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Trial registered on ANZCTR


Registration number
ACTRN12614000602628
Ethics application status
Approved
Date submitted
28/05/2014
Date registered
6/06/2014
Date last updated
6/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional Gastrointestinal Disorders: Design and evaluation of an algorithm-based approach to triage, diagnosis and management.
Scientific title
People with suspected functional gastrointestinal disorders: testing an algorithm based approach to global management as compared to waitlist control, is it acceptable, safe and effective?
Secondary ID [1] 284685 0
nil
Universal Trial Number (UTN)
U1111-1157-4336
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Gastrointestinal Disorders 292037 0
Condition category
Condition code
Oral and Gastrointestinal 292372 292372 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention employed is that of an algorithm-based approach to the triage, screening, diagnosis and evidence based management of functional gastrointestinal disorders.

The algorithm includes the screening of suspected FGID patients with routine blood and stool tests, the provision of a diagnostic letter to the patient and GP which incorporates current evidence-based management options including the low FODMAP diet and psychological therapy.

The intervention period is 6 weeks. In this 6 week period, patients will be screened via The Rome III Criteria (a validated survey to classify Functional Gastrointestinal Disorders), and undergo a panel of minimally invasive blood and stool tests. These results will be reviewed by a Gastroenterologist and a diagnosis made. Patients and their GPs will be informed of the diagnosis and recommended evidence based management options (via letter). Patients can freely choose to utililise as many or little of these recommendations as wanted. We will follow them up 6 weeks post intake to assess outcomes. Likewise, patients may continue or discontinue their chosen management options at any stage throughout this study. We are seeking to understand which options patients avail themselves on, the reasons behind these choices, and how successful the management options were for these patients.
Intervention code [1] 289473 0
Other interventions
Comparator / control treatment
The control group/treatment is waitlisted patients suspected of having a functional gastrointestinal disorder receiving usual care. Usual care is defined as any treatment commenced or investigations ordered by the patients GP whilst they are waiting for their appointment with the Gastroenterologist. Patients may also use any over the counter medications or alternative therapies during this time. We do not wish to alter any aspect of a patients normal wait-list experience, including other forms of treatment / management they use during this time. If this algorithm-based protocol shows good results, then it will be offered to the waitlist patients at the end of this study (i.e. 12 months).

In addition, the outcomes of the treatment group (where the treatment/intervention is participation in the algorithm based approach) will be compared with their baseline measures at intake.
Control group
Active

Outcomes
Primary outcome [1] 292232 0
Primary Outcome 1: Global patient satisfaction as assessed by survey data.
Timepoint [1] 292232 0
Timepoint 1: Baseline, and at 6 weeks, 6 months and 12 months after intake.
Primary outcome [2] 292233 0
Primary Outcome 2: Safety as assessed by the number of serious alternative diagnoses for the presenting symptoms obtained via medical records, GP and patient survey.
Timepoint [2] 292233 0
Timepoint: 12 months after intake.
Secondary outcome [1] 308484 0
Symptom severity: as assessed by the Global Symptom Rankng Score
Timepoint [1] 308484 0
Timepoint: Baseline, 6 weeks, 6 months, 12 months.
Secondary outcome [2] 308485 0
Visceral Hypersensitivity as assessed by the Visceral Hypersensitivity Index.
Timepoint [2] 308485 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months.
Secondary outcome [3] 308486 0
Catastrophising and generalisation as assessed by the Gastrointestinal Cognition Score
Timepoint [3] 308486 0
Timepoint: Baseline, 6 weeks, 6 months, 12 months.
Secondary outcome [4] 308487 0
Quality of Life as assessed by the World Health Organisation Quality of Life Questionnaire.
Timepoint [4] 308487 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [5] 308488 0
Mental Health as assessed by the Hospital Anxiety and Depression Scale.
Timepoint [5] 308488 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [6] 308489 0
Stress as assessed by the Depression Anxiety Stress Scale.
Timepoint [6] 308489 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [7] 308490 0
Coping skills as assessed by the Brief COPE questionnaire.
Timepoint [7] 308490 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [8] 308491 0
Health care seeking behaviour as assessed by custom designed patient survey data.
Timepoint [8] 308491 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [9] 308492 0
Work related impact of the disorder as assessed by the Workplace Absenteeism and Presenteeism Index.
Timepoint [9] 308492 0
Timepoint: Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [10] 308493 0
Patient acceptability as assessed by custom designed patient survey data.
Timepoint [10] 308493 0
Timepoint: 6 months and 12 months

