De Jong 2017.
Study characteristics | ||
Methods |
Study design: "pragmatic" randomised controlled trial Study duration: 9 September 2014 to 18 May 2015 Setting: conducted at four hospitals in the Netherlands: two academic hospitals (Maastricht University Medical Centre and Leiden University Medical Centre), and two large, non‐academic regional hospitals (Zuyderland Medical Centre, Sittard and St Antonius Hospital, Nieuwegein). |
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Participants |
State of disease at beginning of study per IG/CG: baseline disease activity:
IG: remission 394 (85%), active disease 71 (15%) CG: remission 380 (86%), active disease 64 (14%) Disease type per IG/CG: IG: 282 (61%) CD patients, 183 (39%) UC patients CG: 262 (59%) CD patients, 182 (41%) UC patients Inclusion criteria: IBD patients, between 18 and 75 years, fulfilling the international diagnostic criteria for inflammatory bowel disease Exclusion: all IBD patient who were not able to read or understand the informed consent form, and did not have Internet access by computer, tablet, or Smartphone or patients with a hospital admission within 2 weeks before inclusion were excluded for ethical reasons, because these patients were deemed unable to make an informed decision for participation. Patients with an ileoanal pouch or ileorectal anastomosis were also excluded. Age at beginning of study per IG/CG: mean age in years (SD) IG: 44.0 (14.1) CG: 44.1 (14.2) Sex per IG/CG: IG: Number of males (%): IG 194 (42%); CG 180 (41%) Number of females (%): IG 271 (58%); CG 264 (59%) Disease duration per IC/CG: mean (SD) years IG: 12.8 (10.4); CG: 13.1 (10.8) Number randomised per IG/CG: IG: 465; CG: 444 Number reaching end of study per IG/CG: IG: 438; CG: 443 |
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Interventions |
Telemedicine or myIBDcoach in the intervention group (IG) versus standard care in the control group (CG) IG: participants received instructions, a username, and a password for a telemedicine system (myIBDcoach), which included intensified monitoring modules (weekly in case of flare), outpatient visit modules (to prepare for an outpatient visit), e‐learning modules, a personal care plan, and an administrator page used by the healthcare provider (i.e. gastroenterologist or nurse). Participants used the system for 12 months and were instructed to plan at least one routine outpatient visit per year. Additional follow‐up visits were scheduled on the basis of alarm symptoms recognised by the telemedicine system or at the requests of individual patients. CG: participants continued their routine follow‐up visits following the local protocol, with the opportunity to schedule an extra visit if symptoms relapsed. At baseline and after 12 months all participants received a paper questionnaire regarding perceived quality of care, medication adherence, quality of life, self‐efficacy, disease‐related and medication‐related knowledge, and smoking behaviour. |
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Outcomes |
Primary outcomes: number of outpatient visits and patient‐reported quality of care. The number of outpatient visits and telephone consultations with gastroenterologists and nurses during the 12‐month period were retrieved from patients’ electronic medical records. Secondary outcomes: adherence to treatment, quality of life, self‐efficacy, disease‐related and medication‐related knowledge, smoking behaviour, and disease outcomes. |
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Notes |
Funding: supported by an academic incentive fund of the Maastricht University Medical Centre (31962340B). MyIBDcoach was developed by Sananet BV using an unrestricted grant from Ferring. The funding source had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Declaration of interests: MJdJ reports non‐financial support from Merck Sharpe & Dohme, outside the submitted work. AEvdM‐dJ reports grants and non‐financial support from Takeda, personal fees from AbbVie, and non‐financial support from Tramedico, all outside the submitted work. AAvB reports personal fees from AbbVie, MSD, Ferring, Tramedico, Takeda, Pfizer, and Janssen, all outside the submitted work. GD reports speaker’s fees from Shire, AbbVie, and Takeda, and a grant for investigator‐initiated research from Takeda, all outside the submitted work. AAM reports grants from Grünenthal, Zon MW GGG (government), Will Pharma, BioActor, Pentax Europe, Falk Pharma, and Almiral Pharma, all outside the submitted work. AB received research grants to her department from AbbVie, Amgen, and Merck, and advisory board honoraria from Janssen and Sandoz, all unrelated to the current work. MJP reports personal fees from AbbVie, Ferring, Janssen, and Takeda, and grants from Falk, all outside the submitted work. All other authors declare no competing interests. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using ALEA Screening and Enrolment Application Software where patients were randomly assigned (1:1) to care via the telemedicine system (intervention) or standard care (control). |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment. We contacted the author, and they responded "Participants, health‐care providers, and staff who assessed outcome measures were not masked to treatment allocation" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, healthcare providers, and staff who assessed outcome measures were not masked to treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention of any outcome assessment blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The telemedicine follow‐up group lost 27/465 and the routine follow‐up group lost 1/444. There is a detailed explanation of the reasons for patients withdrawing and we think the reasons are appropriate given what each group received and there's no major imbalance that will affect the outcomes. |
Selective reporting (reporting bias) | Low risk | This trial was registered at ClinicalTrials.gov (NCT02173002) and appropriate outcomes reported as per method section. |
Other bias | Low risk | No baseline imbalances and no other concerns. |