Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001246370
Ethics application status
Approved
Date submitted
19/08/2017
Date registered
25/08/2017
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of an Internet-based Decision Aid (myAID) for Ulcerative Colitis Patients to Improve Quality of Life, Empowerment, Decision Making and Disease Control
Scientific title
A Cluster Randomised Controlled Trial of a Decision Aid (myAID) for Ulcerative Colitis Patients to Enhance Patients Quality of Life, Empowerment, Quality of Decision Making and Disease Control
Secondary ID [1] 292444 0
Nil known
Universal Trial Number (UTN)
Trial acronym
myAID (my Actively Informed Decision) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 304058 0
Condition category
Condition code
Inflammatory and Immune System 303383 303383 0 0
Autoimmune diseases
Oral and Gastrointestinal 303799 303799 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall aim of the project is to improve, through the implementation of a decision aid (myAID), quality of life, empowerment, quality of decision making, and disease control of patients receiving treatment for ulcerative colitis (UC). myAID is an internet-based multimedia decision aid (Emmi Solutions, Chicago) designed to support shared decision making for treatment choices in UC management. Its content was determined following a survey of 460 UC patients from USA and Australia which confirmed that most patients with UC want better understanding about UC and its treatments, and wish to participate in shared decision making with their gastroenterologist when making treatment decisions.

Content: Organised into small chapters that can be viewed repeatedly as necessary, myAID aims to enhance the viewer's understanding of UC including its risks and potential complications, goals of treatment as well as benefits and risks of a range of surgical and medical treatment options available.

Interactivity: myAID can be accessed using any computer by a unique link assigned to the viewer during the study. Study participants will be asked to view myAID in their own time and space. myAID has several interactive components that prompt patients to answer questions about their current symptoms and concerns, allows them to return and skip to a specific chapter of their interest after viewing the entire tool at least once, and to take virtual notes and print these as required to discuss with their doctor. A summary of all the information provided in myAID can also be printed once all the contents have been viewed.

The intervention will be administered in a two arm, prospective cluster randomised controlled trial involving 22 sites across New South Wales (NSW), South Australia (SA), Victoria (Vic), Queensland (QLD) and Western Australia (WA). Half ie 11 of the sites or clusters will be allocated to the intervention arm where myAID will be made accessible to patients routinely throughout the 12-month study period in addition to usual care.

Consenting patients will be asked to complete a baseline online questionnaire and test for faecal calprotectin before they view myAID and return to their consultant for further discussion about their management. All participants in the intervention arm of the study will be required to view myAID at least once, as they will not be able to progress through the study without viewing it (which will constitute a minimum requirement of the baseline assessment for them). From thereon, they will be encouraged to view myAID as often as necessary to help with their decision making during the entire study period. An online questionnaire will be completed after the initial viewing of myAID to assess the patient’s perception of the usefulness and acceptability of myAID, and whether the patient used any other information material than myAID. Additional online questionnaires and FC samples will be collected at 2 months, 6 months, and 12 months, all of which can be done from the patient’s home. The online questionnaires will collect patient’s demographic and basic clinical information eg hospital admissions, and also ask the patient to complete the following measures: Assessment of Quality of Life-8D, Health Literacy Questionnaire, Health Education Impact Questionnaire, Decisional Conflict Scale, Trust in Physician Scale, Hospital Anxiety and Depression Scale – Anxiety, Medication Adherence Visual Analogue Scale, Simple Clinical Colitis Activity Index, and Work Productivity and Activity Index.
Intervention code [1] 298654 0
Behaviour
Comparator / control treatment
Patients recruited from sites or clusters allocated to the control arm in the study will receive usual care without the use of the decision aid during the 12-month study period. Patients will be reviewed by their respective gastroenterologist (or team) within 2-4 weeks of study inclusion to help with the decision making process, and be asked to complete an online questionnaire to assess whether they used any information material to help in this process. All patients will complete the same online questionnaires and submit FC samples as those in the intervention arm at 2 months, 6 months, and 12 months to allow comparison of designated primary and secondary outcomes during the study.
Control group
Active

