Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188357
Status:
UNKNOWN
Last Update Posted:
2007-02-14
First Post:
2005-09-09
Brief Title:
HIPP Learning to Live Better With Lupus The Health Improvement and Prevention Program in Systemic Lupus Erythematosus
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
HIPP Learning to Live Better With Lupus The Health Improvement and Prevention Program in Systemic Lupus Erythematosus
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
Several studies have shown that persons with systemic lupus erythematosus SLE have poor general health and a higher risk of heart attack and bone loss osteoporosis compared to the general population Some of the risks associated with heart attacks and bone loss are modifiable can be changed For example high blood pressure high cholesterol smoking lack of exercise are risk factors associated with heart attacks that can be changed Whereas age and a family history of heart attacks are risk factors that can not be changed Similarly a diet low in calcium smoking and lack of exercise are modifiable risk factors associated with osteoporosis while family history and age are not modifiable The Health Improvement and Prevention Program HIPP in Systemic Lupus Erythematosus was developed to increase the general health in persons who have lupus and to help reduce the risk of heart attacks and bone loss This intervention program gives comprehensive
information about lupus and provides tools on how to live better with lupus The program includes visits with a nurse case manager who will work in close collaboration with the lupus team She will work on an individual basis with each participant to develop a mutually agreed upon personalized care plan aimed at improving general health coping skills and heart and bone health
HIPP STUDY Health Improvement And Prevention Program
Dr Paul Fortin Principal Investigator
Primary and Secondary objectives
To improve health status decrease cardiovascular risk and improve endothelial function in persons with SLE compared to usual care
To improve bone health behaviors and prevent decrease in bone mineral density
To improve adherence to treatments
To help persons with Lupus move toward wellness by increasing knowledge
To show that HIPP is cost effective and could become standard care
Duration 2 years
Enrollment 240 patients
Study Design
Randomized prospective study of HIPP compared to usual care patients will be crossed over at Mth 12 Data collected for 24 mths
Demographic health status cost SLE knowledge coping cardiovascular and osteoporosis information will be collected
All patients will undergo clinical evaluation to measure disease activity BMD every 2 years and Flow mediated Doppler every year
HIPP now patients will attend 4 knowledge sessions covering SLE coping with chronic disease cardiovascular disease in Lupus bone health in Lupus
HIPP now patients will be followed by nurse coordinator and receive an individualized risk assessment telephone follow-up smoking cessation counseling For those found at risk stress reduction Mindfulness Based Stress Reduction and or bone health program will be provided Hipp now patients will attend Cardiac Rehabilitation Program at TWH All HIPP now pts will attend the Cardiac Rehabilitation program at the TWH
Inclusion Criteria
SLE according to ACR 18 yr Female must read and write french or english
Exclusion Criteria
MI TIA CVA Other arterial occlusion PVD Osteoporosis as defined by BMD Pregnant now active cancer
For further information contact Study Coordinator Anne Cymet Tel 13-2895 Pager 416-664-
information about lupus and provides tools on how to live better with lupus The program includes visits with a nurse case manager who will work in close collaboration with the lupus team She will work on an individual basis with each participant to develop a mutually agreed upon personalized care plan aimed at improving general health coping skills and heart and bone health
HIPP STUDY Health Improvement And Prevention Program
Dr Paul Fortin Principal Investigator
Primary and Secondary objectives
To improve health status decrease cardiovascular risk and improve endothelial function in persons with SLE compared to usual care
To improve bone health behaviors and prevent decrease in bone mineral density
To improve adherence to treatments
To help persons with Lupus move toward wellness by increasing knowledge
To show that HIPP is cost effective and could become standard care
Duration 2 years
Enrollment 240 patients
Study Design
Randomized prospective study of HIPP compared to usual care patients will be crossed over at Mth 12 Data collected for 24 mths
Demographic health status cost SLE knowledge coping cardiovascular and osteoporosis information will be collected
