Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000389303
Ethics application status
Approved
Date submitted
10/03/2017
Date registered
16/03/2017
Date last updated
17/09/2021
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Teleconsulting versus normal consulting in the care of inflammatory bowel disease in rural Southern District Health Board patients.
Scientific title
Establishing the role of Teleconsulting in the care of chronic conditions in rural areas of the Southern District Health Board (SDHB): A randomised controlled trial (RCT) in patients with Inflammatory Bowel Disease
Secondary ID [1] 291425 0
Nil known
Universal Trial Number (UTN)
U1111-1194-1395
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 302438 0
ulcerative colitis 302472 0
inflammatory bowel disease 302473 0
Condition category
Condition code
Public Health 302008 302008 0 0
Health service research
Oral and Gastrointestinal 302033 302033 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
The intervention will last 12 months for each participant. Teleconsulting + IBDsmart. Those allocated to the teleconsulting + IBDsmart group will be treated in teleconsulting suites in Dunstan and Queenstown for the duration of the study. Their gastroenterologist will be situated at a teleconsulting unit in Dunedin Hospital. IBDsmart is a previously developed smartphone app that contains validated disease activity indices for IBD patients that can be completed by the patient on their smartphone and sent directly to their gastroenterologist and/or IBD Nurse remotely. A profile containing the patient’s details is generated by the IBD Nurse and IBDsmart is downloaded to the patient’s smartphone. Before each teleconsulting clinic, the patient will send a symptom score from the IBDsmart app on their phone to the gastroenterology unit in Dunedin and the generated report including past scores will be uploaded to Health Connect South. Crohn’s disease (CD) patients will send a Harvey-Bradshaw Index (HBI) and ulcerative colitis (UC) patients will send a Simple Clinical Colitis Activity Index (SCCAI).
The teleconsultations will occur as often as they normally would for the patient (e.g., if the patient is normally seen by their gastroenterologist every six months, each teleconsultation will happen six monthly). Each teleconsultation will be of the normal length of an outpatient appointment (i.e. 15-30 minutes). The teleconsultations will replace normal person-to-person appointments and the content of them will be the same apart from the fact the doctor will not be sitting in the same room as the patient.
Intervention code [1] 297462 0
Treatment: Other
Intervention code [2] 297482 0
Treatment: Devices
Comparator / control treatment
Arm 2:
Those allocated to the standard medical care group will be seen by their gastroenterologist in person for the duration of the study.
Control group
Active

Outcomes
Primary outcome [1] 301434 0
Disease control. Measured by clinical disease activity indices measured at each clinic visit, frequency of clinic visits, number of flare-ups, and frequency of ‘emergency’ consultations.
Timepoint [1] 301434 0
12 months
Primary outcome [2] 301435 0
Disease specific quality of life. Measured using the Inflammatory Bowel Disease Questionnaire (IBDQ) or IBDQ-Stoma. The IBDQ and IBDQ-Stoma contain 32 items divided into 4 health subdimensions: bowel symptoms (e.g., loose stools, abdominal pain; 10 items), systemic symptoms (e.g., fatigue, sleeping problems; 5 items), social functioning (e.g., limited social activity, school, or work attendance; 5 items), and emotional functioning (e.g., irritability, anger, depression; 12 items). The IBDQ and IBDQ-Stoma have a minimum clinically significant change score of 20 points.
Timepoint [2] 301435 0
12 months
Secondary outcome [1] 332639 0
Cost effectivness. A cost-effectiveness analysis comparing teleconsulting + IBDsmart to standard medical care for IBD patients in Central Otago will be conducted from a predominantly societal perspective. Direct costs will comprise service delivery costs including clinician time and travel, clinic, technology costs and additional medical costs such as hospital in-patient care. Indirect costs will include out-of-pocket costs to patients such as GP visits, travel costs and time off work.
Timepoint [1] 332639 0
12 months
Secondary outcome [2] 332640 0
Acceptability. Measured using custom made questionnaires prepared for the Dr and patients in the study.
Timepoint [2] 332640 0
12 months

Eligibility
Key inclusion criteria
1) diagnosed with IBD, 2) aged 18 or older, 3) living rurally, and 4) able to speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
do not have IBD, aged less than 18, not living rurally, and unable to speak English.

