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Dissemination of the Lupus Interactive Navigator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02950714
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : January 31, 2019
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Paul Fortin, CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Other: LIN_NOW Other: LIN_WAIT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: 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.
Other: LIN_NOW
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  1. 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,
  2. to have a list of patients with contact information (mailing or an electronic address)
  3. to have research staff available to prepare and submit this study to the local research ethics board.

Patient level:

  1. ≥18 years of age
  2. 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
  3. Able to read and write in English or French
  4. Able to provide informed consent
  5. Able to provide contact information (postal mail and email)
  6. Able to complete online questionnaires.

Exclusion Criteria: Those that do not meet entry criteria.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02950714

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Canada, Alberta
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
Canada, Manitoba
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
Canada, Ontario
Hamilton McMaster University
Hamilton, Ontario, Canada
London St. Joseph Health Sciences Centre London
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Canada, Quebec
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
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Paul R Fortin, MD,MPH,FRCPC CHU de Quebec-Universite Laval
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Responsible Party: Paul Fortin, Professor of Medicine, CHU de Quebec-Universite Laval Identifier: NCT02950714    
Other Study ID Numbers: KAL-356634
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases