None listed
Conditions
Brief summary
Crohn’s disease and ulcerative colitis, collectively called inflammatory bowel disease (IBD), are chronic conditions that fluctuate in severity over time; IBD is characterized by episodes of remission but also flare-ups when patients need urgent specialist attention. Research has shown that rural care for IBD patients can be suboptimal. We have developed a patient smartphone application called IBDsmart that allows direct interaction with a specialist at any time for disease monitoring but real time face-to-face contact is often still warranted. Teleconsulting allows remote but real time face-to-face patient-specialist contact. This study aims to perform a randomized controlled trial evaluating the role of teleconsulting in IBD management for rural patients residing in Central Otago, New Zealand. Patients residing in Central Otago will be randomly allocated to teleconsulting + IBDsmart versus standard medical care and comparisons will be made in terms of disease control, quality of life and economic sustainability. The primary hypothesis is that disease control and disease specific QoL will be non-inferior in the teleconsulting + IBDsmart group relative to the standard medical care group. Secondarily, it is hypothesized that teleconsulting + IBDsmart will be cost effective, and feasible and acceptable to doctors and patients . If successful, this can be extended into other locations and diseases.
Interventions
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 smar
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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) diagnosed with IBD, 2) aged 18 or older, 3) living rurally, and 4) able to speak English.
Exclusion criteria
do not have IBD, aged less than 18, not living rurally, and unable to speak English.
Outcome results
None listed