Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444301
Status:
COMPLETED
Last Update Posted:
2008-06-11
First Post:
2007-03-05
Brief Title:
Pain Assessment Incidence Nature in Heart Failure
Sponsor:
PC-HEART
Organization:
PC-HEART
Study Overview
Official Title:
Investigating Pain in Heart Failure Patients
Status:
COMPLETED
Status Verified Date:
2008-06
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:
PAIN-HF
Brief Summary:
Heart failure a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue yet at least half of persons with heart failure also report the presence of pain
The cause of pain for these persons is not clear PAIN-HF Pain Assessment Incidence Nature in Heart Failure conducted through the Palliative Care-Heart Failure Education And Research Trials PC-HEART collaborative will identify the prevalence of pain its location severity and impact on activities and the possible causes of pain in persons living with heart failure The study will also try to understand relationships between other problems and pain as well as what treatments are given to reduce pain
Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure
The cause of pain for these persons is not clear PAIN-HF Pain Assessment Incidence Nature in Heart Failure conducted through the Palliative Care-Heart Failure Education And Research Trials PC-HEART collaborative will identify the prevalence of pain its location severity and impact on activities and the possible causes of pain in persons living with heart failure The study will also try to understand relationships between other problems and pain as well as what treatments are given to reduce pain
Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure
Detailed Description:
Subjects will be recruited via physicians and nurses providing their care in clinical sites who are members of PC-HEART PC-HEART is a volunteer collaborative with clinician-investigators at 60 sites nationally that include hospice organizations and heart failure providers in academic Health Maintenance Organization HMO and community settings Our goal will be to enroll 400 patients with 135 in hospice care and 265 in outpatient settings a mix of HMO community practice VA and academic centers who are members of the Palliative Care- Heart Failure Education And Research Trials PC-HEART collaborative We will strive for broad representation of patients living in the community with about one-third African American patients who often present for initial treatment with advanced heart failure and at least one-half elderly who have high prevalence of both pain and heart failure
We will use standardized tools to survey patients as follows
Pain other symptoms Assessed at enrollment and one-two weeks later
Memorial Symptom Assessment Scale- HF MSAS-HF Short-form McGill pain questionnaire SF-MPQ Brief Pain Inventory BPI
Heart-failure specific measures Assessed at Enrollment
Kansas City Cardiomyopathy Questionnaire KCCQ
Psycho-social situation cognitive function Assessed at Enrollment
Physicians Health Questionnaire depression screen PHQ-9 Mini-cog Social functioning ENRICHD Social Support Inventory ESSI The Short Physical Performance Battery SPPB will be collected on 12 of subjects Clinical Data from medical record Patients medical condition Charleson Comorbidity Scale prior diagnosis of Diabetes Mellitus Cancer Chronic lung disease Coronary Artery Disease Cirrhosis
Known painful conditions osteoarthritis chronic back pain CAD with angina neuropathy others Physical examination Jugular Venous Pressure as per NIH trial standards base of neck ½ way up jaw level edema 1 0-14 depression 2 14-12 3 12-1 4 1 Blood pressure Respiratory rate Heart rate rhythm Echocardiogram data Date of most recent Echocardiogram LVEF LVDD LA dimension presence of valvular disease measure of severity for example if aortic stenosis then valve area if mitral regurgitation then 1-4 Laboratory data BUN CR Na HgB BNP hemoglobin
Demographic Data Age Sex Race ethnic identification Marital Status Living situation alone with family with other person employment status employed self-employed retired unemployed due to disability highest level of education religious affiliation annual household income insurance none Medicare Medicaid Veterans Administration Kaiser other Health Maintenance Organization private fee for service
