors for sleep disorders, and invite them to talk to their pharmacist. Collaborative initiatives between pharmacy and other health care professionals will be set up at this stage. The Sleep Awareness Campaign will be run for three months. This will help in patuent self selecting to partcyipate. If this process does not manage to recruit sufficient numbers of patients, pharmacists will also be asked to invite all adult patients who have a dispensed medication history for any medications related to cardiovascular symptoms, diabetes, asthma, rhinitis or COPD (a checklist of medications will be provided to pharmacists). Patients inquiring about products to help fatigue and energy levels or weight reduction will also be invited to participate in the study.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4022 0
Commercial sector/Industry
Name [1] 4022 0
Pharmacy Guild of Australia
Address [1] 4022 0
Level 3, 15 National Circuit, Barton ACT 2600
Country [1] 4022 0
Australia
Funding source category [2] 4023 0
Commercial sector/Industry
Name [2] 4023 0
Pharmacy Guild of Australia
Address [2] 4023 0
Level 3, 15 National Circuit, Barton ACT 2600
Country [2] 4023 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Faculty of Pharmacy, Building A15, Science Road, Camperdown, NSW 2006 Australia.
Country
Australia
Secondary sponsor category [1] 3615 0
Other Collaborative groups
Name [1] 3615 0
Woolcock Institute of Medical Research
Address [1] 3615 0
Sleep and Circadian Group, WIMR
431, Glebe Point Road, Glebe NSW, 2037.
Country [1] 3615 0
Australia
Secondary sponsor category [2] 3616 0
Other Collaborative groups
Name [2] 3616 0
Woolcock Institute of Medical Research
Address [2] 3616 0
Sleep and Circadian Group, WIMR
431, Glebe Point Road, Glebe NSW, 2037.
Country [2] 3616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5947 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 5947 0
HREC, Room 3,Level 3, Old Teachers College, A22, Camperdown Campus, University of Sydney NSW 2006
Ethics committee country [1] 5947 0
Australia
Date submitted for ethics approval [1] 5947 0
Approval date [1] 5947 0
23/06/2008
Ethics approval number [1] 5947 0
Ethics committee name [2] 6103 0
Human Research Ethics Commitee, University of Sydney
Ethics committee address [2] 6103 0
HREC, Room 3,Level 3, Old Teachers College, A22, Camperdown Campus, University of Sydney NSW 2006
Ethics committee country [2] 6103 0
Australia
Date submitted for ethics approval [2] 6103 0
Approval date [2] 6103 0
23/06/2008
Ethics approval number [2] 6103 0
10765

Summary
Brief summary
Sleep disorders are a significant public health issue in Australia. The direct ‘health care’ costs of sleep disorders account for only 2% of their estimated economic impact ($10.3 billion) which suggests that there may be too little investment in the prevention and treatment of sleep disorders.
In a first of its kind, this project proposes to conduct a screening and awareness program to be run through community pharmacies by specially trained pharmacists. Further, the project aims to conduct a randomised controlled trial to evaluate the effectiveness of two sleep health models in the community pharmacy setting; a basic online screening tool for identification of sleep disorders versus a more comprehensive sleep screening and sleep health program for the diagnosis and reduction of patient risk factor profile for developing sleep disorders.

Through the participation of pharmacists, patients with sleep disorders will have improved access to information about the diagnosis, treatment and management of their conditions, especially in rural settings. The increased awareness and education about sleep health amongst pharmacists and the general public will allow for improved identification of sleep disorders and disease management, and lead to cost savings for patients, providers and the health care system. Given previous success of pharmacy based screening and intervention programs by the research team, the project has a high likelihood of success, and will deliver very valuable outcomes.

This will be the first project to test the effectiveness of community pharmacies as an alternative health care site for the improvement of sleep health outcomes in Australia, and one of the first globally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28950 0
Address 28950 0
Country 28950 0
Phone 28950 0
Fax 28950 0
Email 28950 0
Contact person for public queries
Name 12107 0
Mr Chris Robinson
Address 12107 0
A14 - Quadrangle
The University of Sydney
NSW 2006 Australia
Country 12107 0
Australia
Phone 12107 0
+61 2 93514795
Fax 12107 0
+61 2 93513256
Email 12107 0
chrisr@reschols.usyd.edu.au
Contact person for scientific queries
Name 3035 0
Dr Bandana Saini
Address 3035 0
Faculty of Pharmacy, Building A15, Science Rd, Faculty of Pharmacy, Camperdown Campus, University of Sydney, Camperdown NSW 2006.
Country 3035 0
Australia
Phone 3035 0
+61 2 93516789
Fax 3035 0
+61 2 93514391
Email 3035 0
bandana@pharm.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
No Results