Background Web-based self-management enhancing programs have the potential to support patients with rheumatoid arthritis (RA) in their self-management; for example, improve their health status by increasing their self-efficacy or taking their prescribed medication. We developed a Web-based self-management enhancing program in collaboration with RA patients and professionals as co-designers on the basis of the intervention mapping framework. Although self-management programs are complex interventions, it is informative to perform an explorative randomized controlled trial (RCT) before embarking on a larger trial. Objective This study aimed to evaluate the efficacy of a Web-based self-management enhancing program for patients with RA and identify outcome measures most likely to capture potential benefits. Methods A multicenter exploratory RCT was performed with an intervention group and a control group. Both groups received care as usual. In addition, the intervention group received 12 months of access to a Web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included self-management behavior (Patient Activation Measurement, Self-Management Ability Scale), self-efficacy (Rheumatoid Arthritis task-specific Self-Efficacy, Perceived Efficacy in Patient-Physician Interaction), general health status (RAND-36), focus on fatigue (Modified Pain Coping Inventory for Fatigue), and perceived pain and fatigue (Numeric Rating Scales). A linear mixed model for repeated measures, using the intention-to-treat principle, was applied to study differences between the patients in the intervention (n=78) and control (n=79) groups. A sensitivity analysis was performed in the intervention group to study the influence of patients with high (N=30) and low (N=40) use of the intervention. Results No positive effects were found regarding the outcome measurements. Effect sizes were low. Conclusions Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcome measures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performed to provide more insight into the low compliance with and effectiveness of the intervention. This can determine for whom this sort of program will work and help to fine-tune the inclusion criteria. Trial Registration Netherlands Trial Register NTR4871; https://www.trialregister.nl/trial/4726

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BackgroundEvery day rheumatoid arthritis (RA) patients make many decisions about managing their disease. An online, computer-tailored, self-management program can support this decision making, but development of such a program requires the active participation of patients.ObjectiveTo develop an online, computer-tailored, self-management program integrated with the nursing care, as nurses have an important role in supporting self-management behavior.MethodsThe intervention mapping framework was used to develop the program. Development was a multistep process: (1) needs assessment; (2) developing program and change objectives in a matrix; (3) selecting theory-based intervention methods and practical application strategies; (4) producing program components; (5) planning and adoption, implementation, and sustainability; and (6) planning for evaluation.ResultsAfter conducting the needs assessment (step 1), nine health-related problems were identified: (1) balancing rest and activity, (2) setting boundaries, (3) asking for help and support, (4) use of medicines, (5) communicating with health professionals, (6) use of assistive devices, (7) performing physical exercises, (8) coping with worries, and (9) coping with RA. After defining performance and change objectives (step 2), we identified a number of methods which could be used to achieve them (step 3), such as provision of general information about health-related behavior, self-monitoring of behavior, persuasive communication, modeling, and self-persuasion and tailoring. We described and operationalized these methods in texts, videos, exercises, and a medication intake schedule. The resulting program (step 4) consisted of an introduction module and nine modules dealing with health-related problems. The content of these modules is tailored to the user’s self-efficacy, and patients can use the online program as often as they want, working through a module or modules at their own speed. After implementation (step 5), the program will be evaluated in a two-center pilot trial involving 200 RA patients. Log-in data and qualitative interviews will used for a process evaluation.ConclusionsThe intervention mapping framework was used to guide development of an online computer-tailored self-management program via a process which could serve as a model for the development of other interventions. A pilot randomized controlled trial (RCT) will provide insight into the important outcome measures in preparation for a larger RCT. The process evaluation will provide insight into how RA patients use the program and the attrition rate.Trial RegistrationNetherlands Trial Register (NTR): NTR4871; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4871 [accessed 13-NOV-15] http://www.webcitation.org/6d1ZyIoEy

BackgroundThe Allen Carr training (ACt) is a popular one-session smoking cessation group training that is provided by licensed organizations that have the permission to use the Allen Carr method. However, few data are available on the effectiveness of the training.MethodsIn a quasi-experimental design the effects of the existing practice of providing the ACt to smokers (n = 124) in companies on abstinence, were compared to changes in abstinence in a cohort of similar smokers in the general population (n = 161). To increase comparability of the smokers in both conditions, smokers in the control condition were matched on the group level on baseline characteristics (fourteen variables) to the smokers in the ACt. The main outcome measure was self-reported continuous abstinence after 13 months, which was validated using a CO measurement in the Act condition.ResultsLogistic regression analyses showed that when baseline characteristics were comparable, significantly more responding smokers were continuously abstinent in the ACt condition compared to the control condition, Exp(B) = 6.52 (41.1% and 9.6%, respectively). The all-cases analysis was also significant, Exp(B) = 5.09 (31.5% and 8.3%, respectively).ConclusionSmokers following the ACt in their company were about 6 times more likely to be abstinent, assessed after 13 months, compared to similar smokers in the general population. Although smokers in both conditions did not differ significantly on 14 variables that might be related to cessation success, the quasi-experimental design allows no definite conclusion about the effectiveness of the ACt. Still, these data support the provision of the ACt in companies.