Rheumatoid Arthritis Clinical Trial
Official title:
Tight Control of Disease Activity Among Patients With Rheumatoid Arthritis Based on a Systematic Telemedicine Treatment Strategy
The study aims to investigate the effect a systematic telemedicine intervention, based on
the tigth control principals, as a platform for disease monitoring among patients with
rheumatoid arthritis.
It is hypothesized that:
- A systematic telemedicine intervention targeted to tight control of disease activity
among patients with RA will be equally effective as usual care (outpatient consultation
by a rheumatologist).
- There will be no difference in the effect whether this telemedicine consultation is
carried out by a rheumatologist or a rheumatology nurse.
- Patient satisfaction and the patient's general perception of involvement in their
treatment will be increased for patients who receive the telemedicine intervention.
- All the effects will apply both in the short term (< 6 months) and in the long term (>
1 year).
Rheumatoid arthritis (RA) is a chronic disease affecting 0.5-1.0 % of the Danish population.
Due to an expected growing population and a higher proportion of elderly the prevalence is
likely to increase in the years to come.
Untreated RA will lead to joint destruction disabling the patients, but in recent years both
treatment and treatment strategies have been markedly improved. According to international
guidelines early start of medical treatment, quick escalation of doses, and adjustment of
the dose throughout the whole disease course when there are signs of disease activity, are
considered important elements in the RA treatment strategy. Consequently, the success of
this strategy implies the possibility of regular routine testing of all RA patients, which
could become a challenge to the health care system causing substandard treatment to RA
patients in the future. This calls for reorganization of the routine care of RA, i.e. in
form of a telemedicine intervention.
Telemedicine is considered to be the use of communication and information technologies to
deliver clinical care where the individuals involved are not at the same location. No
studies have yet investigated the effect of monitoring disease activity through a
standardized telemedicine treatment strategy in patients with RA, and most of the evidence
is derived from studies within chronic heart disease, chronic obstructive lung disease,
asthma, diabetes and hypertension. This evidence indicates, however, that telemedicine
interventions seem to be effective, time saving and associated with a high degree of patient
satisfaction.
RA disease activity is measured using a composite score that includes both objective and
subjective outcome parameters to measure present as well as past disease activity. These
scores include: tender and swollen joint count together with the patient's global
assessment, report of physical functioning, the measurement of an acute-phase reactant and
serial radiographic assessment. The most commonly used instruments for measuring RA disease
activity in daily clinical practice is the European League Against Rheumatism (EULAR)
criteria, the Disease Activity Score 28 (DAS28).
However, in a telemedicine intervention there is no direct physical contact between the
patient and the health professionals, making traditional disease activity measures unfit for
use, as they imply an assessment of tender and swollen joints carried out by a health
professional. It has been suggested to let the patients examine their joints. Still, it has
been shown that patients tend to overestimate the presence of swollen joints which impairs
the identification of synovitis - and thereby disease activity and flare. Hence,
telemedicine disease activity monitoring in RA may be best supported by validated measures
based on other kinds of patient self-assessment, i.e. the newly developed "Flare"
instrument.
According to international recommendations from the European League Against Rheumatism
(EULAR) patients should have access to nurse-led telephone services to enhance continuity of
care and to provide ongoing support, but it still remains unclarified which of the
occupational groups, doctors or nurses, is to carry out the routine telemedicine disease
monitoring.
The trend in RA treatment is towards patients taking a more active role in the treatment,
and telemedicine could be a very workable solution. However, before decision is made of
transforming tight control of disease activity among patients with RA into a telemedicine
intervention the effectiveness of such intervention, both when executed by doctors and
nurses, need to be investigated.
The objectives of this study are:
1. To test the effectiveness of a customized telemedicine intervention targeted to tight
control of disease activity among patients with RA, compared with usual outpatient care
in a pragmatic randomized controlled trail.
