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PRACTISS Asthma.


- candidate number14468
- NTR NumberNTR3910
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2013
- Secondary IDsP12.168 METC LUMC
- Public TitlePRACTISS Asthma.
- Scientific TitlePulmonary Rehabilitation of Asthma: A Trial of sustained Internet based Self-management Support.
- ACRONYMPRACTISS
- hypothesisWe 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) studiedAsthma
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-feb-2013
- planned closingdate1-feb-2015
- Target number of participants100
- InterventionsControl-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);
4. Diary;
5. Education;
6. Medical news;
7. Forum.
This support aims to improve health related quality of life.
- Primary outcomeHealth related quality of life (Asthma Quality of Life Questionnaire).
- Secondary outcomeLung function, physical activity, self-management skills, health education impact, illness perceptions, exacerbations, patient utilities and costs.
- TimepointsDuration 12 months.
Questionnaires at 0, 3, 6, 9, 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jacob K. Sont
- CONTACT for SCIENTIFIC QUERIES Jacob K. Sont
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Asthma Foundation
- PublicationsN/A
- Brief summaryBackground 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.

Study design:
Pragmatic Randomised Controlled Trial.

Study population:
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.

Intervention:
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)
- RECORD6-mrt-2013 - 1-apr-2013


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