|- candidate number||6428|
|- NTR Number||NTR1993|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-sep-2009|
|- Secondary IDs||80-82605-98-058 Zonmw|
|- Public Title||A computer-based intervention to help COPD patients improve their lifestyle.|
|- Scientific Title||Disease management of COPD and information technology to improve patient self management.|
|- hypothesis||Does computer tailored feedback improve the lifestyle of COPD patient?|
|- Healt Condition(s) or Problem(s) studied||Electronic health record, Diseasemanagement, Lifestyle intervention|
|- Inclusion criteria||COPD patients, who are treated by a general practitioner, according to the DBC protocol for COPD.|
|- Exclusion criteria||1. COPD patients, who are treated by the medical specialist;|
2. Receive care by public health nurses;
3. Patients who have an insufficient command of the Dutch language.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||15-feb-2010|
|- planned closingdate||15-jun-2010|
|- Target number of participants||48|
|- Interventions||The self help manager is a computer program that provides the patient with feedback. The patient will fill in a questionnaire and the responses to the questions will yield a specific advice. |
|- Primary outcome||The main outcome measures are:|
1. The observed levels of self management and use of information technology at 1 year;
2. The percieved benefits for care, self-management, and organization at 1 year;
3. The estimated costs and benefits of a full implementation at 1 year.
|- Secondary outcome||The optimal frequency of reminders for continuing the system use at 1 year.|
|- Timepoints||1 year.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| H. Tange|
|- CONTACT for SCIENTIFIC QUERIES|| H. Tange|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The goal of this project is to improve the self management of COPD patients with the help of information
technology as part of a disease-management approach. We will integrate two existing evidence-based methods to realize this goal. The first method is a disease-management approach with EPR support that has been validated for diabetes care. The second method is a computer-tailored feedback approach for patient self management that has been validated for smoking and physical activity. Both methods have been developed at University Maastricht.
In the Maastricht region a Diagnosis-Treatment Combination (DBC) reimbursement system for COPD
will be implemented in 2008. This DBC is based on our validated disease-management approach. In this proposal we will enrich this program by an intervention in which we provide the COPD-patient with computer-tailored feedback between consultations.
We will assess the feasibility of this intervention by conducting a pilot study in which we examine the effects on (1) patient self management and (2) the organization of care; (3) the use and appreciation of the information technology; (4) the costs and benefits of a full implementation. The study has a pre-post design with process measurement during the intervention. We recruit 48 COPD-patients equally divided over 4 general practitioners. Main outcome measures are (1) the observed levels of self management and use of information technology; (2) the perceived benefits for care, self-management, and organization; (3) the estimated costs and benefits of a full implementation. Data sampling takes place by a web-based questionnaire, physician consultation, information-system logging, in-depth interviews, and focus groups. Within the pilot we conduct a small experiment to compare different frequencies to remind the patient to revisit the computer-tailoring system. For this experiment we use a balanced-block design with three blocks of four patients per general practitioner. At the end of the project the results are commented by an expert panel and recommendations are given about the optimization of the EPR infrastructure.
|- Main changes (audit trail)|
|- RECORD||8-sep-2009 - 12-okt-2009|