|- candidate number||14711|
|- NTR Number||NTR3947|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-apr-2013|
|- Secondary IDs||42467 ABR|
|- Public Title||PORTALS.|
|- Scientific Title||PORtal implementation within anTicoagulation care; AmpLification of Selfmanagement (PORTALS).|
|- hypothesis||Implementation of online patient portals with higher levels of personal assistance will result in increased use and increase impact of the portals on clinical benefits and well-being. |
|- Healt Condition(s) or Problem(s) studied||Thrombosis|
|- Inclusion criteria||1. At least 6 months usual care from the
2. In need of long-term Anticoagulant
Therapy (>6 months);
3. Internet access.
|- Exclusion criteria||1. Patients who already use self-
management for thrombosis;|
2. Instable patients according to judgment of
physicians of the Thrombosis Service;
3. Patients who are unable to complete
4. Patients with terminal illness;
5. Patients with severe substance abuse;
6. No internet access.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2013|
|- planned closingdate||31-dec-2016|
|- Target number of participants||534|
|- Interventions||Participants who wish to start with self-management will be randomly selected in a study group for e-learning (group 1) or for face to face group training (group 2). Both groups will be trained in general knowledge on thrombosis, self testing, self dosage of medications (optional) and registration in and use of the online patient portal. Patients in the non-self-management group (group 3) receive regular care. |
|- Primary outcome||Clinical effects expressed in blood clotting speed (Time in Therapeutic Range; TTR). |
|- Secondary outcome||The number of thromboembolic events and bleedings.|
|- Timepoints||For research goals, patients are asked to fill in questionnaires every six months during a period of 1,5 years. |
|- Trial web site||www.saltro.nl|
|- CONTACT FOR PUBLIC QUERIES|| N.H. Chavannes|
|- CONTACT for SCIENTIFIC QUERIES|| N.H. Chavannes|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center, Department of Public Health and Primary Care (PHPC)|
|- Brief summary||Rationale: The number of patients in need of thrombosis management is increasing. Self-management may help to provide accessible health care but costs are high due to ineffective health care processes. Evidence based improvements of efficiency and quality in health care processes and in clinical outcomes have been reported for online automated monitoring systems (patient portals). However, sustainable realization in daily practice stays behind. Insights in optimal implementation methods in large real-life primary care populations are needed for successful integration in practice. |
Objective: The main aim is to investigate clinical effects of different implementation methods of online supported self-management for thrombosis patients in primary care. Secondary objectives include effects on well-being, health care use and actual use of the portal. Differences in users’ satisfaction will be investigated as tertiary goals. Patient characteristics will be investigated as determinants for actual use of the portal.
Study design: parallel cohort study.
Study population: In this study two different implementation methods will be compared, each conducted in a separate research group of patients who are willing to start with self-management. Additionally, a third research group will be included, existing of non-self-management participants who wish to continue regular care. For significant differences in TTR (Time in Therapeutic Range) (>3.5%) at power 80% and α = 0.05, 142 patients must be included per group. Taking into account 20% drop out,5 178 (142/0.80) patients are needed per study group. Hence, three research groups of 178 patients each will be included from the Saltro Thrombosis Service. All eligible patients currently receive regular Anticoagulation Care.
Intervention: participants who wish to start with self-management will be randomly selected in a study group for e-learning (group 1) or for face to face group training (group 2) or. Both groups will be trained in general knowledge on thrombosis, self testing, self dosage of medications (optional) and registration in and use of the online patient portal. Patients in the non-self-management group (group 3) receive regular care.
Main study parameters/endpoints: the main endpoint is clinical effects expressed in blood clotting speed (Time in Therapeutic Range; TTR); TTR is based on daily measurements. Second main endpoint is the number of thromboembolic events and bleedings, which is also based on daily reports.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Saltro Thrombosis Service provides Anticoagulation Care since 2000 and currently includes over 10,000 patients. Nowadays Saltro provides two types of care programs: regular care and self-management without online support. Both programs are grounded on evidence based national guidelines (FNT)12 and have received objective quality labels. Professionals of the Saltro Thrombosis Service Centre are in control of the safety of all patients on daily base: deviations in TTR, medication or other determinants are automatically and daily sent to the professionals to guarantee safety of all patients. Additionally, self-management patients are controlled two times a year for self-testing and self-dosage skills and for validation of the self-testing device. Comparable self-management programs are broadly accepted and being used by other Thrombosis Services without report of adverse events, despite lack of evidence based support.
In this study, the current self-management program will be extended with online support and - in study group 1- with e-learning. The e-learning implementation method will be compared with face-to-face group training (study group 2). E-learnings for thrombosis patients are being used with satisfaction by other Thrombosis Services. The group sessions are already of the current self-management program of Saltro Thrombosis Centre, as has been described above. Patients who wish to start with self-management but who do not want to participate in the study will be included in the group training sessions as well. Patients who do not wish to start with self-management continue to receive regular care and will be invited to participate in study group 3 for research purposes.
For research goals, patients are asked to fill in questionnaires every six months during a period of 1,5 years. The questionnaires will be provided online and take between 10-20 minutes to complete. After replying the first and last set of questionnaires, participants will receive gift cards (€25,- and €50,-) as a reward. This study is important as current care processes can be improved in favor of patients by its results.
Participants are free to withdraw from the study any moment without specification of reasons. This will not affect continuity of care. Furthermore, specialists of the Saltro Thrombosis Service can decide to withdraw subjects from the e-learning group or the study for urgent medical reasons.
|- Main changes (audit trail)|
|- RECORD||11-apr-2013 - 1-jun-2017|