|- candidate number||6797|
|- NTR Number||NTR2137|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-dec-2009|
|- Secondary IDs||NL29524.091.09 CCMO|
|- Public Title||Non-pharmacological treatment in generalized osteoarthritis.|
|- Scientific Title||A randomized superiority trial investigating non-pharmacological care for patients with generalized osteoarthritis.|
|- ACRONYM||MEGA-study: the Maartenskliniek Evaluation of Generalized osteoArthritis study|
|- hypothesis||We hypothesize that a multidisciplinary group-based, self-management intervention is more effective on functioning in daily living and more cost-efficient than the active control group in patients with generalized osteoarthritis (GOA).|
|- Healt Condition(s) or Problem(s) studied||Generalized osteoarthritis|
|- Inclusion criteria||Men and women are eligible to enter the trial if they are: |
1. 18 years or older;
2. Diagnosed with GOA;
3. Properly motivated for changing lifestyle;
4. Willing to participate in a group;
5. Able to comply on the planned time schedule of both treatment conditions.
|- Exclusion criteria||Patients are excluded when they: |
1. Are awaiting surgery;
2. Already participated, unsuccessfully, in a self-management program;
3. Are suspected of high levels of distress;
4. Are illiterate;
5. Are not capable of communicating in Dutch;
6. Can't come to the hospital.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-sep-2012|
|- Target number of participants||160|
|- Interventions||Experimental intervention:|
The intervention lasts 6 weeks (max 8 persons per group), consists of 7 meetings, and aims improve the patients health related quality of life by optimising the current lifestyle (i.e. physical activity and diet) and by enhancing the self-efficacy to control the disease (i.e. activity pacing, pain management and daily functioning). To enhance the patientsí self-efficacy we use the 5As model of behaviour change counselling, which is an evidence-based approach appropriate for a broad range of different behaviours and health conditions. The 5As are as follows: Assessing patient level of behaviour, beliefs and motivation; Advising the patient based upon personal health risks; Agreeing with the patient on a realistic set of goals; Assisting to anticipate barriers and develop a specific action plan; and Arranging follow-up support. An example, a participant wears a pedometer to elicit his/her physical activity level (A1). Together with the health care provider, the patient discusses the outcome (A2) and set a goal to increase the level of physical activity (A3). Both the health care provider and the patient must believe the goal is good (A3) and feasible (A4). Consequently, patient and therapist closely monitor the personal goals (A5). Adjacent to the self-management programme, patients are also enrolled in an exercise programme aimed to 1. improve the quality of movement and 2. implement the learned exercises in the home situation.
Patients enrolled in the telephone counselling group, attend two group sessions and are further monitored through telephone contact and self-monitoring. As per with the experimental intervention, the active control intervention aims to optimise the patientsí current lifestyle (i.e. physical activity and diet) and to enhance the patientsí self-efficacy to control the disease (i.e. activity pacing, pain management and daily functioning). Again, all patients set a personal goals. Progress on these personal goals will be monitored by the health care provider through planned telephone contact. Patients are asked to self-monitor their own health-status, by filling out activity and eating diaries and wearing pedometers.
|- Primary outcome||Daily functioning: Health Assessment Questionnaire (HAQ);|
Minimal Important Change: 0.26;
Time points: first year after treatment.
1. Specific functioning: Patient specific complaints questionnaire (PSK);
2. Quality of life: RAND-36;
3. Fatigue: Checklist Individual Strength (CIS).
Time points for all abovementioned variables are: 6 weeks, 6 months, 1 year after baseline.
|- Secondary outcome||Costs: Questionnaire and diary.|
Time points for all abovementioned variables are: 6 weeks, 3 months, 6 months, 9 months, 1 year after baseline.
|- Timepoints||Time points are: 6 weeks, 3, 6,9 and 12 months, 1 year after baseline and the average over 1 year after baseline.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Thomas Hoogeboom|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.H.M. Ende, van den|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|Sint Maartenskliniek Nijmegen|
|- Brief summary||Rationale: An abundance of research literature illustrates that non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis (OA). To our knowledge however, only one study investigated the effect of NPT in the management of generalized osteoarthritis (GOA). This lack of research is a severe hiatus in current OA evidence. GOA-patients represent a substantial group of patients; it is estimated that 27% of patients with hip or knee OA also have GOA. Furthermore, the clinical picture of GOA is more complex than OA in a singular joint. Considering the latter, a comprehensive treatment programme focussing on the consequences of GOA on several aspects of health-related quality of life is warranted in this group of patients. In the literature several modes of delivery are proposed in the management of chronic diseases like arthritis.
|- Main changes (audit trail)|
|- RECORD||9-dec-2009 - 14-jan-2010|