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Trial registered on ANZCTR


Registration number
ACTRN12612000825853
Ethics application status
Approved
Date submitted
31/07/2012
Date registered
6/08/2012
Date last updated
6/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the management of sleep disorders in the community
Scientific title
A community pharmacy-based intervention to pilot the use of actigraphy in monitoring patients with sleep disorders to improve the management of sleep disorders in the community settings
Secondary ID [1] 280923 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disorders 287010 0
Sleep-related symptoms 287011 0
Condition category
Condition code
Public Health 287343 287343 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Wrist actigraph:
- Actigraph is a 'wrist actiwatch', which has the ability to measure movement over extended periods of time using an acceloremeter to record and identify certain sleep parameters, and generate results of sleep quality, sleep quantity and sleep/wake timing. Actigraph provides an accurate estimation of sleep patterns in healthy adults and patients suspected of certain sleep disorders. A trained personnel is not a requisite for using the device, in fact actigraph has been used extensively in the studies of sleep and circadian rhythm in the non-laboratory and home-based settings. In this study, the participants will be wearing the actigraph for 24-hours continuously for 7 days. On day 8, the participants will revisit the pharmacy and the pharmacist will analyse the data downloaded from the actigraph using a Sleep Consultant software to generate an on -the-spot individualised report of sleep patterns (this is the first report). The participants will receive sleep advice and possible solutions based on the results from the pharmacist. After this session (follow-up 1), the participants will continue to wear the actigraph for another 7 days and return to the pharmacy for a second review on day 15 (follow-up 2). This time, the pharmacist will compare the results from the first report with the second report (which has been downloaded during this second visit) to determine any improvement in their sleep conditions.
2. Sleep diary:
- We will be using the NSF sleep diary. Sleep diary will be used in conjunction with the actigraph as both may complement each other by providing objective and subjective data. The participants will fill-in the sleep diary everyday for 7 days before revisiting the pharmacy (follow-up 1) on day 8. Data from the diary will be assessed and recorded by the pharmacist. Later the participants will continue to fill-in the sleep diary for another 7 days and return the diary to the pharmacist on day 15 (together with the actigraph) for final assessment. The participants will record their bedtime, wake time, time to fall asleep, number of nocturnal awakenings and total sleep time, plus information related to sleep hygiene, lifestyle and factors that may interrupt sleep in the sleep diary.
3. Face-to-face counselling:
- Counselling face-to-face (FTF) will be conducted at two time points, i.e. during first visit (day 8) and second visit (day 15) when the participants revisit the pharmacy for follow-ups and bring along the actigraph and sleep diary for assessment. This session will be conducted by a pharmacist at the participating community pharmacy for up to 1 hour duration (maximum). The pharmacists will deliver sleep advice and possible solutions about their sleep problems based on the above sleep parameters (actigraph and sleep diary) during this session. If there is no improvement in their conditions, pharmacist can recommend a general practitioner (GP) referral for further examination.
4. Baseline Surveys:
- Socio-demographic and lifestyle, health-related quality of life (HRQOL), Sleep scale scores (ESS, ISI, MAPI, IRLSSG) and community pharmacy survey.
5. End of study (Day 15 - during follow-up 2 at the community pharmacy)
- a set of 'end of study' survey forms: HRQOL, Sleep scale scores and close-out survey.
Intervention code [1] 285370 0
Early detection / Screening
Intervention code [2] 285377 0
Treatment: Devices
Intervention code [3] 285378 0
Prevention
Comparator / control treatment
Standard/usual care will be based on the usual practice at the participating community pharmacy in managing 'walk-in' individuals with sleep disorders and the related symptoms. Usually community pharmacies follow the Pharmaceutical Society of Australia's recommended practice for sleep problems, which may includes supplying 'Pharmacy medicine', 'Pharmacist only medicine', complementary medicine or over-the-counter medicines for sleep-related problems, if indicated. The same baseline surveys, i.e. socio-demographic and lifestyle, and questionnaire (HRQOL, sleep scale scores and community pharmacy survey) as in the intervention care group will be completed for comparison between groups. Control group will be followed-up at week 2 (day 15) by a study researcher via email or mail to complete a set of 'end of study' surveys.
Control group
Active

Outcomes
Primary outcome [1] 287610 0
Comparison of changes in health-related quality of life (HRQOL) scores between and within both groups using WHO-5 Well-being Index (1998)
Timepoint [1] 287610 0
At baseline and week 2
Primary outcome [2] 287611 0
Comparison of changes in sleep scale scores between and within both groups using Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Multivariate Apnea Prediction Index (MAPI) and International Restless Legs Syndrome Study Group (IRLSSG).
Timepoint [2] 287611 0
At baseline and week 2
Primary outcome [3] 287612 0
Comparison of changes in sleep parameters (Total sleep time per 24-hour period, TST; Percentage of sleep efficiency, SE%; Number of awakenings at night, NWAK; Sleep onset latency, SOL; Wake after sleep onset, WASO) between first (pre) and second (post) sleep reports generated from the actigraph.
Timepoint [3] 287612 0
At week 1 and week 2
Secondary outcome [1] 298527 0
Comparison between groups of baseline characteristics

