Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001117505
Ethics application status
Approved
Date submitted
5/10/2015
Date registered
23/10/2015
Date last updated
23/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Flinders Chronic Condition Self-managment Program for Weight Loss in Obstructive Sleep Apnoea study
Scientific title
Flinders Chronic Condition Self-managment Program for Weight Loss in Obese Adults with Obstructive Sleep Apnoea study: Scale-up study to underpin application for large- scale trial
Secondary ID [1] 287600 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FOSA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 296405 0
Obesity 296406 0
Condition category
Condition code
Respiratory 296672 296672 0 0
Sleep apnoea
Diet and Nutrition 296673 296673 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise of a comprehensive approach to weight loss via the Flinders Program Flinders Chronic Condition Management Program which will be delivered to all participants. The Flinders Program (FP) was developed by the FHBHRU* and is used widely to enable patients to self-manage their chronic disease. The Flinders Chronic Condition Management Program will be delivered to all participants for 6 months.

Patients will also be offered a weight management Impromy program developed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) at no cost in addition to intensive support using behavioural techniques. The pharmacy-supervised Impromy program uses nutritious and highly accepted meal replacements as a means to weight loss.

Further details regarding the Flinders Program:
The Flinders Program provides a framework and tools that engage the patient and structure self- management assessment and tailored planning, motivational enhancement, disease management, prevention, coordination and outcome measurement. The first step is patient completion of the Partners in Health (PIH) tool, an as- sessment of self-management, knowledge, shared decision making, symptom management, adherence to medical management, impact of condition(s) and lifestyle behaviours. The clinician then uses the Cue and Response (C&R) tool to conduct an interview with the patient on the same items. This process leads to shared decisions on issues requiring intervention. Clinician and patient then identify the patient’s main (life) problem and set a medium term (6 month) goal using the Problem and Goals tool (P&G). The output is a care plan (the Flinders Care Plan tool) documenting issues that patient and clinician agree to act on over the following 6 months. At follow up contacts, the clinician monitors outcomes of the care plan using PIH and P&G scores, helps the patient to achieve goals using motivational and problem solving approaches and uses the structured framework of the Program to manage activities. The Flinders Program encompasses relevant evidence based patient education programs and the medical and psychiatric and community services that the patient agrees to access according to their priorities, therefore tailored to each individual. The program can be delivered face to face, by phone and/or electronically to suit patient needs.

Intensive support using behavioural techniques has been associated with success in weight loss programs including; providing instruction, prompting intention formation, specific goal setting, self-monitoring, review of behavioral goals and practice, feedback on performance, and relapse prevention and use of CBT and motivational interviewing. These behaviour change techniques are used within the Flinders Program therefore the weight-loss oriented component will be delivered directly by the Flinders Program clinician for patients choosing this option. Many of these techniques can be delivered telephonically or electronically for follow ups (eg motivational weight loss text messages, sharing self-monitoring measures) if this suits the patient.
If patients select alternative programs or resources to achieve their goals, this will be recorded and supported as part of the FP process. For other activities agreed between clinician and patient, local referral and community resources will be used (for example gyms, exercise groups, smoking cessation support services etc).

Participants will be followed-up over a 6 month period to assist them to achieve their goals. Over a 6 month period, participation in the trial will include:
1 x Flinders Program delivery session (maximum of 1 hour)
2 x Questionnaires completion and baseline blood pressure, height and weight measurements at 0 and 6 months (30 minutes each)
Optional: Meal replacement weight loss program (ImpromyTM program) with pharmacists’ support (and brief encounters) intermittently

Clinician training in use of the Program is provided by Flinders University on a cost-recovery basis via face-to-face sessions or nationally and internationally via on-line modules.

Integration of the Flinders Program with weight loss interventions:
In usual care, activities towards any weight loss goals within the FP, include identifying and joining available community and health service-provided weight loss programs. There are commonly significant barriers to timely access to evidence-based weight loss programs (availability, timing, location, cost and quality and appropriateness to patient needs).
Weight loss options that will be discussed with patients will include use of a meal replacement strategy, intensive support using behavioural techniques, and advice on how to access local community resources, such as gyms, exercise support groups, dieticians, exercise physiologists, etc.
All patients will be offered the option of using a meal replacement strategy, which for the purposes of this study will be the ImpromyTM program which focuses on improving health through weight loss and good nutrition. It comprises nutritious and highly accepted meal replacements along with high protein meal. The program has been developed by the CSIRO and is pharmacist driven. The program will be carried out via several conveniently-located pharmacies which supply ImpromyTM. It usually costs AUD49.95 per person for registration and support material; and AUD3.95 per meal replacement. It will be provided at no cost to participants for the purposes of this study. Further details of the Chronic Condition Self-management in Obstructive Sleep Apnoea program can be found at http://www.csiro.au/Outcomes/Health-and-Wellbeing/Prevention/Impromy-Health-and- Weight-Management-Program.aspx. Whilst we anticipate that the vast majority of patients will accept the Impromy meal replacement program, they will not be excluded from the study if they decide to focus on alternative strategies, such as intensive behavioural support, to achieve weight loss.

Patients will also receive usual sleep health care including an initial assessment and later review by asleep physician. Patients will likely, but not inevitably, commence CPAP therapy and for these patients, education about CPAP will be provided. Other therapies for OSA and the general health of the patient will be at the discretion of the treating physician as negotiated with the patient.
Intervention code [1] 292997 0
Treatment: Other
Comparator / control treatment
This is a phase 2 study which will use an approach commonly used in such early-phase studies, comparing outcomes of study participants with those of matched controls from a previously documented cohort in Chai-Coetzer CL et al's study 'Primary care vs specialist sleep center management of obstructive sleep apnea and daytime sleepiness and quality of life: a randomised trial", JAMA 2013;309:997-1004.24.( ACTRN12608000514303).

