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Trial registered on ANZCTR


Trial ID
ACTRN12617001077358p
Ethics application status
Submitted, not yet approved
Date submitted
23/03/2017
Date registered
25/07/2017
Date last updated
25/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacist screening of insomnia sufferers with a short screening tool, a pilot study
Scientific title
The Adapted Auckland Sleep Screening Tool of insomnia sufferers by pharmacists: A Pilot Study to determine workability of the tool, and referral of patients
Secondary ID [1] 291511 0
None known
Universal Trial Number (UTN)
U1111-1194-5583
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
insomnia 302599 0
Condition category
Condition code
Mental Health 302121 302121 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacists who have completed the Goodfellow training on Insomnia will use a screening tool (the adapted 2-page short Auckland Sleep Questionnaire developed by Arroll, Fernando and Falloon) and provide advice in the pharmacy including medical referral for people presenting with insomnia. This will take place face-to-face. The questionnaire has been adapted for pharmacy use by Arroll and Gauld following feedback from pharmacists and doctors. Medical referral is as per this sleep questionnaire which has clear referral points for possible underlying concerns affecting sleep (with input from doctors). The pharmacist would run through their consultation with a person with insomnia guided by this tool, noting answers to questions. Participants would then self-complete in a private room in the pharmacy the full validated 7-page Auckland Sleep Questionnaire (from which the short Auckland Sleep Questionnaire was derived) for use by researchers only. The pharmacist would then diagnose primary insomnia or refer to a doctor according to the tool and/or provide advice (e.g. sleep hygiene) as the pharmacist deems appropriate (noting their recent Goodfellow training on Insomnia and undergraduate training in this area and according to the answers the person has given, e.g. drinking caffeine or alcohol). Pharmacists will use their usual referral process, which could involve advising the participant to see their doctor or send a notification to the doctor - this will be at the pharmacist's discretion.
The screening tool looks for underlying causes of insomnia, e.g. indications of depression, obstructive sleep apnoea, etc.
The pharmacist will ring 2 weeks later to ask what action was taken and what effect it had.
Intervention code [1] 297587 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301554 0
Is the 2-page adapted short Auckland Sleep Questionnaire screening tool feasible for use in pharmacy? Pharmacists will document duration of the consultation, utility of the tool and possible improvements
Timepoint [1] 301554 0
End of study (after at least 120 participants have completed screening (max 144 to be screened))
Primary outcome [2] 301556 0
How many people presenting to pharmacy have primary insomnia? The 2-page screening tool adapted from one developed for general practice (short Auckland Sleep Questionnaire - Arroll, Fernando and Falloon), and the 7-page validated gold standard questionnaire (Auckland Sleep Questionnaire - Arroll, Fernando and Falloon) will identify possible underlying causes, or if none exist, primary insomnia.
Timepoint [2] 301556 0
End of study after at least 120 participants (up to 144 participants) have been screened
Primary outcome [3] 301806 0
How many people need referral for possible underlying conditions? Assessed using the pharmacist's clinical judgement following the 2-page screening tool, and from indications of underlying disorders in the 7-page validated gold standard questionnaire (The Auckland Sleep Questionnaire: Arroll, Fernando & Falloon).
Timepoint [3] 301806 0
End of study (after at least 120 participants have completed screening (max 144 to be screened))
Secondary outcome [1] 333018 0
How well does the 2-page screening tool align with the gold standard Auckland Sleep Questionnaire 7-page screening tool in identifying primary insomnia and possible underlying causes? Findings from each tool will be compared for each participant, with reporting on possible underlying causes identified (e.g. possible depression or anxiety) and findings of primary insomnia, and this will be reported (noting it is pilot phase).
Timepoint [1] 333018 0
End of study when at least 120 participants have completed the screening tool (max 144 participants based on 12 per pharmacist).
Secondary outcome [2] 333234 0
What proportion of participants had taken the advice of the pharmacist at 2 weeks?The pharmacist will contact the participant 2 weeks after the consultation using a brief questionnaire designed specifically for this study.
Timepoint [2] 333234 0
The data is collected 2 weeks after the participant's consultation with the pharmacist, but all data will be analysed after a minimum of 120 participants have been screened (max 144).
Secondary outcome [3] 333910 0
What was the outcome of that advice? (e.g. medical diagnosis, sleep improvement, no change)
Timepoint [3] 333910 0
The data is collected 2 weeks after the participant's consultation with the pharmacist, but all data will be analysed after approximately 120 participants have been screened (max 144 can be included).

Eligibility
Key inclusion criteria
Adults 18 years and over purchasing a sleep remedy or with trouble sleeping who are in the pharmacy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to read or understand English
Taking prescription medicines for sleep 2 or more nights per week

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
Single group
Other design features
Qualitative work as well
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Feasibility study

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 outside Australia
Country [1] 8758 0
New Zealand
State/province [1] 8758 0

Funding & Sponsors
Funding source category [1] 296001 0
Charities/Societies/Foundations
Name [1] 296001 0
NZ Pharmacy Education and Research Foundation
Address [1] 296001 0
PO Box 11640, Manners St, Wellington 6142
Country [1] 296001 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Natalie Gauld Ltd
Address
PO Box 9349, Newmarket, Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 294888 0
None
Name [1] 294888 0
Address [1] 294888 0
Country [1] 294888 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297261 0
Health and Disability Ethics Committees
Ethics committee address [1] 297261 0
Ethics committee country [1] 297261 0
New Zealand
Date submitted for ethics approval [1] 297261 0
06/04/2017
Approval date [1] 297261 0
Ethics approval number [1] 297261 0

Summary
Brief summary
Insomnia is a common reason for purchasing complementary remedies in pharmacy or seeking advice in pharmacy. However, it may indicate an underlying problem. There is no comprehensive screening tool that has been developed for pharmacy use to ascertain where insomnia may be secondary to another cause (e.g. depression, sleep apnoea). A short screening tool that has been validated in general practice in NZ will be adapted and used in pharmacy. We will look for workability of the tool for the pharmacist (how long it takes, how useful it is), findings of the questionnaire (compared to the gold-standard questionnaire), frequency of medical referral. We will compare the outcomes of the questionaire with the gold standard 7-page questionnaire.
Consumers presenting in the pharmacy for a sleep remedy or for advice on insomnia for themselves will do the short 2-page questionnaire with the pharmacist. The pharmacist will provide advice e.g. on sleep hygiene or medical referral based on this questionnaire and their expertise. The participant will self -complete the 7-page questionnaire for return to the researchers.
The pharmacist will follow up the participant after 2 weeks to ascertain what (if any) action was taken by the participant, the outcomes of this action (e.g. new diagnosis by the doctor), and whether sleep was thought to have improved, worsened or stayed the same.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73502 0
Dr Natalie Gauld
Address 73502 0
Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
Country 73502 0
New Zealand
Phone 73502 0
+649 630 5683
Fax 73502 0
Email 73502 0
n.gauld@auckland.ac.nz
Contact person for public queries
Name 73503 0
Dr Natalie Gauld
Address 73503 0
Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
Country 73503 0
New Zealand
Phone 73503 0
+6496305683
Fax 73503 0
Email 73503 0
n.gauld@auckland.ac.nz
Contact person for scientific queries
Name 73504 0
Dr Natalie Gauld
Address 73504 0
Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
Country 73504 0
New Zealand
Phone 73504 0
+6496305683
Fax 73504 0
Email 73504 0
n.gauld@auckland.ac.nz