Ignite Creation Date:
2024-05-06 @ 3:57 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02416479
Status:
UNKNOWN
Last Update Posted:
2018-05-04
First Post:
2015-04-04
Brief Title:
SystemCHANGE An Intervention for Medication Change in Adult Kidney Transplant Patients
Sponsor:
Cynthia Russell
Organization:
University of Missouri Kansas City
Study Overview
Official Title:
SystemCHANGE An Intervention for Medication Adherence in Transplant Recipients
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
ACTIVE_NOT_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:
MAGIC
Brief Summary:
With kidney transplant KT recipients as our exemplar population our goal is to develop and test interventions that increase medication adherence MA in chronically ill adults Among adult KT recipients non-adherence to immunosuppressive medications MNA is the leading predictor of poor outcomes including rejection kidney loss and death An alarming one-third of KT patients experience MNA even though the problem is preventable Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients Using a randomized controlled trial design with an attention-control group this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients This intervention shows great promise for increasing MA with a large effect size of 14 in our pilot study Grounded in the socio-ecological model SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines involving supportive others in routines and using medication taking feedback through small patient-lead experiments to change and maintain behavior The Medication Event Monitoring System cap which contains microelectronics that record the date and time of the cap removal will be used to measure MA Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase Mediators and moderators of MA will be examined Health outcomes will be compared and a cost-effectiveness analysis will be conducted
Detailed Description:
SPECIFIC AIMS For adult kidney transplant KT patients the leading predictor of rejection kidney loss death and their attendant costs is immunosuppressive medications nonadherence MNA An alarming one-third of KT recipients experience this preventable problem According to meta-analysis predictors of MNA are nonwhite ethnicity poorer social support and poorer perceived health Patients most frequent barrier to adhering to immunosuppressive medication is forgetting 9 Even minor deviations from adherence have shown negative effects though the precise extent of poor outcomes stemming from nonadherence is not clear Traditionally intervention studies aimed at boosting adherence target cognition knowledge attitudes beliefs and behavioral skills However these have proven marginally effective for individuals with acute and chronic illnesses and ineffective for adult KT recipients In a sample of KT recipients we propose to test the innovative and successful SystemCHANGE intervention which is grounded in the socio-ecological model This approach is a paradigm shift in behavioral interventions because it seeks to redesign the system of the interpersonal environment and daily routines linked to health behavior rather than to alter individuals efforts to change their behavior Using a four-pronged patient-centered approach we will 1 assess individual systems including important others who shape medication taking how they influence medication taking and their proposals for improving medication adherence 2 implement the proposed individual systems solutions for improving adherence 3 track adherence data and 4 evaluate adherence data through small experiments In our pilot study this intervention yielded a large effect size of 14
This studys innovation lies in its use of a socio-ecological model known as SystemCHANGE which differs greatly from previous cognitive and behavioral skills-focused interventions for improving medication adherence This will be the first rigorous evaluation of SystemCHANGE with a diverse sample of KT recipients and long-term follow up This study presents a unique opportunity to evaluate moderators and mediators of adherence and has potential based upon pilot work to have immediate dose impact As such it could hold great promise as an intervention that translates very well into practice settings Our 6-month SystemCHANGE intervention also referred to as intervention seeks to enhance adherence to immunosuppressive medication among adult KT recipients who are non-adherent The study is a randomized controlled trial with an attention-control intervention also referred to as control to determine persistence of medication adherence behavior change and differences in adherence between the two groups during the 6-month maintenance phase
Primary Aim PA
PA To determine whether the intervention is more effective than control in increasing medication adherence in adult KT recipients at the completion of the intervention and maintenance phases
Hypothesis Adult KT recipients participating in the intervention will have higher immunosuppressive adherence rates than those participating in the control at the completion of intervention and maintenance phases
Secondary Aim Sec
SA To examine the patterns of medication adherence in adult KT recipients in both groups
Research question RQ When does the intervention become effective eg what dose is needed RQ What is the pattern of decay in adherence over time in both groups
