Main objectives are first; to explore the reversibility of restrictions and the importance-participation gaps when AS patients with a high disease activity are treated with anti-TNF-α (adalimumab). Second, to explore the effect of anti-TNF-α (…
ID
Source
Brief title
Condition
- Joint disorders
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A decrease in importance satisfaction gap of social participation areas over
time in AS patients, due to a decrease of the disease burden, caused by
treatment with anti-TNF-α (adalimumab)
Secondary outcome
(2) Understand which disease related and which contextual factors contribute to
the change in restrictions of participation and in the gap between importance
and satisfaction in participation areas. Several new variables will be
assessed, such as: objectively assessed physical activity, body composition,
beliefs/attitude regarding physical activity. (3) Changes in physical activity
and body composition. Furthermore (4), the relation of participation and
satisfaction with life is an important secondary parameter.
Background summary
Participation is a relevant outcome when exploring the impact of chronic
diseases on persons, since it contributes to the individual's autonomy in
society and satisfaction with life. In ankylosing spondylitis (AS) research
concentrated on participation in paid work, but ignored other important areas
of participation such as engagement in physical leisure activities, attending
at social events and maintaining relationships with children, grandchildren and
other family. Moreover, variables contributing to participation and its
relation to satisfaction with life are poorly understood. Among others,
physical activity and body composition (related to disease and physical
activity) have been raised as underestimated factors. Finally, it is not known
to what extent treatment with anti-TNF- α can improve participation and
overall life satisfaction. Insights into these issues will help to improve
holistic management of patients with AS, when, aiming to help them continuing
an autonomous and satisfied life.
Study objective
Main objectives are first; to explore the reversibility of restrictions and the
importance-participation gaps when AS patients with a high disease activity are
treated with anti-TNF-α (adalimumab). Second, to explore the effect of
anti-TNF-α (adalimumab) on physical activity and body composition in AS and
third; examine if they are related to participation.
Study design
9 month prospective cohort (longitudinal) study.
Study burden and risks
Baseline measurements will be compared with outcomes after 12, 24 and 36 weeks.
Online questionnaire will assess all the mentioned outcomes at every point in
the study. Additionally, physical activity (accelerometers) and body
composition (deuterium dilution) will be assessed at baseline and after 36
weeks. All the measurements can be carried out at home or other place of will.
No potential risks are expected.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Have AS according to the New York criteria
- Be under the care of a rheumatologist
- Start TNF inhibitors (adalimumab) as being part of current practice
- BASDAI score of 4 or higher.
- All subjects must be recruited within a period of 1 (one) year from the start of the longitudinal study.
Exclusion criteria
- Have severe non-AS related co morbidity according to the diagnose treatment combination (DBC). Please note that this only applies for patients with a co-morbidity, by whom the treating doctor/rheumatologist decides they should not be included in the study because of health reasons. Patients who suffer from a co-morbidity without a non-immediate health risk will be included. Their situation will be assesses with the SQC questionnaire in order to correct for a confounding effect.
- Have contra-indications (diagnosed by treating rheumatologist/specialist) for TNF inhibition
- Do not understand the Dutch language
- Do not have access to a computer with internet
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 | NL35390.068.11 |