The main aim is to investigate clinical effects of different implementation methods of online supported self-management for COPD patients in primary care. Secondary objectives include effects on well-being, health care use and actual use of the…
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is change of health status (CCQ) of primary care COPD
patients who received an online supported self-management program, with
different implementation methods. We expected that higher levels of personal
assistance will result in better selfmanagement and improve health stuatus .
Secondary outcome
Secondary outcomes are the effects of different implementation methods of the
selfmanagement program on general quality of life, health care use and actual
use of the online patient portal.
Background summary
The number of patients in need of COPD 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.
Study objective
The main aim is to investigate clinical effects of different implementation
methods of online supported self-management for COPD 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
This study encludes a parallel cohort design. The clinical effects will be
measured according to interrupted time series (ITS) design.
Intervention
Participants who wish to start with self-management will be supported with an
online platform for group A and B, called eVita COPD patient platform. This
platform enables patients to manage their own health and disease. The COPD
platform is integrated in a patient platform (eVita platform) for chronic
diseases (diabetes, heart failure and COPD) that is developed by health care
professionals, ICT professionals and (COPD) patients. Patients in group A and B
will be randomly divided in 2 subgroups after inclusion. Patients in subgroup
A1 and B1 will be individually supported to use the online patient portal by an
account manager in face-to-face (A1) or telephone contacts (B1). Subgroups A2
and B2 will not receive additional support from an account manager. For COPD
patients in group C a more simple portal will be provided by Saltro Diagnostic
Centre, with basic information of COPD and individualized test results.
Study burden and risks
General Practitioners in the three primary care cooperations that will
parcticipate in this study provide COPD care since many decades. The care
programs are grounded on evidence based national guidelines and have received
objective quality labels. Professionals of the primary care cooperations are in
control of the safety of all patients on daily base: deviations in CCQ,
medication or other determinants are automatically and daily sent to the
professionals to guarantee safety of all patients. Comparable self-management
programs are broadly accepted and being used by other professionals without
report of adverse events, despite lack of evidence based support.
For research goals, patients are asked to fill in questionnaires every three
months during a period of 15 months. 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 (¤30 in total) as a
reward. This study is important as current care processes can be improved in
favor of patients by its results.
Patients who do not wish to start with self-management continue to receive
regular care. Participants are free to withdraw from the study any moment
without specification of reasons. This will not affect continuity of care.
Furthermore, professionals within the cooperations can decide to withdraw
subjects from the study for urgent medical reasons.
Hippocratespad 21
Leiden 2333 RC
NL
Hippocratespad 21
Leiden 2333 RC
NL
Listed location countries
Age
Inclusion criteria
COPD patients according to GOLD criteria (post-bronchodilator FEV1/FVC<0.7)
Exclusion criteria
patients who are unable to fill in questionnair
patients that have no access to internet
patients with terminal illness
severe immobile patients
patients with severe substance abuse
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 | NL44486.058.13 |