2. To test if the effect differs depending on whether the telemedicine consultation is
carried out by a rheumatologist or by a rheumatology nurse.
3. To examine the patients perspective towards telemedicine tight control of disease
activity in RA, and assess patient satisfaction and acceptability towards the
intervention.
Power calculation
A decrease in DAS28 on 1.2 is regarded as a significant clinically improvement. A change in
DAS28 on 0.6 is regarded as non-response . Thus, a change in the DAS28 score >0.6 will be
used as the cut-point for a change in the condition. The standard deviation in DAS28 is
presumed to be 1.5. Hence, in order to detect a 1-sided statistically significant change
between the three groups, with a statistical power on 80% (beta=0.20), a sample size of at
least 98 patients in each group is required.
Intervention
A systematic review of the literature has been conducted in order to make sure that the
telemedicine management is informed by evidence. Further, focus group interviews have been
conducted both among patient groups and among health professionals, to ensure that the
intervention is based on expert consensus.
The software used in the telemedicine intervention will be based on the established generic
Patient Reported Outcome (PRO) system, WestChronic, which was developed in 2004 for
collection of PRO data for research purposes in clinical epidemiological studies.
WestChronic supports dynamic dual mode data collection with web or paper forms as well as
communication to the patient with personalized postal letters, e-mails, and text messages.
All information regarding implementations, items and questionnaires, communication, users,
and patients resides in tables in a Structured Query Language (SQL) database, and all
administration of implementations, questionnaires, users, and patients is supported by the
server software and carried out in browser-windows. The software interphase serves a dual
purpose: a) to be a customized communication tool between the patients and the health
professionals, and b) to serve as decision support for the health professionals through the
incorporation of a validated disease self-assessment tool.
Decision support, the Flare instrument
The Flare instrument (FI) serves as decision support for assessing disease activity in RA
during the telemedicine intervention.
FI is a 12-item questionnaire where patients are asked to express their degree of agreement
about different statements concerning disease activity on a 10-point likert scale. Six items
concerns joint symptoms (tenderness, stiffness and pain) and six items is concerning general
symptoms. When scoring FI it is possible to compute a FI total score (all 12 items) or a
subscale for joint or general symptoms, respectively.
The instrument is translated into Danish according to the International Quality of Life
Asessment (IQULA) method. It is validated in a cross sectional study among 100 consecutive
patients from the outpatient clinic at Department of Rheumatology, Aarhus University
Hospital, using DAS28 as the gold standard (unpublished data).
Execution
After randomization patients will be allocated to one of the three treatment arms:
Telemedicine, doctor (TD), Telemedicine, Nurse (TN) or control in week 0, 13, 26, 39 and 52.
The telemedicine consultation will be based on a telephone consultation. The consultation
will follow a predefined consultation checklist.
Patients allocated to TD or TN, who has expressed a desire to complete questionnaires in
webform, will receive a letter a week before the consultation to remind them that they must
assess their disease activity through the software interphase, within the next couple of
days. Patients, who have expressed a wish to fill in questionnaires in paper form, will
receive the questionnaire a week before the consultation and asked to return it to
WestChronic immediately after completion. A chasing procedure will be carried out in case of
non-respondence. Two reminders will be send to the patients over a period of four weeks and
continuous non-respondence will hereafter lead to exclusion from the study.
During telephone consultation, updated clinical test results will be available through the
electronic medical system. Acute consultations will be performed and registered in all three
groups as needed.
Statistics
Comparisons between groups will be made with the Fisher exact test for dichotomous responses
and the Mann-Whitney U test for non-dichotomous responses. Changes over time will be
analyzed with McNemar's test for dichotomous responses and Wilcoxon signed rank sum test for
non-dichotomous responses. Data will be reported as a mean (SD) for variables in which
normal distribution is found; otherwise data will be reported as the median ((interquartile
range (IQR)).
Data will be analyzed using both "intention to treat" and per protocol. In case of missing
data multiple imputations will be used.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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