The comparison cohort of 74 patients received standard care for moderate-severe OSA by sleep physicians at the Adelaide Institute for Sleep Health between September 2008 and June 2010. Sleep specialists had completed their Fellow- ship of the Royal Australasian College of Physicians, having undertaken at least 3 years of respiratory medicine training in- cluding 1 year of full-time sleep medicine training. Treatment recommendations were left to the discretion of the treating sleep physician. Continuous positive airway pressure titration, if recommended, was conducted manually during laboratory PSG or by home autotitration.
Control group
Historical

Outcomes
Primary outcome [1] 296278 0
Body weight (Kg) change (compared to baseline prior to commencement of intervention); assessed by research personnel using weighing scales at the AISH
Timepoint [1] 296278 0
3 and 6 months after intervention commencement
Primary outcome [2] 296279 0
Body Mass Index (BMI) assessed via weight and height measurements calculated into a formula for BMI
Timepoint [2] 296279 0
at 3 and 6 months after intervention commencement
Primary outcome [3] 296390 0
Abdominal girth (cm) measured via measuring tape.
Timepoint [3] 296390 0
at 0 months and 6 months post commencement of study
Secondary outcome [1] 318038 0
Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS)
Timepoint [1] 318038 0
3 and 6 months after intervention commencement
Secondary outcome [2] 318039 0
Apnea Hypopnea Index (AHI)
Timepoint [2] 318039 0
3 and 6 months after intervention commencement
Secondary outcome [3] 318040 0
Continuous positive airway pressure (CPAP) treatment adherence assessed by downloaded CPAP adherence data from participant's CPAP machine (if undergoing CPAP treatment).
Timepoint [3] 318040 0
3 and 6 months after intervention commencement
Secondary outcome [4] 318041 0
Reaction time assessed by Psychomotor Vigilance Test (PVT)
Timepoint [4] 318041 0
at 3 and 6 months post intervention commencement
Secondary outcome [5] 318042 0
Blood Pressure measurements by sphygmomanometer.
Timepoint [5] 318042 0
at 3 and 6 months post intervention commencement

Eligibility
Key inclusion criteria
Moderate to severe obstructive sleep apnoea defined as an Apnea Hypopnea Index (AHI) of 20/hour or more,
Body Mass Index of 30 or more,
ESS (Epworth Sleepiness Scale) score of 8 or more,
Age 18-70, and
Ability to give voluntary written consent and to complete English-language self-report instruments.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe morbid obesity (body mass index [BMI]; neuromuscular disease; unstable psychiatric disease or cognitive impairment considered likely to interfere with adherence to instructions, completing the study or managing CPAP; hospitalization in the previous 3 months for myocardial infarction, unstable angina, cardiac failure, or cerebrovascular accident or New York Heart Association class III or IV symptoms; and lung disease with awake resting oxygen saturation of less than 92%). Patients who are pregnant, or are current participants in other research studies also will not be included.

Study design
Purpose of the study
Treatment
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
Other design features
The study will compare outcomes of study participants with those of matched controls from a previously documented cohort.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292164 0
University
Name [1] 292164 0
Flinders Medical Centre Foundation Seeding grant
Country [1] 292164 0
Australia
Primary sponsor type
Individual
Name
Dr Ching Li Chai-Coetzer
Address
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 290837 0
University
Name [1] 290837 0
Flinders Human Behaviour & Health Research Unit
Address [1] 290837 0
School of Medicine Flinders University Margaret Tobin Centre, Sturt Road, Bedford Park, South Australia,5042, GPO Box 2100
Country [1] 290837 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293637 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 293637 0
Flinders Medical Centre
The Flats G5 – Rooms 3 and 4
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 293637 0
Australia
Date submitted for ethics approval [1] 293637 0
13/02/2015
Approval date [1] 293637 0
12/06/2015
Ethics approval number [1] 293637 0
73.15 - HREC/15/SAC/64

Summary
Brief summary
The primary study hypothesis is that use of the Flinders chronic condition self-management program (FP) intervention will result in weight loss in patients with moderate to severe obstructive sleep apnoea (OSA) over a 6 month period compared to a cohort of historical patients matched for age, sex and baseline BMI with moderate-severe OSA.

INTERVENTION: The Flinders Chronic Condition Management Program will be delivered to all participants. The Flinders Program was developed by the Flinders Human Behaviour & Health Research Unit (FHBHRU) and is used widely to enable patients to self-manage their chronic disease. Patients will also be offered a weight management Impromy program developed by Commonwealth Scientific and Industrial Research Organisation (CSIRO) at no cost in addition to intensive support using behavioural techniques. The pharmacy-supervised Impromy program uses nutritious and highly accepted meal replacements as a means to weight loss.
DESIGN: A prospective cohort of 40 patients will be compared to a historical control cohort.
DURATION: Participants will be followed-up over a 6 month period to assist them to achieve their goals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60802 0
Dr Ching Li Chai-Coetzer
Address 60802 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 60802 0
Australia
Phone 60802 0
(+618) 8275 1187
Fax 60802 0
Email 60802 0
ChingLi.Chai-Coetzer@sa.gov.au
Contact person for public queries
Name 60803 0
Miss Catherine Hansen
Address 60803 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 60803 0
Australia
Phone 60803 0
(+618) 8275 1187
Fax 60803 0
Email 60803 0
catherine.hansen@health.sa.gov.au
Contact person for scientific queries
Name 60804 0
Dr Carissa Yap
Address 60804 0
Respiratory and Sleep Department
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 60804 0
Australia
Phone 60804 0
+61882045511
Fax 60804 0
Email 60804 0
carissa.yap@sa.gov.au

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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