|- candidate number||27818|
|- NTR Number||NTR6693|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2017|
|- Secondary IDs||2017-3625 Interreg Europe, European Union; European Regional Development Fund|
|- Public Title||Grensoverschrijdende Online behandeling van Artrose / Beyond borders: e-self-management for knee and/or hip osteoarthritis (dr. Bart - app).|
|- Scientific Title||Beyond borders: e-self-management for knee and/or hip osteoarthritis (dr. Bart - app).|
|- ACRONYM||Dr. Bart - app |
|- Healt Condition(s) or Problem(s) studied||Arthrosis, Coxarthroses, Gonarthrose, Selfmanagement|
|- Inclusion criteria||- ≥50 years of age|
- Self-reported OA of the knee and/or hip
- Able to read, write and sufficiently comminucate in Dutch or German language, where appropiate
- Possession of smartphone or tablet and willing to download the Dr. Bart app on one or more devices
- Having an email address
|- Exclusion criteria||- Being wheelchair bound|
- Knee and / or hip replacements
- Scheduled for replacement surgery in the next 6 months
- Diagnosis of inflammatory rheumatic disease
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-dec-2017|
|- planned closingdate||31-dec-2019|
|- Target number of participants||483|
|- Interventions||Dr. Bart - application |
|- Primary outcome||Number of consultations in secondary healthcare (e.g. orthopaedic surgeon / rheumatologist) due to OA of the knee and/or hip in the past 6 months. |
|- Secondary outcome||- Health care consumption|
- Self-management behaviour
- Physical activity
- Treatment Beliefs in Osteoarthritis
- Physical function in daily living, sport and recreation
- Health status
- Illness perception
- Quality of care
- Usability of the app
- Use of the app
|- Timepoints||Assessments will be performed at baseline and after 3 and 6 months via internet questionnaires. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Tim Pelle|
|- CONTACT for SCIENTIFIC QUERIES|| Tim Pelle|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|European Regional Development Fund, Interreg Europe|
|- Brief summary||Rationale: Osteoarthritis (OA) is highly prevalent in industrialized countries. It is expected that this number will expand through aging and higher BMIs. Since OA is not curable, a rich variety of and non-surgical (conservative) and surgical treatments are available. The American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) recommend a combination of pharmacological and non-pharmacological modalities (i.e. education, exercise and pain management). As OA is a chronic disease, self-management is of paramount importance. Modern technologies offer the possibility to support self-management, for instance by providing interactive information 24/7, as well as tools to set goals and monitor life-style changes. A wide variety of apps is available for a variety of chronic diseases (i.e. COPD, Diabetes Mellitus). However, hardly no empirical supported OA apps are available. Therefore, we developed an online self-management app (Dr. Bart) with the aim to enhance self-management and ultimately to optimize non-surgical health care utilization and to reduce secondary health care costs in patients with knee and / or hip OA (KHOA). This app will be implemented simultaneously in the region of Nijmegen (the Netherlands) and Meerbusch (Germany), to allow to examine the influence of cultural differences on the use of self-management. We hypothesize that the app is superior to usual care.|
Objective: The primary objective of this study is to investigate the effect of the dr. Bart - app on the number of consultations in secondary healthcare in patients with KHOA in the Netherlands in the six month period of follow up. Secondary objectives are: to examine short and long term (3 & 6 months) effects on clinical outcomes attributable to the app; to observe the use and usability of the app; to explore differences in use, usability and clinical outcomes between the Netherlands and Germany.
Study design: Randomized Controlled Trial (RCT), with two arms in the Netherlands. To study differences in use, usability and clinical outcomes between the Netherlands and Germany we will include a third arm, consisting of patients recruited in Germany, all receiving the app.
Study population: Residents of the region Nijmegen (Netherlands) and Meerbusch (Germany) of 50 years and over, with self-reported KHOA will be recruited through advertisements in local papers.
Intervention: The intervention consists of the provision of the application “dr. Bart”.
Main study parameters/endpoints: Self-reported number of consultations in secondary healthcare, due to KHOA in the 6 months period of follow up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants in the experimental group will be invited to use the app. All participants will receive electronic questionnaires via the software application Castor at baseline, after 3 and 6 months. It will take approximately 30-35 minutes to complete those questionnaires.
Risk attributable to use of the app is not foreseen.
|- Main changes (audit trail)|
|- RECORD||4-sep-2017 - 21-sep-2017|