- these include socio-demographic questions (age, gender, education level, ethnic background, employment status, occupation and shift work [normal/roster]).
-Lifestyle (smoking, alcohol consumption, caffeinated drinks intake).
These characteristics will be assessed using a questionnaire, developed based on a validated survey, i.e. POTASH (Saini et al. The Role of pharmacists in sleep health - a screening, awareness and monitoring program: final report. Sydney: The Pharmacy Guild of Australia, 2009)
Timepoint [1] 298527 0
At baseline
Secondary outcome [2] 298528 0
Patients' view about community pharmacy and a 'snapshot' on the use of community pharmacy to seek help for sleep-related disorders using a questionnaire.

The questionnaire (community pharmacy survey) was developed based on a few previous validated studies. This questionnaire has been validated in a pilot study.
Timepoint [2] 298528 0
At baseline
Secondary outcome [3] 298529 0
Comparison of changes in sleep-related lifestyle and personal behaviours related to sleep using a questionnaire.

-Questionnaire has been developed based on validated survey - POTASH (Saini et al, 2009).
Timepoint [3] 298529 0
At baseline and week 2

Eligibility
Key inclusion criteria
'Walk-in' customers who present at the community pharmacy to seek help for sleep-related disorders or have symptoms of sleep problems
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are not able to speak, read and write in English, unable to complete the screening, refuse to give consent, pregnant and those currently under treatment with continuous positive airway pressure (CPAP).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be selected from 'walk-in' customers who present at the participating community pharmacies seeking help for sleep disorders or have symptoms of sleep problems. In addition to the usual discussion and service for sleep problems, the pharmacists will offer the customers to join the study and explain the nature of the study. If they show interest, further discussion will be provided at a private area in the pharmacy. Customers who attend an intervention care pharmacy will be recruited in the intervention care group, whereas customers who attend a usual care pharmacy (control) will be recruited in the usual care group.
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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] 285719 0
University
Name [1] 285719 0
School of Pharmacy, University of Queensland
Address [1] 285719 0
Pharmacy Australia Centre of Excellence (PACE),
The University of Queensland,
20, Cornwall St.
Woolloongabba, Queensland 4102.
Country [1] 285719 0
Australia
Primary sponsor type
Individual
Name
Zaswiza Mohamad Noor
Address
School of Pharmacy,
Pharmacy Australia Centre of Excellence (PACE),
The University of Queensland,
20, Cornwall St.
Woolloongabba, Queensland 4102.
Country
Australia
Secondary sponsor category [1] 284548 0
Individual
Name [1] 284548 0
Dr Alesha Smith
Address [1] 284548 0
School of Pharmacy,
Pharmacy Australia Centre of Excellence (PACE),
The University of Queensland,
20, Cornwall St.
Woolloongabba, Queensland 4102.
Country [1] 284548 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287729 0
School of Pharmacy, University of Queensland Ethical Approval Committee
Ethics committee address [1] 287729 0
School of Pharmacy,
Pharmacy Australia Centre of Excellence (PACE),
The University of Queensland,
20, Cornwall St.
Woolloongabba, Queensland 4102.
Ethics committee country [1] 287729 0
Australia
Date submitted for ethics approval [1] 287729 0
Approval date [1] 287729 0
24/02/2012
Ethics approval number [1] 287729 0
Reference number 2012/04

Summary
Brief summary
This study is a pilot study to determine the potential effectiveness of a community pharmacy-based service for the management of sleep disorders in the community. This study aims to pilot the role of actigraphy as an objective measure in monitoring certain sleep disorders, and to pilot the extended role of community pharmacists in managing sleep disorders in the community. It is hypothesized that those who receive an actigraph will manage their sleep problems more effectively than those undergoing standard/usual care
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34494 0
Address 34494 0
Country 34494 0
Phone 34494 0
Fax 34494 0
Email 34494 0
Contact person for public queries
Name 17741 0
Dr Alesha Smith
Address 17741 0
School of Pharmacy,
Pharmacy Australia Centre of Excellence (PACE),
The University of Queensland,
20, Cornwall St.
Woolloongabba, Queensland 4102.
Country 17741 0
Australia
Phone 17741 0
+617 33461900
Fax 17741 0
Email 17741 0
asmith@pharmacy.uq.edu.au
Contact person for scientific queries
Name 8669 0
Zaswiza Mohamad Noor
Address 8669 0
School of Pharmacy,
Pharmacy Australia Centre of Excellence (PACE),
The University of Queensland,
20, Cornwall St.
Woolloongabba, Queensland 4102.
Country 8669 0
Australia
Phone 8669 0
+614 25498507
Fax 8669 0
Email 8669 0
zaswiza.bintimohamadnoor@uqconnect.edu.au

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