Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000122257
Ethics application status
Approved
Date submitted
8/01/2018
Date registered
29/01/2018
Date last updated
3/10/2024
Date data sharing statement initially provided
3/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the effects of a multidisciplinary Gastroenterology and Hepatology Integrated Care Clinic approach in patients with chronic gastrointestinal disorders: a randomised controlled trial.
Scientific title
The effects of a multidisciplinary Gastroenterology and Hepatology Integrated Care Clinic approach in patients with chronic gastrointestinal disorders: a randomised controlled trial.
Secondary ID [1] 293722 0
Unknown
Universal Trial Number (UTN)
n/a
Trial acronym
ICC
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Fatty Liver Disease 306069 0
Nonalcoholic Steatohepatitis 306071 0
stable Inflammatory Bowel Disease 306072 0
Irritable Bowel Syndrome 306073 0
Condition category
Condition code
Oral and Gastrointestinal 305206 305206 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 305208 305208 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Department of Gastroenterology and Hepatology at the Princess Alexandra
Hospital has recently established an Integrated Care Clinic as a strategy to help meet
the growing demands for Gastroenterology and Hepatology outpatient services, to
reduce waiting times and minimise risks to patients resulting from delayed health care
management. The Integrated Care Clinic provides a multi-disciplinary approach by
providing outpatient services cooperatively by GPs/specialists and nurses and well as
by allied health professionals including psychologists, dieticians and exercise
physiologists to manage patients with highly prevalent, but chronic conditions including
patients with functional gastrointestinal disorders such as irritable bowel syndrome (IBS)
as well as hepatology conditions such as non-alcoholic fatty liver disease (NAFLD).
This study is designed to compare the effects of standard care and the Integrated Care
Clinic on the health outcomes of patients in relation to psychological, dietary and activity
outcome parameters.

500 consecutive English-speaking patients diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH), as well as stable Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) will be will undergo routine
diagnostic work-up. Thereafter patients will be randomised to receive one of three
interventions:
Group One will receive the individualised integrated care model which includes
standardised assessment by a Gastroenterologist or Fellow, Psychologist, Dietician and
Exercise Physiologist and a Primary Care Physician (GP). Following the standardised
assessment, patients in Group one will receive a multidisciplinary integrated treatment
approach which will may include sessions by a Psychologist, Dietician, and Exercise
Physiologist as detailed under Integrated Care Model. The number of the treatment session will be determined by the individual clinicians to meet the patients needs. After
a maximum of 4 months patients with either return to standard care or discharge to their
GP.

Group Two will receive standard care which will include a standardised assessment
and routine management by a Gastroenterologist or Hepatologist. The treatment
approach will be defined during the case conference and the patients will receive in total
up to ten outpatient department (OPD) consultations with specialists, psychologists or allied health staff. After these 10 consultations, the patient is either discharged to the GP or continues to receive standard care in the OPD setting if this is deemed necessary by the gastroenterologists.

Group Three- Patients randomised to group three receive standard care in the OPD
setting. However, relevant outcome parameters will be collected 4, 12 and 26 weeks
after initiation of therapy.
Intervention code [1] 299977 0
Treatment: Other
Comparator / control treatment
Standard care in the outpatient department setting which includes initial consultation and treatment by a Gastroenterologist.
Control group
Active

Outcomes
Primary outcome [1] 304369 0
Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) to assess the intensity of gastrointestinal symptoms
Timepoint [1] 304369 0
SAGIS will be assessed at baseline, 4, 12 (primary endpoint) and 26 weeks after initiation of treatment.
Primary outcome [2] 304370 0
36-Item Short Form Survey (SF-36)- Quality of life
Timepoint [2] 304370 0
SF-36 will be assessed at baseline, 4, 12 (primary endpoint) and 26 weeks after initiation of treatment.
Primary outcome [3] 304371 0
Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression
Timepoint [3] 304371 0
HADS will be assessed at baseline, 4, 12 (primary endpoint) and 26 weeks after initiation of treatment.
Secondary outcome [1] 341756 0
International Physical Activity Questionnaire (IPAQ) to assess physical activity.
Timepoint [1] 341756 0
IPAQ will be assessed at baseline, 4, 12 and 26 weeks after initiation of treatment.
Secondary outcome [2] 341757 0
Work Productivity and Activity Impairment Questionnaire General Health (WPAI:GH) to assess work productivity
Timepoint [2] 341757 0
WPAI-GH will be assessed at baseline, 4, 12 and 26 weeks after initiation of treatment.

Eligibility
Key inclusion criteria
English-speaking patients who have been assessed by a specialist
medical consultant at Princess Alexandra Hospital. The specialist medical consultant
will ensure the patient is eligible for the study by confirming a diagnosis of Nonalcoholic
Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), stable Inflammatory
Bowel Disease (IBD), or Irritable Bowel Syndrome (IBS).
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
consecutive patients will be randomised to one of three treatment groups by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomised to one of three groups according to a stratified block randomisation scheme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will compare the primary outcomes of the intervention groups with regard to a) GI
symptoms intensity (SAGIS), b) quality of life domains (SF-36), c) anxiety and
depression (HADS), d) physical activity (IPAQ) and e) work productivity (WPAI:GH)
using the unpaired t-test. Confounding is unlikely due to randomization however the
potential will be assessed and analysis of covariance used instead should it be
identified. Should the assumption of Normality not be met, statistical inference will
employ the non-parametric bootstrap. Statistical significance will be defined as p<0.017
to allow for multiple related outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/01/2018
Actual
30/01/2018
Date of last participant enrolment
Anticipated
30/03/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
500
Accrual to date
480
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9693 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 18462 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297054 0
Hospital
Name [1] 297054 0
Princess Alexandra Hospital
Country [1] 297054 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 296058 0
None
Name [1] 296058 0
Address [1] 296058 0
Country [1] 296058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298238 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 298238 0
Ethics committee country [1] 298238 0
Australia
Date submitted for ethics approval [1] 298238 0
23/11/2017
Approval date [1] 298238 0
13/12/2017
Ethics approval number [1] 298238 0
HREC/17/QPAH/558

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

Contacts
Principal investigator
Name 76434 0
Prof Gerald Holtmann
Address 76434 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 76434 0
Australia
Phone 76434 0
61 07 3176 7792
Fax 76434 0
Email 76434 0
[email protected]
Contact person for public queries
Name 76435 0
Natasha Koloski
Address 76435 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 76435 0
Australia
Phone 76435 0
61 0407126897
Fax 76435 0
Email 76435 0
[email protected]
Contact person for scientific queries
Name 76436 0
Gerald Holtmann
Address 76436 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 76436 0
Australia
Phone 76436 0
61 07 3176 7792
Fax 76436 0
Email 76436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group results will be reported in any publications


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
No additional documents have been identified.