Plain English Summary
Background and study aims
Rheumatoid arthritis (RA) is a long-term disease causing pain, swelling (inflammation) and stiffness in the joints. It is part of a group of diseases called autoimmune diseases, where the immune system starts to attack healthy joints. In healthy people, the body produces different types of immune cells. One of these is the B-cell, which produces antibodies to fight infection. In people with RA, these do not behave properly and produce antibodies which attack a person’s own body even if there is no infection. Early rheumatoid arthritis (ERA) is the name given to the first stages of the disease, when only the smaller joints, such as in the fingers and toes, are affected. By identifying and treating ERA early, it is possible to slow down the progression (worsening) of the disease. Telemonitoring is an emerging technique in which patients’ conditions are monitored away from the health care provider using electronic devices, which transmit the results to the health care provider. This allows doctors to keep track of a patient’s condition so that treatment can be delivered quickly and effectively. The aim of this study is to find out whether using a web-based monitoring system for patients with ERA is an effective way of controlling their condition.
Who can participate?
Adults suffering from early rheumatoid arthritis.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have five face-to-face sessions with their doctor at the start of the study and then at 3, 6, 9 and 12 months. These participants also take part in “televisits” (at 1, 2, 4, 5, 7, 8, 10 and 11 months), where they fill out a questionnaire online about any symptoms they are having, which is then sent to the doctor managing their case. This allows the case manager to monitor their condition from a distance. If any problems are flagged, then the case manager can call the participant and advice on how they might change their treatments to help lessen their symptoms and invite them to a clinic appointment if necessary. Those in the second group take part in the five face-to-face sessions with their doctor at the start of the study and then at 3, 6, 9 and 12 months only. In these sessions, their doctor is able to manage and change their treatment at their discretion. At the start of the study and again after one year, all participants complete a number of questionnaires in order to assess how bad their symptoms are and how well they are controlling their condition.
What are the possible benefits and risks of participating?
Participants in the telemonitoring group may benefit from being able to better manage their condition, as problems can be spotted earlier because of the continuous monitoring. There are no notable risks of taking part in the study.
Where is the study run from?
Rheumatic Disease Unit, Marche Polytechnic University (Italy)
When is the study starting and how long is it expected to run for?
June 2010 to June 2015
Who is funding the study?
Marche Polytechnic University (Italy)
Who is the main contact?
Professor Fausto Salaffi
Study website
Contact information
Type
Scientific
Contact name
Prof Fausto Salaffi
ORCID ID
http://orcid.org/0000-0002-3794-6831
Contact details
Clinica Reumatologica – Università Politecnica delle Marche
Via Aldo Moro
25
Jesi (Ancona)
60035
Italy
+39 (0)731534128
fausto.salaffi@gmail.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Observational study for the evaluation of safety and effectiveness of biologic drugs in patients with inflammatory rheumatic diseases based on a web platform
Acronym
Study hypothesis
To verify the effectiveness of a tight control strategy based on a a web platform in patients with inflammatory rheumatic diseases.
Ethics approval(s)
Comitato Unico Regionale – ASUR Marche, 20/04/2011
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Internet/virtual
Study type
Quality of life
Patient information sheet
Patient information is available in Italian at www.armonitor.net/telemonitoraggio/
Condition
Rheumatoid arthritis
Intervention
Participants are randomly allocated to one of two groups.
Group 1: Participants have their condition monitored using the intensive telemonitoring strategy, which involves five face-to-face visits (at baseline, 3, 6, 9 and 12 months) as well as eight televisits, which involve the patient filingl out the Recent-Onset Disability Index (ROAD) form on the website (1, 2, 4, 5, 7, 8, 10 and 11 months). The results of the televisits are sent to the physician case manager, allowing them to monitor the patient's response at distance and, if necessary, directly intervene by phoning the patient. During the phone call, patients were required to modify the treatment or were encouraged to return for a follow-up visit at the clinic for any treatment modification.
Group 2: Patients are monitored using the conventional approach. This involves being assessed by a rheumatologist at baseline, 3, 6, 9 and 12 months. In this group, treatment decisions were made at any visit according to the discretion of the rheumatologist, following the standard guidelines for treating rheumatoid arthritis.
Disease activity and disease control are measured for all participants at baseline and one year.
Intervention type
Other
Primary outcome measure
Disease activity, measured using the clinical disease activity index (CDAI) is measured at baseline and 1 year
Secondary outcome measures
Comprehensive disease control (CDC), measured using the clinical disease activity index (CDAI) and the Recent-Onset Disability Index (ROAD) at baseline and 1 year
Overall study start date
01/06/2010
Overall study end date
30/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of rheumatoid arthritis according the 2010 ACR/EULAR criteria for RA
2. Age 18 years and over
3. Disease duration less than 1 year (the disease duration was considered from the onset of the symptoms to baseline that corresponded with the point of diagnosis and with the start of treatment)
4. Clinical Disease Activity Index (CDAI) of 22 or over
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Two cohorts of 20 and 21 patients respectively
Participant exclusion criteria
1. Visual limitations were present
2. Hard of hearing and living alone
3. Poor command of the Italian language
4. Suffering from diseases requiring hospitalization such as chronic obstructive pulmonary disease, heart disease, multiple sclerosis, extracorporeal dialysis or chronic infectious disease
Recruitment start date
01/01/2012
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Italy
Study participating centre
Marche Polytechnic University
Rheumatic Disease Unit
Via Aldo Moro, 25
Jesi (Ancona)
60035
Italy
Sponsor information
Organisation
Università Politecnica delle Marche
Sponsor details
Piazza roma
22
Ancona
60121
Italy
+39 712202324
ricerca@univpm.it
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
University/education
Funder name
Università Politecnica delle Marche
Alternative name(s)
Polytechnic University of the Marche, UNIVPM
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Italy
Results and Publications
Publication and dissemination plan
Planned publciation in BMC Musculoskeletal Disorders.
Intention to publish date
30/06/2016
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/04/2016 | Yes | No |