Outcomes
Primary outcome [1] 302831 0
Health-related quality of life, as measured by Assessment of Quality of Life-8D
Timepoint [1] 302831 0
6 months
Secondary outcome [1] 337180 0
Empowerment, as measured by Health Education Impact Questionnaire 3.0
Timepoint [1] 337180 0
12 months
Secondary outcome [2] 337181 0
Health literacy, as measured by Health Literacy Questionnaire
Timepoint [2] 337181 0
12 months
Secondary outcome [3] 337182 0
Quality of decision making, as measured by Decisional Conflict Scale
Timepoint [3] 337182 0
12 months
Secondary outcome [4] 338061 0
Quality of decision making, as measured by Trust in Physician Scale
Timepoint [4] 338061 0
12 months
Secondary outcome [5] 338062 0
Anxiety, as measured by Hospital Anxiety Depression Scale - Anxiety
Timepoint [5] 338062 0
12 months
Secondary outcome [6] 338063 0
Productivity, as measured by Work Productivity and Activity Index
Timepoint [6] 338063 0
12 months
Secondary outcome [7] 338064 0
Medication adherence, as measured by a visual analogue rating scale
Timepoint [7] 338064 0
12 months
Secondary outcome [8] 338065 0
Disease activity and control, as measured by the Simple Clinical Colitis Activity Index
Timepoint [8] 338065 0
12 months
Secondary outcome [9] 338066 0
Disease activity and control, as measured by faecal calprotectin
Timepoint [9] 338066 0
12 months
Secondary outcome [10] 338067 0
Disease activity and control, as measured by proportion of patients taking steroids (captured through self-report via online questionnnaire)
Timepoint [10] 338067 0
12 months
Secondary outcome [11] 338068 0
Disease activity and control, as measured by proportion of patients requiring surgery (captured through self-report via online questionnnaire)
Timepoint [11] 338068 0
12 months
Secondary outcome [12] 338069 0
Disease activity and control, as measured by proportion of patients requiring unplanned hospital admissions (captured through self-report via online questionnnaire)
Timepoint [12] 338069 0
12 months
Secondary outcome [13] 338070 0
Acceptability of the decision aid, as measured by questions specifically developed for the study
Timepoint [13] 338070 0
Within 2-4 weeks of initial viewing of myAID (intervention arm only)

Eligibility
Key inclusion criteria
Patients will be eligible to participate in the study if they:
a) have a diagnosis of ulcerative colitis (UC);
b) are 18+ years;
c) have failed or are failing oral +/- rectal 5-aminosalicylate (5-ASA) therapy or any therapy beyond 5-ASAs (failure includes non-adherence);
d) are making a new decision about therapy;
e) can communicate in English; and
f) have access to internet and email
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) patients with no prior exposure to 5-ASAs;
b) inpatients with severe colitis or acute severe UC;
c) post colectomy patients at baseline;
d) patients that do not meet above inclusion criteria.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a computer software
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
This study is powered to detect a difference of 0.5 SD between the Intervention and Usual Care groups in the primary outcome of QoL using the AQoL-8D measure. The sample size has been adjusted for the design effect due to the clustered design and can accommodate an intra-class correlation coefficient (ICC) as high as 0.05 to achieve 80% power. Adjusting for this ICC, the estimated required sample size for the full study is 238 patients in total (119 per group). Assuming 70% of eligible patients consent to study participation and a loss to follow up rate of 20% at the 12-month end-point, we aim to approach 426 patients in total (213 per group). Across all sites, recruitment and follow up can be achieved in approximately 30 months.
The primary analysis will be conducted for the primary outcome using multilevel models to account for the correlation of outcomes within a cluster (site). For the primary outcome, the dependent variable will be the QoL measure and the exposure variable will be the intervention status (usual care versus intervention). The unit of analysis will be at the patient level to accommodate the weighting required by unequal cluster (site) sizes. Other independent variables will be added to the models if they are independently associated with the QoL measure and/or their inclusion in the model changes the linear coefficient of the intervention effect by more than 20% in absolute value. Multilevel models will also be used to evaluate secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/10/2016
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
426
Accrual to date
280
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 8590 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 8591 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 8592 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 8593 0
St George Hospital - Kogarah
Recruitment hospital [5] 8594 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 8595 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [7] 8596 0
Wollongong Hospital - Wollongong
Recruitment hospital [8] 8597 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [9] 8598 0
The Alfred - Prahran
Recruitment hospital [10] 8599 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [11] 8600 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [12] 8601 0
Box Hill Hospital - Box Hill
Recruitment hospital [13] 8602 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [14] 8603 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 8604 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [16] 8605 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [17] 8606 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [18] 8607 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [19] 11537 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [20] 11538 0
Wagga Endoscopy Centre - Wagga Wagga
Recruitment hospital [21] 11539 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [22] 11540 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 16697 0
2170 - Liverpool
Recruitment postcode(s) [2] 16698 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 16699 0
2139 - Concord
Recruitment postcode(s) [4] 16700 0
2217 - Kogarah
Recruitment postcode(s) [5] 16701 0
2148 - Blacktown
Recruitment postcode(s) [6] 16702 0
2050 - Camperdown
Recruitment postcode(s) [7] 16703 0
2500 - Wollongong
Recruitment postcode(s) [8] 16704 0
3065 - Fitzroy
Recruitment postcode(s) [9] 16705 0
3004 - Prahran
Recruitment postcode(s) [10] 16706 0
3168 - Clayton
Recruitment postcode(s) [11] 16707 0
4101 - South Brisbane
Recruitment postcode(s) [12] 16708 0
3128 - Box Hill
Recruitment postcode(s) [13] 16709 0
6008 - Subiaco
Recruitment postcode(s) [14] 16710 0
5000 - Adelaide
Recruitment postcode(s) [15] 16711 0
5011 - Woodville
Recruitment postcode(s) [16] 16712 0
5042 - Bedford Park
Recruitment postcode(s) [17] 16713 0
6150 - Murdoch
Recruitment postcode(s) [18] 16714 0
4029 - Herston
Recruitment postcode(s) [19] 23565 0
2065 - St Leonards
Recruitment postcode(s) [20] 23566 0
2650 - Wagga Wagga
Recruitment postcode(s) [21] 23567 0
3050 - Parkville
Recruitment postcode(s) [22] 23568 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 297010 0
Government body
Name [1] 297010 0
South Western Sydney Local Health District Mid-Career Grant
Country [1] 297010 0
Australia
Funding source category [2] 297140 0
Charities/Societies/Foundations
Name [2] 297140 0
Gastroenterological Society of Australia IBD Clinical Research Grant 2016
Country [2] 297140 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Susan Connor
Address
Department of Gastroenterology & Hepatology
Clinic 123 Level 1 Liverpool Hospital Liverpool NSW 2170