Exploratory Aims EA
EA1 To determine whether the intervention is more effective than the control in decreasing poor health outcomes eg increasing creatinineBUN infection acutechronic rejection graft loss death hospitalizations length of hospital stay and healthcare appointments
Hypothesis At one year there will be differential levels of poor outcomes with the intervention demonstrating lower levels of poor outcomes than the control
EA2 To evaluate the role of potential mediators and moderators of medication adherence and health outcomes in adult KT recipients in the intervention and those in the control
Hypothesis Incorporating potential mediators and moderators of the intervention eg nonwhite ethnicity perceived social support perceived health status personal systems behavior will increase the medication adherence variance explained by the intervention
EA3 To determine if the intervention is cost-effective Hypothesis The cost-effectiveness ratio for the intervention will be less than for the control
Each year 356 KT recipients per 100 are non-adherent with their medications which is the primary cause of post-transplant morbidity Thus the need for effective interventions is compelling Decreasing transplant complications from MNA will reduce costs and make additional kidneys available to those waiting for transplants by reducing the number of KT recipients who must rejoin the organ list This project builds on our research teams previous adherence work including a SystemCHANGE intervention pilot study that addresses Healthy People 2020 initiatives of reducing chronic kidney disease complications disability death and costs by optimizing transplant medication adherence and increasing the number of patients who receive a transplant
This studys innovation lies in its use of a socio-ecological model known as SystemCHANGE which differs greatly from previous cognitive and behavioral skills-focused interventions for improving medication adherence This will be the first rigorous evaluation of SystemCHANGE with a diverse sample of KT recipients and long-term follow up This study presents a unique opportunity to evaluate moderators and mediators of adherence and has potential based upon pilot work to have immediate dose impact As such it could hold great promise as an intervention that translates very well into practice settings Our 6-month SystemCHANGE intervention also referred to as intervention seeks to enhance adherence to immunosuppressive medication among adult KT recipients who are non-adherent The study is a randomized controlled trial with an attention-control intervention also referred to as control to determine persistence of medication adherence behavior change and differences in adherence between the two groups during the 6-month maintenance phase
Primary Aim PA
PA To determine whether the intervention is more effective than control in increasing medication adherence in adult KT recipients at the completion of the intervention and maintenance phases
Hypothesis Adult KT recipients participating in the intervention will have higher immunosuppressive adherence rates than those participating in the control at the completion of intervention and maintenance phases
Secondary Aim Sec
SA To examine the patterns of medication adherence in adult KT recipients in both groups
Research question RQ When does the intervention become effective eg what dose is needed RQ What is the pattern of decay in adherence over time in both groups
Exploratory Aims EA
EA1 To determine whether the intervention is more effective than the control in decreasing poor health outcomes eg increasing creatinineBUN infection acutechronic rejection graft loss death hospitalizations length of hospital stay and healthcare appointments
Hypothesis At one year there will be differential levels of poor outcomes with the intervention demonstrating lower levels of poor outcomes than the control
EA2 To evaluate the role of potential mediators and moderators of medication adherence and health outcomes in adult KT recipients in the intervention and those in the control
Hypothesis Incorporating potential mediators and moderators of the intervention eg nonwhite ethnicity perceived social support perceived health status personal systems behavior will increase the medication adherence variance explained by the intervention
EA3 To determine if the intervention is cost-effective Hypothesis The cost-effectiveness ratio for the intervention will be less than for the control
Each year 356 KT recipients per 100 are non-adherent with their medications which is the primary cause of post-transplant morbidity Thus the need for effective interventions is compelling Decreasing transplant complications from MNA will reduce costs and make additional kidneys available to those waiting for transplants by reducing the number of KT recipients who must rejoin the organ list This project builds on our research teams previous adherence work including a SystemCHANGE intervention pilot study that addresses Healthy People 2020 initiatives of reducing chronic kidney disease complications disability death and costs by optimizing transplant medication adherence and increasing the number of patients who receive a transplant
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