Self-management interventions are essential to meet the challenges of improving the care of persons with lupus and must be built on sound person-centered approaches aimed at self-empowerment. As such, patients need to be equipped with technology to provide them with relevant information and support tools. The Lupus Interactive Navigator (LIN) was developed to target these needs in persons with lupus. The LIN is a web-based program designed to provide relevant information and support engagement and self-management in lupus. The LIN was tested on 43 patients with lupus and yielded very high ratings for relevancy, credibility, and usefulness of the information provided and is now ready for dissemination.
An unblinded randomized cross-over study of the impact of the LIN will be performed. The study population will be restricted to patients enrolled in lupus clinics affiliated with the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS). Centres will be randomized to be given access to the LIN at baseline (LIN_NOW) or be allocated to usual care with crossover to the LIN after a 3 month waiting period (LIN_WAIT) group. Following randomization, all participating CaNIOS centres will send a recruitment letter to all of their adult (18 years and older) lupus patients. The letter will explain that the nature of this national research project is aimed at measuring the usefulness of different support interventions in lupus.
Baseline: Patients willing to participate will be given instructions to access the survey website where they will be provided with consent and questionnaires to complete. following completion of the baseline questionnaires, patients in the LIN_NOW group will be given access to the LIN. Patients in the LIN_WAIT group will continue with usual care for three months.
Three months: Email reminders will be sent to all participants prior to the due date of the three month questionnaires. All email reminders will include the website link, instructions to access the user. The LIN-NOW group will continue with access to the LIN upon completion of these questionnaires. The LIN_WAIT group will continue with usual care for three months and cross over to the LIN upon completion of these questionnaires.
Six months: Email reminders will be sent to all participants to complete the third set of questionnaires prior to the due date.
Both NOW and WAIT groups will continue with access to the LIN upon completion of these questionnaires.
Measures: Questionnaires will include assessments of socio-demographic variables, patient activation, disease-related variables including self-reported disease activity and damage, coping, self-efficacy, mood and general health status. Four of the four main outcome measures relevant to this study will be, as follows:
The Patient Activation Measure PAM): The PAM is a 13-item that measures level of patient engagement in health care. This tool is designed to measure an individual's level of confidence, beliefs, knowledge, and skills about managing one's health. Respondents can answer with varying levels of agreement or disagreement on a 4-point Likert-type scale. This scale has been shown to have strong psychometric properties. The PAM has been used in observational and intervention studies as a patient-centered measure to monitor changes in patient's experiences over time, with higher scores related to greater self-management, healthy behaviors, medication adherence, better clinical outcomes and higher levels of satisfactions with services.
The Processes of Care Survey - Short Form (IPC-SF) assesses three domains of patient interpersonal centered care: communication, decision making, and interpersonal style. The following scales of the IPC-SF will be used: communication scales (lack of clarity, elicited concerns/responded, and explained results), patient-centered decision making scale, and one interpersonal style scale (compassionate/respectful). Higher scores indicate more reports of experiences of the specific dimension, such as more explanations or more instances of deciding together.
The Lupus Self-efficacy Scale (LSES) will measure patients' confidence related to lupus-specific domains. This 11-items version assesses level of confidence in managing or decreasing lupus-related symptoms (i.e. fatigue, mood). The construct and concurrent validity of this scale has been demonstrated . Self-efficacy has been found to be an important determinant in understanding the adoption of self-management approaches among patients with arthritis.
The Morisky Adherence Scale is a 4-item generic scale that may apply to all medications and diseases and does not measure any particular time frame.
Analysis. Descriptive statistics will be performed including a description of the use of LIN (number of visits, number of pages visited, number of minutes spent, etc). The first set of analyses will determine the impact of the LIN on the PAM, the primary outcome, for the entire population by comparing scores of both groups before and following a 3 month exposure to the LIN (differences in scores at 3 months versus baseline in LIN_NOW group pooled with the scores at 6 months versus 3 months in the LIN-WAIT group). Secondary analyses using the same predictor variable, the LIN, to determine the impact of the IPC-SF, LSES, and the Morisky scale, replacing the PAM as the outcome variable in those analyses. For each outcome variable, the analysis will compare mean differences in scores of the PAM at 3 months versus baseline. Multivariate analysis will control for demographic and clinical variables such as age, sex, education, access to internet, type of device use, disease duration, lupus activity, lupus damage, physical and mental health status, coping and social support. The second set of analyses will question whether there is a difference between exposure to the LIN and usual care by comparing the patients from the centres randomized to the use of the LIN in the first three months versus those from the centres randomized to usual care during that same period of time. The third sets of analyses will examine whether the impact that may be observed at three months in the group randomized to LIN now is sustained at six months by comparing the outcome measures at three and six months in the LIN_NOW group.