Medications Treatment Assessed at Enrollment and 1-2 weeks later Heart Failure medications ACEI ARB β-blocker digoxin spironolactone eplerenone loop diuretics nesiritide inotropes warfarin Analgesics NSAIDs Cox-2 inhibitors Aspirin Acetaminophen Tramadol Opioids Antidepressants SSRI Tricyclics Psychostimulants other Topical agents acetylsalicylate acid creams capsaicin Physical therapy cold heat other modalities Statistical Evaluation We will report frequencies of pain in total frequencies of levels of severity interference in activities of pain by occasional versus frequent or constant pain and by location with descriptive statistics To the extent the etiology of pain is identified this will be reported with descriptive statistics Pearson product-moment correlation coefficients t-test and frequency statistics Chi-square and Fishers Exact test will be used to evaluate associations between pain presence severity and type and demographic and clinical variables If possible comparison will be made between patients without pain and those with pain using chi-square tests and t-test
A multivariate analysis of variance will be used to assess relationship between pain and measures of heart failure severity social support depression and symptom distress other than pain
Differences in Pain measures will be assessed between enrollment and the second assessment 1-2 weeks later and changes will be correlated with changes in treatment for pain Geographic locations of pain will be mapped using the body diagram on the BPI to identify areas of greatest frequency
We will use standardized tools to survey patients as follows
Pain other symptoms Assessed at enrollment and one-two weeks later
Memorial Symptom Assessment Scale- HF MSAS-HF Short-form McGill pain questionnaire SF-MPQ Brief Pain Inventory BPI
Heart-failure specific measures Assessed at Enrollment
Kansas City Cardiomyopathy Questionnaire KCCQ
Psycho-social situation cognitive function Assessed at Enrollment
Physicians Health Questionnaire depression screen PHQ-9 Mini-cog Social functioning ENRICHD Social Support Inventory ESSI The Short Physical Performance Battery SPPB will be collected on 12 of subjects Clinical Data from medical record Patients medical condition Charleson Comorbidity Scale prior diagnosis of Diabetes Mellitus Cancer Chronic lung disease Coronary Artery Disease Cirrhosis
Known painful conditions osteoarthritis chronic back pain CAD with angina neuropathy others Physical examination Jugular Venous Pressure as per NIH trial standards base of neck ½ way up jaw level edema 1 0-14 depression 2 14-12 3 12-1 4 1 Blood pressure Respiratory rate Heart rate rhythm Echocardiogram data Date of most recent Echocardiogram LVEF LVDD LA dimension presence of valvular disease measure of severity for example if aortic stenosis then valve area if mitral regurgitation then 1-4 Laboratory data BUN CR Na HgB BNP hemoglobin
Demographic Data Age Sex Race ethnic identification Marital Status Living situation alone with family with other person employment status employed self-employed retired unemployed due to disability highest level of education religious affiliation annual household income insurance none Medicare Medicaid Veterans Administration Kaiser other Health Maintenance Organization private fee for service
Medications Treatment Assessed at Enrollment and 1-2 weeks later Heart Failure medications ACEI ARB β-blocker digoxin spironolactone eplerenone loop diuretics nesiritide inotropes warfarin Analgesics NSAIDs Cox-2 inhibitors Aspirin Acetaminophen Tramadol Opioids Antidepressants SSRI Tricyclics Psychostimulants other Topical agents acetylsalicylate acid creams capsaicin Physical therapy cold heat other modalities Statistical Evaluation We will report frequencies of pain in total frequencies of levels of severity interference in activities of pain by occasional versus frequent or constant pain and by location with descriptive statistics To the extent the etiology of pain is identified this will be reported with descriptive statistics Pearson product-moment correlation coefficients t-test and frequency statistics Chi-square and Fishers Exact test will be used to evaluate associations between pain presence severity and type and demographic and clinical variables If possible comparison will be made between patients without pain and those with pain using chi-square tests and t-test
A multivariate analysis of variance will be used to assess relationship between pain and measures of heart failure severity social support depression and symptom distress other than pain
Differences in Pain measures will be assessed between enrollment and the second assessment 1-2 weeks later and changes will be correlated with changes in treatment for pain Geographic locations of pain will be mapped using the body diagram on the BPI to identify areas of greatest frequency
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