All patients will undergo clinical evaluation to measure disease activity BMD every 2 years and Flow mediated Doppler every year
HIPP now patients will attend 4 knowledge sessions covering SLE coping with chronic disease cardiovascular disease in Lupus bone health in Lupus
HIPP now patients will be followed by nurse coordinator and receive an individualized risk assessment telephone follow-up smoking cessation counseling For those found at risk stress reduction Mindfulness Based Stress Reduction and or bone health program will be provided Hipp now patients will attend Cardiac Rehabilitation Program at TWH All HIPP now pts will attend the Cardiac Rehabilitation program at the TWH
Inclusion Criteria
SLE according to ACR 18 yr Female must read and write french or english
Exclusion Criteria
MI TIA CVA Other arterial occlusion PVD Osteoporosis as defined by BMD Pregnant now active cancer
For further information contact Study Coordinator Anne Cymet Tel 13-2895 Pager 416-664-
Detailed Description:
The survival rate in Systemic Lupus Erythematosus SLE exceeds 90 at 10 years but health status is severely impaired and comparable with that of advanced cardiac or respiratory diseases Since these issues are often overlooked in clinical practice and because SLE affects primarily young women in their productive life a specific intervention is needed to heighten health status and coping and to reduce complications such as cardiovascular diseases CVD and osteoporosis
Our primary goal is to demonstrate 1- that a coordinated intervention named the Health Improvement and Prevention Program HIPP will improve health status in SLE compared with usual care and 2- that the same intervention will decrease significantly the number of cardiovascular risk factors and improve the flow-mediated dilatation FMD - a non-invasive measure of endothelial health that we will use as a surrogate marker of CVD in persons with SLE Our secondary goals are to demonstrate that HIPP will 1- improve bone health behaviors and prevent decrease in bone mineral density BMD 2- improve adherence to treatments 3- help persons with lupus move towards wellness on the illness-wellness continuum by increasing their knowledge of lupus and 4- be shown to be a cost-effective intervention that could become standard of care in SLE
Our population will consist of consecutive patients with a diagnosis of SLE revised 1997 ACR criteria from the lupus clinics of the University of Toronto and McGill University All those without cardiovascular disease or osteoporosis will be approached for this study These two centres follow annually a total of close to 700 persons with SLE and offer standard HIPP services
Our study design is a randomized prospective study of HIPP compared to usual care As we believe that HIPP will be superior to usual care we will crossover those in the usual care group to the HIPP group at 12 months We will collect information for 24 months on all participants The Health Improvement and Prevention Program is a multidisciplinary intervention that will be coordinated by a case manager nurse in close collaboration with the lupus treating team After providing consent each person will fill in demographic health status cost SLE knowledge coping cardiovascular and osteoporosis risk questionnaires and will undergo a clinical evaluation to measure lupus disease activity and damage as well as a FMD and BMD They will be randomized to HIPP or to usual care for 12 months after which the usual care group will be crossed over to HIPP HIPP participants will be invited to attend a 4-week 6 hour course that will cover the following four topics 1 Knowledge of SLE 2 Coping with a Chronic Disease 3 Cardiovascular Disease in SLE and 4 Bone Health in SLE Four to six weeks after entry into HIPP there will be a second visit to the case manager during which an individualized program will be proposed to the patient For all patients this will include a standardized CVD prevention program For those found to be at risk at baseline it will also include a stress-reduction andor a bone-health program The case manager will follow HIPP participants individually by phone or in person according to their needs Follow-up questionnaires on health status cost and coping will be done by phone at 6 and 18 months repeat clinical assessments for lupus activity and damage questionnaires and FMD will be done at 12 and 24 months and BMD will be repeated at 24 months
