|- candidate number||14919|
|- NTR Number||NTR4009|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mei-2013|
|- Secondary IDs||P12-164 METC LUMC|
|- Public Title||PRACTISS COPD|
|- Scientific Title||Pulmonary Rehabilitation of COPD: a trial of sustained internet based self-management support |
|- hypothesis||We hypothesized that self-management support via an internet based service in addition to usual care is (cost)effective in patients with COPD who have completed pulmonary rehabilitation.|
|- Healt Condition(s) or Problem(s) studied||COPD|
|- Inclusion criteria||1) Pulmonologist-diagnosed COPD (FEV1/FVC < 0.7);|
2) COPD as the most important limiting factor;
3) Completion of an initial rehabilitation programme.
|- Exclusion criteria||1) Not being able to use a computer correctly;|
2) Serious psychological problems that need referral to a psychologist after completion of the rehabilitation programme.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2013|
|- planned closingdate||1-feb-2015|
|- Target number of participants||100|
|- Interventions||In addition to usual care patients in the internet-based self-management support group will be provided with self-management support via PatientCoach up until one year after completion of the rehabilitation program at . The PatientCoach self-management support tools are available to guide discussion between care providers and patient in such a way that the patient determines his or her goal, identifies steps to achieve the goal, identifies barriers to reaching the goal, and plans for overcoming the barriers, including obtaining needed resources.
Control group will receive usual care.
|- Primary outcome||Health Related Quality of Life (Chronic Respiratory disease Questionnaire)|
|- Secondary outcome||o Clinical control; |
o Exercise capacity;
o Actual activity;
o Lung function;
o Self-management skills and health education impact;
o Illness perceptions;
o Patient utilities;
|- Timepoints||Baseline, 3,6,9 and 12 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Jacob K. Sont|
|- CONTACT for SCIENTIFIC QUERIES|| Jacob K. Sont|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Netherlands Asthma Foundation|
|- Brief summary||Background of the study:|
The effectiveness of pulmonary rehabilitation on exercise capacity and quality of life is well-established in COPD1. Pulmonary rehabilitation should be part of an integrated care process and include self-management support. Changing patient behaviour and ensuring maintenance are complex processes and require time. Currently, most programs take between six and 12 weeks and a longer duration is associated with greater improvements in physical and psychological functioning2. However, there are sparse data on whether the benefits are sustained beyond completing pulmonary rehabilitation and patients are not always amenable to
optimal self-management in their own environment after completing pulmonary rehabilitation1. Identification of patients who may have difficulty maintaining and implementing appropriate self-management behaviour during and after the rehabilitation program may offer clues to improve long-term outcomes3. In order to achieve a sustained long-term improvement in quality of life we need a dependable system of coordinated health care interventions and communication, and components that include self-management support.
Innovative forms of self management support including an online community, monitoring, communication, an action plan and Motivational feedback via internet have high potential to improve long-term outcomes.
Recently, a pilot randomised trial in stable, optimised COPD patients who had already completed pulmonary rehabilitation showed that telemonitoring in addition to best care reduced primary care contacts concerning pulmonary complaints4. Another pilot-study showed that cell phone-based exercise persistence and coaching intervention to patients with COPD post-rehabilitation is feasible5. In chronic heart failure (CHF) a recent Cochrane review showed that structured telephone support and telemonitoring reduces the risk of all-cause mortality and CHF-related hospitalisations, improves quality of life and reduces costs6. In asthma, we have recently demonstrated that internet-based self-management support improves quality of life, the number of symptom-free days and clinical outcomes7. To date, the long-term effectiveness of sustaining self-management support via internet in patients with COPD who have completed pulmonary rehabilitation has not been determined yet.
- To assess the one-year effectiveness and cost-effectiveness of sustaining self-management support via an internet-based service in addition to usual care as compared to usual care alone a pragmatic trial in patients with COPD who have completed pulmonary rehabilitation;
- To identify predictors of successful self-management support and quality of life;
- To unravel the relationship between patient characteristics, process outcomes and quality of life.
The study is designed as a parallel-group randomised pragmatic trial with 1 year of follow-up.
100 Patients with COPD who have completed the rehabilitation program at the RRC will be included in this study.
Intervention (if applicable):
Control-group will receive usual care. Intervention group will receive self-management support via internet using the PatientCoach-platform during one-year of follow-up additional to usual care.
Primary study parameters/outcome of the study:
Health related quality of life.
Secondary study parameters/outcome of the study:
Clinical control; exercise capacity; actual activity; lung function;
self-management skills and health education impact; illness perceptions; patient utilities; exacerbations; costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
At baseline and after one year of follow-up all patients will perform a shuttle walk test and spirometry.
Patients in the intervention group will be familiarized with PatientCoach shortly after randomization. Every three months all participants will digitally receive a set of questionnaires which can be filled out using a personal computer with internet connection. Throughout the follow-up year patients in the intervention group will be encouraged to wear an activity monitor daily to gain insight in their physical activity pattern.
|- Main changes (audit trail)|
|- RECORD||27-mei-2013 - 4-jun-2013|