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Trial registered on ANZCTR


Registration number
ACTRN12619000523101
Ethics application status
Approved
Date submitted
22/03/2019
Date registered
2/04/2019
Date last updated
5/04/2019
Date data sharing statement initially provided
2/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial on the efficacy of audio-visual health educational materials on sleep health literacy and continuous positive airway pressure (CPAP) adherence in Sleep Clinic patients
Scientific title
Randomised controlled trial on the efficacy of audio-visual health educational materials on sleep health literacy and CPAP adherence in Sleep Clinic patients
Secondary ID [1] 297785 0
None
Universal Trial Number (UTN)
Trial acronym
AHEAD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 312135 0
Condition category
Condition code
Respiratory 310689 310689 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“Audio-visual clips” group:
Five educational health information videos related to obstructive sleep apnoea have been developed by the Department of Respiratory and Sleep Medicine.
Video 1 – About obstructive sleep apnoea: Introduction to the symptoms, initial consultation with GP and referral process to sleep specialist services. (approximately 4 minutes)
Video 2 – About the sleep study: Review of the preparation needed for attending a sleep study and what is involved. (approximately 1.5 minutes)
Video 3 – Accessing the Queensland Health Sleep Disorders Program: Requirements and processes for qualifying for a Queensland Government funded CPAP machine. (approximately 2 minutes)
Video 4 – What is CPAP and how does it work: Discussion of the indications, benefits and pitfalls of CPAP therapy. (approximately 2.5 minutes)
Video 5 – CPAP trouble shooting: How to care for your equipment and how to deal with common device troubles such as mask leak. (approximately 1.5 minutes)

For those participants in the intervention arm (“Audio-visual clips” group), following their usual sleep study set up at the Princess Alexandra Hospital sleep laboratory, a computer will be provided with Video 1 and Video 2 loaded, with assistance from the sleep scientists to play the video. Written and verbal education will also be provided at night by the sleep scientists according to standard laboratory policy and procedures. This includes a two-page written patient handout about the study and OSA. The following morning, the reviewing Sleep Physician will perform a preliminary sleep study data assessment and recommend interventions as standard of care. The participating patients will stay in the laboratory for an additional 20 minutes to watch video 3, 4 and 5. Adherence to the videos will be monitored by direct supervision by sleep scientists assisting to pay the videos.

The intervention is a once off event and will be generic to all the participants in the intervention arm.
Intervention code [1] 314022 0
Treatment: Other
Comparator / control treatment
Written and verbal education will also be provided at night by the sleep scientists according to standard laboratory policy and procedures. This includes a two-page written patient handout about the study and OSA. The handout on OSA has been prepared by the Sleep Disorders Clinic at Princess Alexandra Hospital, and is used in everyday practice in the sleep lab. The following morning, the reviewing Sleep Physician will perform a preliminary sleep study data assessment and recommend interventions as standard of care. The control group will not be shown any of the educational videos.
Control group
Active

Outcomes
Primary outcome [1] 319535 0
The primary outcome of this study is to determine CPAP adherence (hrs) in both standard of care and audio-visual arms. CPAP counter metres are present in all modern CPAP devices. This is a tamper-proof method whereby machine usage hours are detected by in-device computers and is usually downloaded at clinic follow up
Timepoint [1] 319535 0
2-months and 12-months (primary endpoint)
Secondary outcome [1] 368593 0
Non-scheduled sleep scientist time (phone calls and clinic consultation) measured in minutes. The Sleep Disorders staff at the Princess Alexandra Hospital already routinely collects this information via the Sleep Disorders database.
Timepoint [1] 368593 0
2-months and 12-months.
Secondary outcome [2] 368594 0
CPAP therapy uptake.
All patients initiated on CPAP therapy through the Sleep Disorders Clinic at Princess Alexandra Hospital are offered a review appointment at 2 months and 12 months. The proportion of patients who starts using CPAP therapy by 2 months and 12 months from their sleep study (either on a renal CPAP machine to qualify for the Queensland Health Sleep Disorders Programme or purchased machine) will be assessed. Patients who do not attend their clinic appointment will be contacted by telephone to inquire about CPAP uptake.
Timepoint [2] 368594 0
2-months and 12-months.

