|- candidate number||6698|
|- NTR Number||NTR2100|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-nov-2009|
|- Secondary IDs||170992803 ZonMw|
|- Public Title||Tailored cognitive-behavioral E-health care in patients with rheumatoid arthritis.|
|- Scientific Title||Tailored cognitive-behavioral E-health care in patients with rheumatoid arthritis.|
|- hypothesis||The aim of the study is to show the effectiveness of tailored cognitive-behavioral E-health care for risk groups of patients with rheumatoid arthritis in comparison to usual care.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||1. ACR diagnosis rheumatoid arthritis; |
2. Age above 18 years.
|- Exclusion criteria||1. Pregnancy; |
2. Severe physical and/or psychiatric comorbidity that interfere with the study procotol;
4. Current psychological treatments.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2009|
|- planned closingdate||1-jul-2012|
|- Target number of participants||130|
|- Interventions||The intervention of E-health tailored cognitive-behavioral therapy consists of tailored individual treatments with E-health treatment modules that target the most frequently experienced problems which rheumatoid arthritis patients have to cope with: pain and functional disability, fatigue, negative mood and social relationships. Choice of E-health treatment modules are determined on the basis of patient priorities and therapist judgments. All E-health treatments modules consist of cognitive and behavioral interventions with homework assignments of about half hour per day. In all treatments modules, the final booster session deal with relapse prevention and further improvement of the attained goals. For the E-health application, patients have at least once a week mail contact with the therapist.
Patients in the control group will receive standard rheumatology care without E-health or face-to-face applications of tailord cognitive-behavioral care.
|- Primary outcome||The primary outcome is the impact of the rheumatic disease on daily life, including its impact on physical and psychological functioning and daily activities at post-treatment and follow-up measurements after 9, 12, 15 and 18 months.
The primary outcome measures are measured as follows:
1. Impact on physical functioning: composite z-scores of
A. Pain (IRGL, Huiskes, 1990);
B. Fatigue (CIS, Vercoulen, 1996).
2. Impact on psychological functioning: composite z-scores of:
A. Negative mood (IRGL, Huiskes, 1990);
B. Anxiety (IRGL, Huiskes, 1990);
C. Depression (BDI, Beck, 1988).
3. Impact on daily activities: composite z-scores of
A. Mobility and self-care (IRGL, Huiskes, 1990);
B. Role limitations due to emotional and physical health problems (SF-36. Ware, 1993).
|- Secondary outcome||Secondary outcomes include cost-effectiveness analyses and effects on disease severity and treatment compliance with regard to standard rheumatological care.
|- Timepoints||For the treatment group, asssessments take place before and after treatment (ca. 6 months later) and at the follow-up measurements 9, 12, 15 and 18 months after pretreatment.
For the control group, assessments take place at 0, 6, 9, 12, 15 and 18 months.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. A.W.M. Evers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.W.M. Evers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||In the present project, the effects of tailored E-health cognitive-behavior care are studied for patients with rheumatoid arthritis. In a randomized, controlled trial, rheumatoid arthritis patients are screened for psychological risk profiles. Patients at risk will be randomized to E-health cognitive-behavioral treatment care or a control condition with care as usual (without E-health or face-to-face cognitive-behavioral E-health care). It is expected that the E-health cognitive-behavioral care will be effective for the impact of the disease on physical and psychological functioning and daily activities at post-treatment and follow-up assessments. Secondary outcomes include cost-effectiveness as well as effects on disease severity and treatment compliance.|
|- Main changes (audit trail)||13-Mar-2013: Timepoints have been changed - NM|
Due to variable duration of treatment length, follow- assessments were anchored on the post-treatment assessment instead of on the pre-treatment assessment for all participants: For the treatment group, assessments take place before and after treatment and at the follow-up measurements 3, 6, 9 and 12 months post treatment. For the control group, assessments take place at 0, 6, 9, 12, 15 and 18 months.
|- RECORD||9-nov-2009 - 5-aug-2013|