Eligibility
Key inclusion criteria
Patients on the current waitlist in the Gastrointestinal Department of the Royal Adelaide Hospital with suspected functional gastrointestinal disorders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Mental or Cognitive Impairment
Interpreter required

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)
One third of the invited patients are being invited to the waitlist control group and two-thirds being invited to the intervention group.

Allocation is not concealed.


Intentional withholding of information from the wait list control group regarding the concurrent treatment arm of this study is planned in order to gain a satisfactory control group who are comparable to the active arm participants. We justify this, on the basis that:

Knowledge of the active arm is likely to reduce control patient satisfaction with their current situation and introduce a bias related simply to performing the study.

Control patients will not receive any less care than would occur if not in study from being on the wait list control group, nor does being on the wait list control put them at any risk of study-related harm

There is genuine equipoise in the proposal, as there is no generally accepted way to deal with this referral group in usual care settings

These patients have a non-progressive disorder and will be offered subsequent study participation after a short delay if results are positive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The first of every three patients identified as able to be invited will be invited to the control study, and the other two patients will be invited to the intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot study of a convenience sample to see whether such an algorithm based approach may improve patient outcomes. If the results are positive then a full RCT would be warranted. For this reason, sample size required has not been calculated.

The statistical analysis will be conducted using SPSS 21 and NVivo. Descriptive statistics will be used to describe the study population in the two arms at baseline. Groups (the experimental group versus the wait-list) will be compared on the primary outcome measure of global patient satisfaction at 12 months using the Analysis of Covariance (ANCOVA) with adjustment for baseline measures if the data are normally distributed, and using its non-parametric equivalent if the distribution proves skewed. Similar analyses will be conducted for the secondary outcome variables.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2512 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8152 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289307 0
Commercial sector/Industry
Name [1] 289307 0
Abbott
Country [1] 289307 0
Australia
Funding source category [2] 289308 0
Self funded/Unfunded
Name [2] 289308 0
Prof Jane Andrews Research Fund
Country [2] 289308 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide
North Terrace
Adelaide, SA, 5005
Australia
Country
Australia
Secondary sponsor category [1] 287978 0
None
Name [1] 287978 0
Address [1] 287978 0
Country [1] 287978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291072 0
Royal Adelaide Hospital HREC
Ethics committee address [1] 291072 0
Ethics committee country [1] 291072 0
Australia
Date submitted for ethics approval [1] 291072 0
Approval date [1] 291072 0
05/05/2014
Ethics approval number [1] 291072 0
HREC/14/RAH/132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48778 0
Ms Ecushla Linedale
Address 48778 0
Department of Medicine
University of Adelaide
Adelaide SA 5005
Country 48778 0
Australia
Phone 48778 0
+61 8 8222 4878
Fax 48778 0
Email 48778 0
ecushla.linedale@adelaide.edu.au
Contact person for public queries
Name 48779 0
Ecushla Linedale
Address 48779 0
Department of Medicine
University of Adelaide
Adelaide SA 5005
Country 48779 0
Australia
Phone 48779 0
+61 8 8222 4878
Fax 48779 0
Email 48779 0
ecushla.linedale@adelaide.edu.au
Contact person for scientific queries
Name 48780 0
Ecushla Linedale
Address 48780 0
Department of Medicine
University of Adelaide
Adelaide SA 5005
Country 48780 0
Australia
Phone 48780 0
+61 8 8222 4878
Fax 48780 0
Email 48780 0
ecushla.linedale@adelaide.edu.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePerformance of an algorithm-based approach to the diagnosis and management of functional gastrointestinal disorders: A pilot trial.2018https://dx.doi.org/10.1111/nmo.13243
N.B. These documents automatically identified may not have been verified by the study sponsor.