Dissemination of the Lupus Interactive Navigator: Measuring Its Uptake and Impact on Global Health and Self-care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 541
- Locations
- 10
- Primary Endpoint
- Patient Activation Measure (PAM)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Two levels of entry criteria are to be considered: 1) at the centre level and 2) at the patient level.
- •Centre level:
- •to have a centre affiliation with the Canadian Network for improving outcomes in Systemic Lupus Erythematosus (CaNIOS) and a lupus clinical expert who is an active member of CaNIOS willing to sign the letter of invitation,
- •to have a list of patients with contact information (mailing or an electronic address)
- •to have research staff available to prepare and submit this study to the local research ethics board.
- •Patient level:
- •≥18 years of age
- •Diagnosis of Systemic Lupus Erythematosus (SLE) by the American College of Rheumatology (ACR) classification criteria, OR the new Systemic Lupus International Collaborating Clinics criteria (SLICC), OR deemed to have SLE by the treating physician
- •Able to read and write in English or French
- •Able to provide informed consent
- •Able to provide contact information (postal mail and email)
- •Able to complete online questionnaires.
Exclusion Criteria
- •Those that do not meet entry criteria.
Arms & Interventions
LIN_NOW
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.
Intervention: LIN_NOW (Other)
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.
Intervention: LIN_WAIT (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Coping with Health Injuries and Problems (CHIP)(Baseline, three and six months)
- Lupus self-efficacy scale (LSES)(Baseline, three and six months)
- Health status measured by the SF-36 version 1(Baseline, three and six months.)
Investigators
Paul Fortin
Professor of Medicine
CHU de Quebec-Universite Laval