Ignite Creation Date:
2024-05-06 @ 9:18 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02950714
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2016-10-19
Brief Title:
Dissemination of the Lupus Interactive Navigator
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Dissemination of the Lupus Interactive Navigator Measuring Its Uptake and Impact on Global Health and Self-care
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12000 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
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 12000 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
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 individuals level of confidence beliefs knowledge and skills about managing ones 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 patients 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 concernsresponded and explained results patient-centered decision making scale and one interpersonal style scale compassionaterespectful 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 ie 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
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 individuals level of confidence beliefs knowledge and skills about managing ones 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 patients 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 concernsresponded and explained results patient-centered decision making scale and one interpersonal style scale compassionaterespectful 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None