We report the first randomized clinical trial of a Web-based patient self-management intervention integrated with an e-PHR for any neurological disease. We demonstrated that such a trial is feasible to construct, enroll patients, and implement. Using a novel randomized, automated recruitment system that included broad inclusion criteria and actively solicited participation, we recruited a sample of patients that is typical of the general MS clinical population and specifically representative of the patients at our MS center. Thus, we consider the study sample and findings to be generalizable to other MS clinic patients.12
The enrolled patients were predominantly female, white, and ~50 years old, with a mean educational level beyond high school. Measures of physical and cognitive abilities suggest that subjects were minimally to moderately impaired. The two groups were comparable on most pertinent variables.
Although the disease-specific system components and content make it difficult to compare our system utilization to that reported for other Web-based self-management programs, each component was utilized, with subjects (88%) from both groups using the messaging function and 64% (66/102) of the MCCO-enhanced group responding to prompts to complete scheduled self-monitoring. The retention rate (81%) from this 12-month intervention is comparable (79%) to that reported by Lorig et al.3
at 1 year after a 6-week Internet-based chronic disease intervention for patients with a variety of conditions and is greater than that for a large 5-year (n
985, retention rate: 52%) Internet-based intervention for diabetes management.4
These comparisons must be viewed cautiously, given the nature and duration of the interventions.
However, our hypotheses were not confirmed. We found no significant differences for the primary outcome measures. Several reasons may account for this lack of effect. First, the anticipated three-point change in SIP, which was the basis of our sample size calculation, did not occur. In fact, clinical change was minimal from baseline to study month 12 for the majority of outcome measures. Most MS clinical trials designed to test medications involve a study period of 2 years or more, whereas we looked for differences in endpoints over 12 months. Although we did not determine the number of participants with relapsing-remitting or primary progressive MS, a significant proportion of subjects were more likely in the relapsing-remitting stage of the disease. Given the slowly progressive nature of relapsing-remitting MS, this may account for a minimal change; if patients do not experience a change in symptoms, they may be less likely to use the system. Second, the number of individuals who did not complete the study was larger than estimated in the sample size calculation, thus influencing the power to detect differences. Finally, this intervention was patient-driven and designed to allow the participant to determine the amount of intervention. Although many features of the enhanced system were used, it is possible they were not utilized often enough to make a difference in outcomes. Since this study was initiated, several reports have suggested that there are barriers to patients with MS actively engaging in health promotion20
and self-care decision making.21
Additionally, several recent studies indicate interactive self-management interventions that involve clinical staff as active partners who engage participants in goal-setting, monitoring, and education produce better results22,23
; the Agency for Healthcare Research and Quality has suggested such an approach.24
As our system does not involve direct patient–clinician interaction, our findings support these studies. Although the utilization of the enhanced MCCO system suggests that these features may be useful components to include in future systems, perhaps a more active intervention that permits subjects to determine which aspects of self-management they want to address (e.g., fatigue management or increased exercise tolerance) and includes self-management support as described above would be more effective. Finally, the amount of intervention between the two groups may have been insufficient to produce between-group differences; in particular, this is suggested by the findings that only a minority of patients used the appointment preparation function and fewer than expected used the self-monitoring function.
This study has several limitations. This intervention was designed to assist patients with a wide variety of symptoms to improve self-management. More targeted, goal-directed interventions may have greater benefit. The duration of the intervention may have also limited its impact.
In conclusion, we found that individuals in both groups used the assigned components of our self-management system, but that the enhanced system did not lead to the expected improvements in patient- and clinician-reported outcomes. Nonetheless, this study demonstrates the feasibility of conducting practical trials using Internet-based systems that interface with e-PHRs. This trial serves as a possible model for using practical, controlled trials in comparative effectiveness research in neurological diseases.