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van CCT (UK)

van CCT (UK)

Online self-management in hand osteoarthritis

- candidate number26524
- NTR NumberNTR6266
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jan-2017
- Secondary IDsNL55536.058.15 P15.379
- Public TitleOnline self-management in hand osteoarthritis
- Scientific TitleAn online self-management intervention for patients with hand osteoarthritis – an RCT’
- hypothesisObjectives: to study the effectiveness of the online self-management intervention in patients with hand OA and to explore the possibilities to implement the intervention in clinical practice after the study period.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, E-health, Selfmanagement
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria (these are all to be checked by the doctor/research nurse at the consultation):

- Diagnosed with hand OA, following American College of Rheumatology (ARC) criteria (Altman et al., 1990)
- Referred to the hand OA care path
- Complaints from hand OA including pain, with a minimal duration of 3 months
- Minimum age of 18 years
- Fluent in Dutch language
- Able to give informed consent
- Own a computer with internet access
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study (these are all to be checked by the doctor/research nurse at the consultation):

- Difficulties in (written) communication (e.g., due to analphabetism)
- Severe psychiatric comorbidities that interfere with the study protocol
- On-going psychological treatment elsewhere
- Patients with secondary OA due to diseases such as 1) inflammatory rheumatic diseases, as rheumatoid arthritis, psoriatic arthritis, etc, 2) bone diseases, as M. Paget, osteochondritis, 3) metabolic diseases associated with joint disease, as hemochromatosis, acromegaly, 4) severe crystal arthropathies, as topheus polyarticular gout.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-apr-2016
- planned closingdate
- Target number of participants70
- InterventionsAn RCT will be performed, in which 35 participants will be randomized to either care as usual (hand OA care path, including consultation with the rheumatologist and a 1,5 hour consultation with a clinical nurse or occupational therapist) and 35 participants to care as usual plus the online self-management intervention. The intervention is based on cognitive-behavioral methods. It starts off with a face-to-face introduction consultation. Subsequently, the tailored self-management intervention will be offered via an online program. The intervention consists of six modules containing pain education, practical assignments, relaxation training, and registrations. The first and last modules are an introductory and closure module; in between are four modules aimed at learning how to cope with the consequences of a chronic condition in daily life. The modules focus on (1) activity, (2) mood, (3) thoughts, and (4) the social environment. At least once a week, participants receive feedback on the assignments and motivational support from a psychologist, by means of text messages in a secured mail box in the online program. After finishing the online program, patients will be approached by their treating psychologist for two booster sessions via telephone. In these booster sessions it will be evaluated how the patient further attained his/her pre-set goals for the intervention. Strategies to strengthen the achieved results will be discussed. The booster sessions will take place 1 month and 2,5 months after finishing the online program.
- Primary outcomeThe primary endpoint is the difference in change from baseline on VAS pain coping between patients in the intervention and control condition after the intervention and at 6 weeks and 3 months follow-up.
- Secondary outcomeSecondary endpoints are the differences between patients in the intervention and control condition on several other psychological and physical outcome measures, measured at baseline, after the intervention and at 6 weeks and 3 months follow-up.

Endpoints, measured with validated questionnaires:
 hand pain and well-being by visual analogue scales
 physical and mental HR-QoL by the RAND SF-36 and EQ-5D-5L
 pain and disability by AUSCAN subscales
 pain interference in daily functioning and pain severity by the Multidimensional Pain Inventory (MPI)
 illness cognitions by the Illness Cognition Questionnaire (ICQ)
 coping strategies by the Pain Coping Inventory (PCI)
 illness perception by the Illness Perception Questionnaire (IPQ)

Also, cost-effectiveness of the intervention will be measured, by assessing productivity loss and health care use of participants (using iPCQ and iMCQ).
- TimepointsPrimary and secondary outcomes are measured at baseline, after 3 months, after 4,5 months (follow-up) and after 6 months (follow-up).
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Programma Zorgvernieuwing
- Publications
- Brief summaryHand osteoarthritis has a high clinical burden, as reflected by considerable pain, decreased strength and mobility, physical disability, and an often decreased health-related quality of life (HR-QoL). Self-management factors related to physical and psychosocial adjustment, such as patients’ perceptions about their disease and coping, play an important role in HR-QoL and functional ability in patients with chronic diseases, such as OA. Improving capacities of patients in managing a chronic condition is increasingly recognized as important in the treatment of (somatic) conditions and becomes more common in clinical practice and research. In this study, the effect of an online self-management intervention focusing on coping skills related to chronic pain in comparison to care as usual is studied.
- Main changes (audit trail)
- RECORD23-jan-2017 - 29-apr-2017

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