Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461513
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2007-04-17
Brief Title:
Patient-Centered Heart Failure Trial
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Patient-Centered Disease Management for Heart Failure Trial
Status:
COMPLETED
Status Verified Date:
2018-06
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:
PCDM
Brief Summary:
The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure
Detailed Description:
BackgroundRationale Chronic heart failure CHF is a leading cause of morbidity and mortality in the VA Disease management is a promising strategy to improve care and outcomes but evidence supporting CHF disease management is inconsistent and open questions remain Prior studies have not evaluated a multi-modal intervention combining multidisciplinary collaborative care telemonitoring promotion of patient self-care and an explicit intervention for comorbid depression which is a barrier to optimal CHF care and outcomes Moreover the effectiveness of CHF disease management has not been evaluated in the VA
Objectives We propose to evaluate a Patient-Centered Disease Management PCDM intervention that includes case finding collaborative care management for both CHF and comorbid depression and home telemonitoring The primary aim will be to ascertain whether the PCDM intervention results in better patient health status ie symptom burden functional status and quality of life than usual care Secondary aims will include assessment of whether the intervention will reduce hospitalizations or mortality result in more guideline-concordant care and reduce depression while increasing patient medication adherence self-efficacy and satisfaction with treatment
Methods We propose a 3-year multi-site randomized study VA patients with CHF from 4 VA Medical Centers Denver Palo Alto Richmond and Seattle and their affiliated clinics who have diminished CHF-specific health status Kansas City Cardiomyopathy Questionnaire scores50 will be eligible We will randomize enrolled patients to a 12-month PCDM intervention versus usual care target 300 patients in each arm The PCDM intervention will include collaborative care management for CHF and comorbid depression and daily telemonitoring Patient self-care will be promoted through the telemonitoring intervention and the depression intervention The primary analysis will be a comparison of change in health status KCCQ scores between enrollment and 12 months for the intervention versus usual care groups Secondary analyses will include comparison of rates of hospitalization and death depressive symptoms the proportion of patients with guideline concordant CHF care medication adherence 6-minute walk test self-efficacy and patient satisfaction In addition cost-effectiveness analysis will be performed All analyses will be intention to treat
Impact If successful the proposed intervention will improve the quality of care and outcomes of veterans with CHF and be cost effective The intervention has the potential to serve as model for other disease management interventions in the VA and is designed as an effectiveness trial to enhance implementation This study will be a joint effort of the CHF and IHD QUERI groups Patient Care Services and Office of Care Coordination The study directly addresses several aims of the recently published QUERI A New Direction position statement including a partnership between QUERI groups b explicit collaborative ties between QUERI and operational components of the VA ie Patient Care Services and Office of Care Coordination c focus beyond a single disease entity ie CHF and depression and d clinical studies of interventions that might be candidates for national VA implementation Moreover this study specifically engages patients in their care and emphasizes quality of life outcomes both of central import to the VA health care mission
Objectives We propose to evaluate a Patient-Centered Disease Management PCDM intervention that includes case finding collaborative care management for both CHF and comorbid depression and home telemonitoring The primary aim will be to ascertain whether the PCDM intervention results in better patient health status ie symptom burden functional status and quality of life than usual care Secondary aims will include assessment of whether the intervention will reduce hospitalizations or mortality result in more guideline-concordant care and reduce depression while increasing patient medication adherence self-efficacy and satisfaction with treatment
Methods We propose a 3-year multi-site randomized study VA patients with CHF from 4 VA Medical Centers Denver Palo Alto Richmond and Seattle and their affiliated clinics who have diminished CHF-specific health status Kansas City Cardiomyopathy Questionnaire scores50 will be eligible We will randomize enrolled patients to a 12-month PCDM intervention versus usual care target 300 patients in each arm The PCDM intervention will include collaborative care management for CHF and comorbid depression and daily telemonitoring Patient self-care will be promoted through the telemonitoring intervention and the depression intervention The primary analysis will be a comparison of change in health status KCCQ scores between enrollment and 12 months for the intervention versus usual care groups Secondary analyses will include comparison of rates of hospitalization and death depressive symptoms the proportion of patients with guideline concordant CHF care medication adherence 6-minute walk test self-efficacy and patient satisfaction In addition cost-effectiveness analysis will be performed All analyses will be intention to treat
Impact If successful the proposed intervention will improve the quality of care and outcomes of veterans with CHF and be cost effective The intervention has the potential to serve as model for other disease management interventions in the VA and is designed as an effectiveness trial to enhance implementation This study will be a joint effort of the CHF and IHD QUERI groups Patient Care Services and Office of Care Coordination The study directly addresses several aims of the recently published QUERI A New Direction position statement including a partnership between QUERI groups b explicit collaborative ties between QUERI and operational components of the VA ie Patient Care Services and Office of Care Coordination c focus beyond a single disease entity ie CHF and depression and d clinical studies of interventions that might be candidates for national VA implementation Moreover this study specifically engages patients in their care and emphasizes quality of life outcomes both of central import to the VA health care mission
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