Dissemination of the Lupus Interactive Navigator

NCT02950714 | Completed

• 1 other identifier: KAL-356634
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 10

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Patient Activation Measure (PAM)

  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.

  Baseline, three and six months evaluations. Final evaluation at six months.

Secondary Outcomes (3)

• Lupus self-efficacy scale (LSES)

  Baseline, three and six months

• Coping with Health Injuries and Problems (CHIP)

  Baseline, three and six months

• Health status measured by the SF-36 version 1

  Baseline, three and six months.

Study Arms (2)

LIN_NOW

EXPERIMENTAL

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

LIN_WAIT

ACTIVE COMPARATOR

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.

Other: LIN_WAIT

Interventions

LIN_NOW OTHER

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.

LIN_NOW

LIN_WAIT OTHER

Usual care for three months prior to access to the LIN

Also known as: LIN at 3 months

LIN_WAIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (10)

Calgary Health Sciences Centre

Calgary, Alberta, Canada

Location

Edmonton University of Alberta

Edmonton, Alberta, T6g 2G3, Canada

Location

Vancouver Arthritis Research Centre

Vancouver, British Columbia, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

Hamilton McMaster University

Hamilton, Ontario, Canada

Location

London St. Joseph Health Sciences Centre London

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Centre de recherche du CHU de Québec - université de Laval

Québec, G1V 4G2, Canada

Location

Related Publications (1)

• Fortin PR, Neville C, Julien AS, Rahme E, Haroun V, Nimigon-Young J, Morrison AL, Eng D, Peschken CA, Vinet E, Hudson M, Smith D, Matsos M, Pope JE, Clarke AE, Keeling S, Avina-Zubieta JA, Rochon M, Da Costa D. Measuring the Impact of MyLupusGuide in Canada: Results of a Randomized Controlled Study. Arthritis Care Res (Hoboken). 2023 Mar;75(3):529-539. doi: 10.1002/acr.24871. Epub 2022 Nov 17.

  PMID: 35225436 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Paul R Fortin, MD,MPH,FRCPC

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 1, 2016
• Study Start: October 30, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)