|- candidate number||14468|
|- NTR Number||NTR3910|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2013|
|- Secondary IDs||P12.168 METC LUMC|
|- Public Title||PRACTISS Asthma.|
|- Scientific Title||Pulmonary Rehabilitation of Asthma: A Trial of sustained Internet based Self-management Support.|
|- hypothesis||We hypothesize that selfmanagement support via an internet based service in addition to usual care will improve health related quality of life in patients with severe asthma who have participated pulmonary rehabilitation in specialized asthma clinics. |
|- Healt Condition(s) or Problem(s) studied||Asthma|
|- Inclusion criteria||1. Pulmonologist-diagnosed severe persistent, difficult to treat asthma asthma;|
2. Patients with asthma as the most important limiting factor;
3. Participated in rehabilitation to Davos or Heideheuvel because previous optimal treatment did not lead to adequate asthma control, and completed at least two third of the initially determined rehabilitation programme;
4. Access to internet at home and able to use it.
|- Exclusion criteria||1. Serious psychological problems that may interfere with compliance or reliability of the measurements;|
2. Relevant somatic or psychiatric co-morbidity that interferes with the study.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-feb-2013|
|- planned closingdate||1-feb-2015|
|- Target number of participants||100|
|- Interventions||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. This self-management support (PatientCoach website www.patientcoach.nl) comprises:
1. Asthma control self-monitoring (Asthma Control Questionnaire);
2. Lung function self-monitoring (FEV1 measured by PIKO device);
3. Activities monitoring (measured by FitBit device);
6. Medical news;
This support aims to improve health related quality of life.
|- Primary outcome||Health related quality of life (Asthma Quality of Life Questionnaire).|
|- Secondary outcome||Lung function, physical activity, self-management skills, health education impact, illness perceptions, exacerbations, patient utilities and costs.|
|- Timepoints||Duration 12 months.|
Questionnaires at 0, 3, 6, 9, 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:|
Patients are not always amenable to optimal self-management in their own environment after completing pulmonary rehabilitation. In order to achieve sustained quality of life improvement 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. However, the long-term effectiveness of sustaining self-management support via internet in patients with severe asthma who have completed pulmonary rehabilitation has not been determined yet.
Objective of the study:
To assess the one-year (cost)effectiveness of self-management support via an internet-based service in addition to usual care as compared to usual care alone in a pragmatic trial in patients with severe asthma who are referred for a pulmonary rehabilitation programme. In addition, we will identify predictors of successful self-management support and quality of life outcomes and unravel the relationship between patient characteristics, process outcomes and quality of life.
Pragmatic Randomised Controlled Trial.
Patients with severe asthma who are referred for a rehabilitation programme at the high-altitude center Davos or asthma center Heideheuvel and own a personal computer with an internet connection are eligible to take part in this study.
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:
Lung function, physical activity, self-management skills, health education impact, illness perceptions, exacerbations, patient utilities and costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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||6-mrt-2013 - 1-apr-2013|