The primary objective of this pilot trial is to explore the difference between the intervention and control group in change from baseline (T0) to the end of therapy (T1) in therapy efficacy of the primary study outcome fatigue assessed by Checklist…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the difference between the intervention and control group
in change from T0 to T1 in the primary study outcome fatigue (CIS-8 score).
This difference will be reported as descriptive and will be preliminary
statistically tested.
Secondary outcome
In the same way will be explored: secondary therapy efficacy outcomes and
circadian entrainment outcomes as well as follow-up effects (changes from T0 to
T2). Also, the mediating role of circadian entrainment and depression on
therapy efficacy will be explored. We also report the relevant parameter
estimates and variances needed to design a possible future full-scale RCT
(Feeley et al., 2009).
Background summary
Although large progress has been made in the diagnosis and treatment
possibilities for patients with rheumatoid arthritis (RA), RA is often
associated with symptoms which reduce quality of life negatively, including
fatigue. Unfortunately, treatments for these symptoms are currently not for all
patients adequate and many symptoms are left untreated. A disturbed circadian
rhythm (i.e. 24-hour rhythm) has been found in patients with RA and may be an
important underlying mechanism for those symptoms. Bright light can possibly
restore circadian rhythmicity in RA as it is the most important synchronizer of
this rhythm. In the current study, the efficacy of a 4-week Bright Light
Therapy (BLT) program will be examined for the first time in patients with RA.
The current study is a pilot study that could serve as preparation for a future
larger full-scale randomized controlled trial (RCT).
Study objective
The primary objective of this pilot trial is to explore the difference between
the intervention and control group in change from baseline (T0) to the end of
therapy (T1) in therapy efficacy of the primary study outcome fatigue assessed
by Checklist Individual Strength (CIS-8).
As a secondary objective, we will also explore the following therapy efficacy
outcomes: pain and morning joint stiffness (Impact of Rheumatic diseases on
General health and Lifestyle; subscale Pain), sleep (diary and Insomnia
Severity Index), and emotional well-being and general health status (RAND-36),
depression (Hospital Anxiety and Depression Scale), and disease activity
(Disease Activity Scale). Furthermore, we will explore the potential of the
therapy in delaying the circadian entrainment (assessed by the melatonin onset
in saliva and sleep diary) and the mediating role of circadian entrainment
changes for therapy efficacy as well as the mediating role of depression in
reducing fatigue. Moreover, follow-up effects for primary and secondary therapy
efficacy outcomes and circadian entrainment outcomes will be explored.
Additionally, this pilot trial will assess therapy adherence, barriers to
adherence, therapy acceptability as well as study feasibility and study
acceptability. This will give insight into potential modifications that are
needed to the therapy and study. The last objective of this pilot trial is to
acquire relevant parameter estimates which are needed to design a possible
future full-scale RCT.
Study design
This is a randomized, double-blind, parallel-arm, placebo controlled (ratio
1:1), single center pilot trial consisting of an intervention group (active
BLT) and a control group (sham BLT). Outcomes will be assessed at baseline
(T0), at the end of the 4-week BLT (T1), and at follow-up (four weeks after
BLT; T2). The study will be reported according to the *Consolidated Standards
of Reporting Trials (CONSORT) 2010 statement: extension to randomised pilot and
feasibility trials* (Eldridge et al., 2016).
Intervention
In both arms, light therapy glasses (Luminette® (CE certified); Lucimed) will
be worn in the home of the participant every day for 30 minutes in the evening
(between 20:00-21:00 h) during four consecutive weeks. The two arms differ in
the wavelength of light that is emitted by the glasses (i.e. active bright
light vs. sham bright light).
Study burden and risks
At each measurement, participants fill in a questionnaire at home (± 25
minutes), they have to take ten saliva samples on a predefined evening and
night at home and they fill in a sleep diary at home for one (T0 and T2) or two
(T1) weeks (5 minutes / day). Participants will also visit the hospital at T0,
T1, and T2 for a physical examination and blood draw (i.e. DAS examination; ±
15 minutes); this is part of the standard treatment of patients with RA and
will therefore not impose any additional risks (only the frequency of
measurement is higher). All other measurements are considered minimally
invasive and pose little risk.
Patients are able to continue other light activities during the 30 minutes of
BLT. The therapy is expected to have no (long-lasting) negative effects. To
distinguish actual therapy effects from placebo effects, it is necessary to
include a control group receiving sham BLT.
This study may have a large impact for patients (as most important patients
centered outcomes could be improved by this therapy), health professionals,
researchers (e.g. rheumatologists and chronobiologists), and the society (e.g.
by reducing costs associated with fatigue and other outcome measures).
*
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
I. Patient is on stable disease-modifying antirheumatic drug (DMARD) therapy for at least 3 months before the start of the study.
II. Disease Activity Scale (DAS) 28 <= 3.2.
III. Patient has abnormal feelings of fatigue as assessed by Checklist Individual Strength (CIS)-8 >= 27 (indicates abnormal levels of fatigue) (Bultmann et al., 2000).
Exclusion criteria
I. Patient*s treatment consists of glucocorticoids, melatonin, or photosensitizing medication (e.g. amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, and/or temoporfin (Anderson et al., 2016)) and/or changed in type or dose within the last 3 months before start of the study.
II. Patient*s medical conditions or recent medical events potentially compromises the effects of safety of light therapy (e.g. psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, severe acute suicidality, history of light-induced migraine or epilepsy or severe side effects to light therapy in the past, and/or pre-existing ocular abnormalities (e.g. glaucoma, retinitis, retinopathy, and/or macular degeneration)).
III. Midsleep on free days corrected for sleep deficit build up during working days (as measured with the Munich Chronotype Questionnaire) > 4:00h which reflected patients with a late chronotype.
IV. Patient has been involved in light therapy within 1 year before the start of the study.
V. Patient has been unable to maintain a regular sleep schedule (e.g. due to shift work) within 1 year before start of the study and/or expected during the study.
VI. Patient has travelled within three months before study start and/or has the plan to travel during the study to a time zone that deviates two or more hours from the Netherlands; and
VII. Patient or partner is pregnant or has a wish for pregnancy during the therapy period or gives breastfeeding.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62780.058.17 |
| OMON | NL-OMON22327 |