Eligibility
Key inclusion criteria
All treatment naïve patients attending Sleep Disorders Clinic for sleep studies with suspected or proven obstructive sleep apnoea who able to provide informed consent.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those unable to provide informed consent.
• Patients from non-English speaking background, as video clips will only be provided in English initially.
• Patients less than 18 years old.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Sealed envelopes containing cards method will be used. Equal number of cards for each arm will be placed in opaque envelopes.
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
The analysis will be carried out on an intention-to-treat principle. Estimated frequencies and proportions for the variables will be calculated in descriptive analysis. The Chi-Squared test will be used to compare the rates and t-test to compare means. The threshold for statistical significance will be established at 5%. Data quality will be assessed after data collection and potentially inform the analytical methods.

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)
QLD
Recruitment hospital [1] 13466 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 26079 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 302308 0
Hospital
Name [1] 302308 0
Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital
Address [1] 302308 0
199 Ipswich Rd, Woolloongabba QLD 4102
Country [1] 302308 0
Australia
Primary sponsor type
Hospital
Name
Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital
Address
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 302186 0
None
Name [1] 302186 0
Address [1] 302186 0
Country [1] 302186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302983 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 302983 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [1] 302983 0
Australia
Date submitted for ethics approval [1] 302983 0
11/02/2019
Approval date [1] 302983 0
21/03/2019
Ethics approval number [1] 302983 0
HREC/2019/QMS/50224

Summary
Brief summary
Sleep disorders, particularly obstructive sleep apnoea (OSA) are common conditions amongst the Australian adult population. Improving the patients’ understanding of OSA and the treatment with CPAP therapy is vital for properly treating the condition. Previous patients in our clinic have informed us that they would like health information regarding their sleep disorder to be made available in an online video format. We have developed five educational health information videos related to OSA. The main aim of this research is to determine how effective these videos are at improving patients’ understanding of OSA, uptake of CPAP therapy and usage of CPAP therapy.

A randomised controlled trial will be conducted. A total of 208 eligible patients will be randomised to either Group 1 “Standard of care” or Group 2 “audio-visual clips”. For patients in Group 1 (standard of care) education will be provided at night by the sleep scientists according to standard laboratory policy and procedures. For patients in Group 2 (audio-visual clips), five videos will be shown well as the standard education. The primary outcome of this study is to determine CPAP adherence (hrs) in both standard of care and audio-visual arms at 2-months and 12-months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92066 0
Dr Chinthaka Samaranayake
Address 92066 0
Department of Respiratory and Sleep Medicine
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 92066 0
Australia
Phone 92066 0
+61 7 3176 2698
Fax 92066 0
Email 92066 0
chinthaka.samaranayake@health.qld.gov.au
Contact person for public queries
Name 92067 0
Dr Chinthaka Samaranayake
Address 92067 0
Department of Respiratory and Sleep Medicine
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 92067 0
Australia
Phone 92067 0
+61 7 3176 2698
Fax 92067 0
Email 92067 0
chinthaka.samaranayake@health.qld.gov.au
Contact person for scientific queries
Name 92068 0
Dr Chinthaka Samaranayake
Address 92068 0
Department of Respiratory and Sleep Medicine
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 92068 0
Australia
Phone 92068 0
+61 7 3176 2698
Fax 92068 0
Email 92068 0
chinthaka.samaranayake@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality and site specific data custodian policy. The collected data will be stored on a secure Queensland Health computer located at the Department of Respiratory and Sleep Medicine at Princess Alexandra Hospital.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1705 0
Study protocol
Citation [1] 1705 0
Link [1] 1705 0
Email [1] 1705 0
Other [1] 1705 0
Summary results
No Results