|- candidate number||9414|
|- NTR Number||NTR2886|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-mei-2011|
|- Secondary IDs||P1133 / 2011/246; METC Slotervaart/Reade / METC VUmc|
|- Public Title||Integrated care intervention for workers with rheumatoid arthritis.|
|- Scientific Title||Integrated care intervention for workers with rheumatoid arthritis using an innovated system approach. A randomized controlled trial and process evaluation.|
|- ACRONYM||Care for Work|
|- hypothesis||We aim to improve work participation in workers with RA by our intervention program, which consists of integrated care and a participative workplace intervention.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||1. Patients diagnosed with RA;|
2. Aged 18-64 years;
3. Working at least 8 hours per week;
4. Attending a rheumatologist from Reade, the Reade outposts or the department of rheumatology of the VUmc.
|- Exclusion criteria||1. Severe comorbidity that will hamper compliance to the protocol;|
2. Unable to read or understand the Dutch language;
3. Taking over 3 months sick leave at the time of inclusion.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-mrt-2014|
|- Target number of participants||142|
|- Interventions||The intervention program consists of two components. The first component, integrated care, will be executed by a multidisciplinary team, consisting of an occupational therapist, the patients' own rheumatologist, and a clinical occupational physician who will act as care manager. The care manager facilitates and coordinates communication between the menbers of the multidisciplinary team. The second component is a participative workplace intervention. The occupational therapist will, together with the patient and the patients' supervisor, develop an action plan concerning adaptations at the workplace.
The control group will receive usual rheumatologist-led care only.
|- Primary outcome||The primary outcome of this study is hours lost from work due to presenteeism.|
|- Secondary outcome||1. Sick leave;|
2. Quality of life;
3. Patients' global assessment of pain and fatigue;
4. Work instability.
|- Timepoints||Measurements will take place at baseline, and after 6 and 12 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Ms. PhD. Cecile R.L. Boot|
|- CONTACT for SCIENTIFIC QUERIES||Ms. PhD. Cecile R.L. Boot|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute, Department of Public and Occupational Health|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, GAK Foundation, TNO|
|- Brief summary||Rationale: |
Work participation is lower in patients with rheumatoid arthritis (RA) compared to the general Dutch population. The health care patients with RA receive in the Netherlands is strictly separated in an occupational and a curative health system. For this reason, communication between caregivers is poor and often conflicting advises are given. Furthermore, work is not a standard topic during consultations with the rheumatologist, and the occupational physician is only involved if a patient is already on sick leave. There is a strong need for multidisciplinary recommendations for work activities in chronic diseases.
The primary objective of this study is to develop and evaluate an intervention program with the aim to improve work participation in patients with RA.
A multicenter single-blind randomized controlled trial to compare the intervention program including rheumatologist-led usual care with usual rheumatologist-led care only. Furthermore, a process evaluation will be conducted.
Workers with RA, aged 18-64 years, attending a rheumatologist who are involved in paid work for at least 8 hours per week.
The intervention program consists of two components. The first component, integrated care, will be executed by a multidisciplinary team. The multidisciplinary team consists of an occupational therapist, the patients' own rheumatologist, and a clinical occupational physician who will act as care manager. The care manager facilitates the communication between members of the multidisciplinary team. After consultation with the patient, the care manager proposes a treatment plan and informs the multidisciplinary team. The second component of the intervention program is a participative workplace intervention. The occupational therapist will, together with the patient and the patientsí supervisor, develop an action plan concerning adaptations at the workplace.
Main study parameters/endpoints:
The primary outcome of this study is hours lost from work due to presenteeism, measured by the Work Limitations Questionnaire (WLQ).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Measurements in this study will occur by means of questionnaires, which will take place at baseline, and after 6, and 12 months. The control group will receive usual care by their rheumatologist. Besides regular care by the rheumatologist, participants of the intervention group will have three consultations with the care manager. Furthermore, they will engage in the workplace intervention with their supervisor and an occupational therapist.
|- Main changes (audit trail)|
|- RECORD||5-mei-2011 - 29-mrt-2012|