Psycho-Oncology Research Group, Ingham Institute
Liverpool Hospital, Locked Bag 7103. Liverpool BC NSW 1871 Australia
Country
Australia
Secondary sponsor category [1] 296011 0
Individual
Name [1] 296011 0
Professor Afaf Girgis
Address [1] 296011 0
Psycho-Oncology Research Group, Ingham Institute
Liverpool Hospital, Locked Bag 7103, LIVERPOOL BC NSW 1871 Australia
Country [1] 296011 0
Australia
Other collaborator category [1] 279675 0
Other
Name [1] 279675 0
Ingham Institute for Applied Medical Research
Address [1] 279675 0
1 Campbell Street
Liverpool NSW 2170
Australia
Country [1] 279675 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298200 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 298200 0
Ethics committee country [1] 298200 0
Australia
Date submitted for ethics approval [1] 298200 0
27/07/2015
Approval date [1] 298200 0
15/10/2015
Ethics approval number [1] 298200 0
HREC/15/LPOOL/358

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1982 1982 0 0
/AnzctrAttachments/373313-NEAF Approval 18.10.15.pdf (Ethics approval)
Attachments [2] 1987 1987 0 0
/AnzctrAttachments/373313-MASTER Patient Information Sheet V6_clean.pdf (Participant information/consent)
Attachments [3] 1988 1988 0 0
/AnzctrAttachments/373313-Local Liverpool Patient Information Sheet V6_clean.pdf (Participant information/consent)
Attachments [4] 2929 2929 0 0
/AnzctrAttachments/373313-myAID Study Protocol V4 2 Nov 2017_Clean.docx (Protocol)
Attachments [5] 2930 2930 0 0
/AnzctrAttachments/373313-myAID Study Patient Information Sheet V7_2 Nov 2017_Clean.docx (Participant information/consent)
Attachments [6] 2931 2931 0 0
/AnzctrAttachments/373313-Letter - REO - HE15199 - Approval - Addition of Site 10.pdf (Ethics approval)
Attachments [7] 2932 2932 0 0
/AnzctrAttachments/373313-Approval - Addition of Wagga.pdf (Ethics approval)

Contacts
Principal investigator
Name 76310 0
A/Prof Susan Connor
Address 76310 0
Department of Gastroenterology & Hepatology
Clinic 123 Level 1, Liverpool Hospital, Liverpool NSW 2170 Australia

Psycho-Oncology Research Group, Ingham Institute
Liverpool Hospital, Locked Bag 7103. Liverpool BC NSW 1871 Australia
Country 76310 0
Australia
Phone 76310 0
+61 2 8738 4085
Fax 76310 0
+61 2 8738 3094
Email 76310 0
[email protected]
Contact person for public queries
Name 76311 0
Andrew Kim
Address 76311 0
Psycho-Oncology Research Group, Ingham Institute
Liverpool Hospital, Locked Bag 7103, LIVERPOOL BC NSW 1871 Australia
Street: Level 2, Ingham Institute Building, 1 Campbell Street, Liverpool 2170 Australia
Country 76311 0
Australia
Phone 76311 0
+ 61 430 540 998
Fax 76311 0
Email 76311 0
[email protected]
Contact person for scientific queries
Name 76312 0
Andrew Kim
Address 76312 0
Psycho-Oncology Research Group, Ingham Institute
Liverpool Hospital, Locked Bag 7103, LIVERPOOL BC NSW 1871 Australia
Street: Level 2, Ingham Institute Building, 1 Campbell Street, Liverpool 2170 Australia
Country 76312 0
Australia
Phone 76312 0
+61 430 540 998
Fax 76312 0
Email 76312 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


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
EmbaseDevelopment and feasibility of a web-based decision aid for patients with ulcerative colitis: Qualitative pilot study.2021https://dx.doi.org/10.2196/15946
N.B. These documents automatically identified may not have been verified by the study sponsor.