Power and analyses We will need to enroll 120 patients in our study to ensure 80 power to detect at least a 10 improvement in the SF-36 MCS and PCS and a 20 CVD risk reduction Descriptive analyses univariate and multivariate analyses will be carried out For our primary goals we will test whether HIPP is better than usual care in improving the SF-36 MCS PCS and CVD risk profile Our outcome will be change in the SF-36 MCS or PCS scores FMD or CVD risk assessment and our predictive variable will be HIPP We will adjust for age gender and baseline SF-36 MCS and PCS depression score education lupus activity and damage Other secondary outcomes will be analysed using similar models Cost will be calculated and cost-effectiveness analyses of HIPP will be performed
Significance A valid cost-effective and comprehensive program to ameliorate the health and coping status and to prevent CVD and osteoporosis would have a high impact on the long-term health and quality of life of persons with SLE
Our primary goal is to demonstrate 1- that a coordinated intervention named the Health Improvement and Prevention Program HIPP will improve health status in SLE compared with usual care and 2- that the same intervention will decrease significantly the number of cardiovascular risk factors and improve the flow-mediated dilatation FMD - a non-invasive measure of endothelial health that we will use as a surrogate marker of CVD in persons with SLE Our secondary goals are to demonstrate that HIPP will 1- improve bone health behaviors and prevent decrease in bone mineral density BMD 2- improve adherence to treatments 3- help persons with lupus move towards wellness on the illness-wellness continuum by increasing their knowledge of lupus and 4- be shown to be a cost-effective intervention that could become standard of care in SLE
Our population will consist of consecutive patients with a diagnosis of SLE revised 1997 ACR criteria from the lupus clinics of the University of Toronto and McGill University All those without cardiovascular disease or osteoporosis will be approached for this study These two centres follow annually a total of close to 700 persons with SLE and offer standard HIPP services
Our study design is a randomized prospective study of HIPP compared to usual care As we believe that HIPP will be superior to usual care we will crossover those in the usual care group to the HIPP group at 12 months We will collect information for 24 months on all participants The Health Improvement and Prevention Program is a multidisciplinary intervention that will be coordinated by a case manager nurse in close collaboration with the lupus treating team After providing consent each person will fill in demographic health status cost SLE knowledge coping cardiovascular and osteoporosis risk questionnaires and will undergo a clinical evaluation to measure lupus disease activity and damage as well as a FMD and BMD They will be randomized to HIPP or to usual care for 12 months after which the usual care group will be crossed over to HIPP HIPP participants will be invited to attend a 4-week 6 hour course that will cover the following four topics 1 Knowledge of SLE 2 Coping with a Chronic Disease 3 Cardiovascular Disease in SLE and 4 Bone Health in SLE Four to six weeks after entry into HIPP there will be a second visit to the case manager during which an individualized program will be proposed to the patient For all patients this will include a standardized CVD prevention program For those found to be at risk at baseline it will also include a stress-reduction andor a bone-health program The case manager will follow HIPP participants individually by phone or in person according to their needs Follow-up questionnaires on health status cost and coping will be done by phone at 6 and 18 months repeat clinical assessments for lupus activity and damage questionnaires and FMD will be done at 12 and 24 months and BMD will be repeated at 24 months
Power and analyses We will need to enroll 120 patients in our study to ensure 80 power to detect at least a 10 improvement in the SF-36 MCS and PCS and a 20 CVD risk reduction Descriptive analyses univariate and multivariate analyses will be carried out For our primary goals we will test whether HIPP is better than usual care in improving the SF-36 MCS PCS and CVD risk profile Our outcome will be change in the SF-36 MCS or PCS scores FMD or CVD risk assessment and our predictive variable will be HIPP We will adjust for age gender and baseline SF-36 MCS and PCS depression score education lupus activity and damage Other secondary outcomes will be analysed using similar models Cost will be calculated and cost-effectiveness analyses of HIPP will be performed
Significance A valid cost-effective and comprehensive program to ameliorate the health and coping status and to prevent CVD and osteoporosis would have a high impact on the long-term health and quality of life of persons with SLE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-0084 | None | None | None |