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 well-being, health care use and actual use of the portal.…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical effects:
1. blood clotting speed (INR) expressed as Time in Therapeutic Range (TTR)
2. number of thromboembolic events
Secondary outcome
Secondairy outcomes:
1. well being / quality of life
2. health care use
3. use of the portal
Tertiairy outcomes
1. users' satisfaction
2. user profiles
Background summary
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 selfmanagement 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.
Study 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 well-being, health care use and actual use
of the portal. Differences in user profiles and user satisfaction will be
investigated as tertiary goals.
Study design
This research will be performed using a parallel cohort study.
Intervention
Participants who start with self-management will be randomly selected in a
study group for face to face group training or in a study group for e-learning.
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 control group receive usual care.
Study burden and risks
All patients will receive an online supported self-management program. Although
not evidence based, this program is being used by other Thrombosis Services
without report of adverse events. Included patients will be trained in
self-management by e-learning or group sessions. E-learnings for thrombosis
patients are already used with satisfaction by several other Thrombosis
Services. The group sessions are part of the current self-management program of
Saltro Thrombosis Centre that has been provided since 2010 according to
national guidelines and with objective quality label.
According to national quality standards, all patients act under daily
supervision of specialists of the Thrombosis Centre to monitor deviations in
clinical values. Additionally, they are controlled two times a year for
self-testing and self-dosage skills and to validate the self-testing device.
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 as a reward.
Furthermore, current care processes can be improved for patients by results of
this study.
Patients who do not wish to start with self-management receive care as usual.
They will be invited to participate in the control group for research purposes.
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. Professionals from the Saltro Thrombosis Service Centre can decide to
withdraw a subject from the e-learning group or the study for urgent medical
reasons.
Hippocratespad 21
Leiden 2333 RC
NL
Hippocratespad 21
Leiden 2333 RC
NL
Listed location countries
Age
Inclusion criteria
Under control for regular care by Saltro Thrombosis Service for at least the past 6 months
Longterm anticoagulant therapy
Stable clinical values for at least past 6 months
Internet acces (with exception of control group)
Exclusion criteria
Less than six months regular support by Saltro Thrombosis Service
Shortterm indication for anticoagulant therapy
Instable clinical values during last 6 months
No internet acces (with exception of control group)
Inability to complete questionnaires
Severe terminal illness, substance abuse or immobility
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL42647.058.12 |