Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000898853
Ethics application status
Approved
Date submitted
15/08/2012
Date registered
23/08/2012
Date last updated
10/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing adherence to Obstructive Sleep Apnea treatment with a coaching intervention.
Scientific title
Increasing adherence to Obstructive Sleep Apnea treatment with a coaching intervention.
Secondary ID [1] 281034 0
Nil
Universal Trial Number (UTN)
U1111-1133-2492
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low self-efficacy in patients with Obstructive Sleep Apnea (OSA) 287021 0
Condition category
Condition code
Respiratory 287409 287409 0 0
Sleep apnoea
Mental Health 287410 287410 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either the current Treatment As Usual group (TAU) or a Coaching Group (C). Both TAU and C groups will undergo a psycho-education and mask fitting session (1.5 - 2 hours), a CPAP Titration study night, a 1 hour CPAP set-up session, and 4 CPAP data usage download sessions (each 1 hour in length). In addition, the C group will also receive four, one hour one-to-one coaching sessions – three face-to-face and one by phone.

The psycho-education is a group session of a standardised slide presentation containing information about normal sleep, daytime and night-time health consequences of untreated OSA , and the effectiveness of CPAP treatment. Side-effects encountered when using CPAP will be highlighted and discussed. All participants will have a trial of CPAP at a pressure of 4cm H20 in a supine position and will be encouraged to handle the equipment. Participants will also be encouraged to seek help and support for any mechanical difficulties throughout the study period.

During the CPAP titration night, subjects will undergo an in-laboratory manual titration of their CPAP pressure with polysomnography (PSG). CPAP-therapy pressure will be titrated to treat apnea, hypopnea, and flow limitation, with a therapy target of AHI<5 per hour of sleep. A prescription for an appropriate CPAP pressure and well sealing mask will be provided for participants.

The coaching sessions involve: Coaching Session 1 (immediately after the psycho-education and mask fitting session): to develop a collaborative relationship between coach and participant, help the participant develop personally meaningful coaching goals and explore how CPAP treatment can be incorporated into their lifestyle. Coaching Session 2 (immediately after the CPAP set-up session): This session will review and evaluate actions and progress to date. Participant generated goals will be set and action plans developed. The key focus will be on identifying areas of success thus far and coaching the participant to capitalise on these, although barriers to change will also be explored where relevant. Coaching Sessions 3 & 4: to help the participant prepare for longer-term use of the CPAP equipment, exploring ways to consolidate change and building self-efficacy, confidence and motivation levels. Session 3 will be between the 1st and 2nd download sessions and Session 4 will be immediately after the 3rd download session.
Intervention code [1] 285363 0
Behaviour
Comparator / control treatment
Treatment as Usual - psycho-education session and mask fitting
Control group
Active

Outcomes
Primary outcome [1] 287673 0
Adherence as measured by CPAP download (mean hours per night)
All participants will be provided with a CPAP device (provided by Air Liquide) with data-storage which allows for usage data to be directly downloaded from the machine or via a memory key. The data card/key records run time while the mask is on the patient's face and includes information about air leaks and apneas/hypopneas (complete or partial airway closures). The returned data will be downloaded by a CPAP therapist from Air Liquide and automatically analyzed using software provided by the device manufacturers.
Timepoint [1] 287673 0
After the following number of weeks of CPAP usage: 2 weeks, 5 weeks, 8 weeks, 12 weeks
Secondary outcome [1] 298615 0
Sleepiness and sleep related quality of life. Measured by: Epworth Sleepiness Scale (ESS)
Functional Outcomes Sleep Questionnaire (FOSQ)
Pittsburgh Sleep Quality Index (PSQI)]
Timepoint [1] 298615 0
Baseline, 3 months, 6 months
Secondary outcome [2] 298616 0
Mood and Wellbeing. Measured by:
Depression, Anxiety and Stress Scale 21 items (DASS-21)
Newark Cognitive Hardness Scale
Multidimensional Quality of Life Inventory
Timepoint [2] 298616 0
Baseline, 3 months, 6 months
Secondary outcome [3] 298617 0
Self-efficacy & related Variables. Measured by:
Social Cognitive Theory Questionnaire
SEMSA
Newark Cognitive Hardness Scale (resilience)
Solution-focussed thinking inventory
Timepoint [3] 298617 0
Baseline, 1 week, 1 month, 3 months, 6 months

