Dissemination of the Lupus Interactive Navigator
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|ClinicalTrials.gov Identifier: NCT02950714|
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : January 31, 2019
This study asks whether persons with lupus will use and uptake the information and services of the web-based lupus interactive navigator (LIN) on a regular basis and whether this uptake will be associated with better self-management, improved coping, higher sense of control over their life, and overall improved health.
Systemic lupus erythematosus is an incurable chronic multi-organ inflammatory disease that affects preferentially young women. Unmet needs include a 15% excess in mortality, high morbidity and poor work outcomes. Despite prevalence of 1:2000, lupus is mostly unknown from the public and access to specialized care remains limited. Therefore, persons with lupus and their caregivers have difficulty finding high quality information relevant to their "lupus journey".
The LIN research team consists of a lupus clinical expert and researcher, a clinical psychologist and behavioral researcher, and a health information specialist. This team, funded by the Canadian Institutes of Health Research (CIHR), was responsible for the development of the LIN, a web-based navigator designed to promote self-care. The LIN is completed and the team will work with several stakeholders for dissemination: Lupus Canada, the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS), the Arthritis Alliance of Canada, and lupus patient advisers. CaNIOS centres will be to randomized to immediate access to the LIN (LIN_NOW group) or usual care with crossover at 3 months (LIN_WAIT group). At baseline, all patients meeting entry criteria will be contacted, and asked to complete online questionnaires. At three months, a second online assessment will be performed before crossing over those from the centres randomized to usual care in order to now provide them with an access to the LIN. A final assessment will be performed at six months. Comparisons of baseline versus LIN exposure over three months will be performed in all patients at the end of the study; comparison of LIN use versus usual care will be done at three months; and retention of use at six months after LIN exposure will be documented in the first group randomized to LIN. The main outcome will be the Patient Activation Measure, a valid tool that measures the level of patient engagement. Secondary outcomes will include variables describing access and use of the LIN captured by the LIN server, coping, self-efficacy, and global health status.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Other: LIN_NOW Other: LIN_WAIT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||541 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dissemination of the Lupus Interactive Navigator: Measuring Its Uptake and Impact on Global Health and Self-care|
|Actual Study Start Date :||October 30, 2017|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
Participants from CaNIOS centres randomized to the NOW group will be provided immediate access to the lupus interactive navigator (LIN), a web-based program developed to promote engagement and self-care in lupus.
The Lupus interactive navigator (LIN) was developed to facilitate and support engagement and self-management for persons with lupus. It is a web-based program that provides access to relevant information, resources, support, and other tools to help them manage their illness. It is accessible by the Internet and compatible for use with computer, tablet, and mobile device. The content for the LIN was based on the results of focus group discussions and web-based surveys of persons with lupus and health care providers. Medical researchers, writers, designers and programmers worked with clinical experts affiliated with the Canadian Network for improved outcomes in Systemic Lupus Erythematosus (CaNIOS) and persons with lupus to provide the written content and interview videos.
Active Comparator: LIN_WAIT
Participants from CaNIOS centres randomized to the WAIT group will have usual care for three months prior to crossing over to access to the LIN.
Usual care for three months prior to access to the LIN
Other Name: LIN at 3 months
- Patient Activation Measure (PAM) [ Time Frame: Baseline, three and six months evaluations. Final evaluation at six months. ]The widely used 13-item PAM measures level of patient engagement in their healthcare [Development and testing of a short form of the patient activation measure. The 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 interventional 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. Between and within group changes in PAM scores over time of LIN exposure will be compared.
- Lupus self-efficacy scale (LSES) [ Time Frame: Baseline, three and six months ]The LSES adapted for lupus from the Arthritis Self-efficacy Scales 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. Between and within group changes in LSES scores over LIN exposure will be compared.
- Coping with Health Injuries and Problems (CHIP) [ Time Frame: Baseline, three and six months ]This 32-item questionnaire assesses coping strategies typically used when coping with health problems. Its four sub-scales include distraction, palliative, instrumental coping, and emotional coping. This instrument has been shown to have good psychometric properties and has been recommended for use with different medical populations. Between and within group changes in CHIP scores over LIN exposure will be compared.
- Health status measured by the SF-36 version 1 [ Time Frame: Baseline, three and six months. ]This generic measure has been recommended for use in lupus, as it is both valid and reliable. It consists of a self-administered instrument with 36 questions that cover eight dimensions of well-being: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Besides scoring for each of the eight domains, an algorithm also allows calculation of normalized scores for physical and mental function, the physical component score (PCS) and the mental component score (MCS). Between and within group changes in SF-36 version 1 scores over LIN exposure will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950714
|Calgary Health Sciences Centre|
|Calgary, Alberta, Canada|
|Edmonton University of Alberta|
|Edmonton, Alberta, Canada, T6g 2G3|
|Canada, British Columbia|
|Vancouver Arthritis Research Centre|
|Vancouver, British Columbia, Canada|
|Winnipeg Health Sciences Centre|
|Winnipeg, Manitoba, Canada|
|Hamilton McMaster University|
|Hamilton, Ontario, Canada|
|London St. Joseph Health Sciences Centre London|
|London, Ontario, Canada|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada|
|Jewish General Hospital|
|Montréal, Quebec, Canada|
|McGill University Health Centre|
|Montréal, Quebec, Canada|
|Centre de recherche du CHU de Québec - université de Laval|
|Québec, Canada, G1V 4G2|
|Principal Investigator:||Paul R Fortin, MD,MPH,FRCPC||CHU de Quebec-Universite Laval|