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 will be performed by the biostatistician (statistician, who will not be involved in recruitment or screening). A small random component will be incorporated to conceal allocation. Statistician will allocate patients in batches and return these with a non-informative group code (A or B). Statistician will remain blinded to the actual groups until all primary analyses are completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fifty percent of patients will be randomly allocated to the teleconsulting + IBDsmart group and 50% to standard medical care (face-to-face clinics). Allocation will be performed by the biostatistician using minimisation by disease category (CD versus UC, and IBD-unspecified), severity (low-need versus high-need ), and centre.
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
The electronic data will be managed in a password protected database and all physical records will be kept under lock and storage.
The two groups will be compared using regression models examining follow-up outcomes while adjusting for baseline values. Standard regression diagnostics will be performed. Should missing data rates exceed 5%, multiple imputation will be used to generate data sets for data missing (completely) at random (M[C]AR) and plausible scenarios will be examined for missing not at random (MNAR). Analyses will be performed using Stata 14.2 and/or R 3.3.2.
The RCT is designed to demonstrate non-inferiority with 80% power where this is defined by IBDQ scores being less than or equal to 20 pts lower (SD 38), SCCAI scores less than or equal to 3 points lower (SD 3.5) in UC, and HBI scores less than or equal to 3 points lower (SD 4.7) in CD, when using one-sided 95% CI. Without making any assumptions about correlations between baseline and follow-up scores, this will require n=90 participants with IBD at follow-up (for IBDQ), and n=62 with CD and n=34 with UC (for the disease-specific scales). Our previous research suggests that approximately 50% of cases will be CD, 40% UC, and 10% indeterminate colitis and so of the approximately 100 IBD patients living in Central Otago, assuming 80% enrolment and that loss to follow-up over the year is less than or equal to 5%, we would expect approximately 75 IBD patients (40 CD, 35 UC) with full data. As the study cannot be performed as a fully-powered RCT within the region (limited number of patients), we will perform an interim analysis after one year to determine whether to expand the study to other centres to achieve the required sample size. This analysis will only proceed once a full statistical analysis plan has been produced and the results from the interim analysis will not be published if recruitment continues. As a conservative approach, we will consider the study futile and not attempt further recruitment should the 95% confidence intervals for each outcome be strictly below the non-inferiority limits and otherwise perform the non-inferiority analyses on the final data set without further adjustment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2017
Actual
7/08/2017
Date of last participant enrolment
Anticipated
30/06/2019
Actual
15/04/2020
Date of last data collection
Anticipated
30/06/2020
Actual
15/04/2021
Sample size
Target
75
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 8735 0
New Zealand
State/province [1] 8735 0
Otago

Funding & Sponsors
Funding source category [1] 295894 0
Government body
Name [1] 295894 0
Southern District Health Board Health Service Delivery Research Grant
Country [1] 295894 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medicine
University of Otago, Dunedin
362 Leith St
North Dunedin
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 294765 0
None
Name [1] 294765 0
None
Address [1] 294765 0
None
Country [1] 294765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297173 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 297173 0
Ethics committee country [1] 297173 0
New Zealand
Date submitted for ethics approval [1] 297173 0
17/03/2017
Approval date [1] 297173 0
02/06/2017
Ethics approval number [1] 297173 0

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

Contacts
Principal investigator
Name 73230 0
Ms Christine Ho
Address 73230 0
Clinical IBD Nurse Specialist
Department of Gastroenterology
Dunedin Hospital
201 Great King St,
Dunedin 9016
Country 73230 0
New Zealand
Phone 73230 0
+64275554438
Fax 73230 0
Email 73230 0
[email protected]
Contact person for public queries
Name 73231 0
Michael Schultz
Address 73231 0
Gastroenterologist,
Department of Medicine,
University of Otago, Dunedin
PO Box 56
Dunedin 9054
Country 73231 0
New Zealand
Phone 73231 0
+64276102395
Fax 73231 0
Email 73231 0
[email protected]
Contact person for scientific queries
Name 73232 0
Michael Schultz
Address 73232 0
Gastroenterologist,
Department of Medicine,
University of Otago, Dunedin
PO Box 56
Dunedin 9054
Country 73232 0
New Zealand
Phone 73232 0
+64276102395
Fax 73232 0
Email 73232 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1190Ethical approval    372543-(Uploaded-29-01-2019-12-05-19)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMobile technologies to support healthcare provider to healthcare provider communication and management of care.2020https://dx.doi.org/10.1002/14651858.CD012927.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.