Eligibility
Key inclusion criteria
Any patient (over 18 years) with untreated OSA and a low self-efficacy score (4 or lower)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous use of CPAP
Individuals not fluent in written and oral English

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)
Participants will have undergone a Sleep Study and diagnosed with Obstructive Sleep Apnea. At the follow-up visit with their Sleep physician they will be asked to complete a Self-efficacy questionnaire. Any patient with a self-efficacy score of 4 or less will be contacted for participation in this study. Once recruited participants will be randomised to a 1:1 ratio (treatment as usual or health coaching). The randomisation sequence will be prepared by a party independent of the trial, with randomly permuted block sizes. Allocation concealment will be ensured by use of sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be prepared by a party independent of the trial, with randomly permuted block sizes.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
27/08/2013
Date of last participant enrolment
Anticipated
Actual
7/06/2016
Date of last data collection
Anticipated
21/12/2016
Actual
Sample size
Target
60
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1754 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 7575 0
2037 - Glebe
Recruitment postcode(s) [2] 7576 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 285754 0
Commercial sector/Industry
Name [1] 285754 0
Air Liquide Healthcare
Country [1] 285754 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Air Liquide Healthcare
Address
Unit 5, 476 Gardeners Road, Alexandria, NSW, 2015
(Locked Bag 1008, Rosebery NSW, 1445)
Country
Australia
Secondary sponsor category [1] 284583 0
None
Name [1] 284583 0
Address [1] 284583 0
Country [1] 284583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287767 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 287767 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 287767 0
Australia
Date submitted for ethics approval [1] 287767 0
29/08/2012
Approval date [1] 287767 0
27/09/2012
Ethics approval number [1] 287767 0
HREC/12/RPAH/442

Summary
Brief summary
This project aims to (1) assess the effectiveness of a coaching intervention (C) in increasing adherence to CPAP compared with an enhanced education or treatment as usual (TAU) intervention; (2) to identify individuals with low self-efficacy scores who are at risk of stopping treatment and (3) to examine the role of mood, quality of life and well-being in the treatment response. The hypothesis is that the C intervention will increase uptake and adherence to CPAP and will improve low baseline self-efficacy scores as individuals feel they can perceive themselves using CPAP effectively. By using CPAP on a nightly basis for most of the night, mood and well-being, sleepiness and sleep related quality of life and self-efficacy will also be improved. A total of 60 individuals diagnosed with OSA will be recruited into the study on the basis of being naive to CPAP treatment and having low self-efficacy scores (<4). Participants will be randomised to either the current treatment as usual group (TAU) which consists of psycho-education and mask fitting (1.5 - 2 hours) before the CPAP titration night or a coaching group (C). The C group will undergo the psycho-education and mask fitting but will also undertake 4 individual coaching sessions at baseline (3 face-to-face session and 1 by telephone). All participants will be asked attend 4 CPAP data usage download sessions and to complete questionnaires at baseline, 1 week after starting CPAP, 1 month after starting CPAP, 12 weeks after starting CPAP and 3 months after study end. All participants will receive a CPAP machine and tubing free of charge for the duration of the study. Past CPAP research has found that self-efficacy predicts CPAP adherence, and as SF/CBC has been found to enhance self-efficacy and goal attainment and adherence, thus advancing knowledge and practice in CPAP and contributing to the broader emerging area of health coaching.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34499 0
A/Prof Delwyn Bartlett
Address 34499 0
Woolcock Institute of Medical Research 431 Glebe Point Road Glebe NSW 2037
Country 34499 0
Australia
Phone 34499 0
+61 2 9114 0460
Fax 34499 0
+ 61 2 9114 0014
Email 34499 0
[email protected]
Contact person for public queries
Name 17746 0
A/Prof Associate Professor Delwyn Bartlett
Address 17746 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe
NSW
2037
Country 17746 0
Australia
Phone 17746 0
+61 2 9114 0460
Fax 17746 0
+ 61 2 9114 0014
Email 17746 0
[email protected]
Contact person for scientific queries
Name 8674 0
A/Prof Associate Professor Delwyn Bartlett
Address 8674 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe
NSW
2037
Country 8674 0
Australia
Phone 8674 0
+61 2 9114 0460
Fax 8674 0
+ 61 2 9114 0014
Email 8674 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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