Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057057
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
Telephone Intervention in Heart Failure Patients
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Randomized Trial of a Telephone Intervention in Heart Failure Patients
Status:
COMPLETED
Status Verified Date:
2007-02
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:
In addition to medical treatment for heart failure HF a variety of non-pharmacological interventions have been demonstrated to benefit these patients Some of these include systems for weight monitoring and medication reminders exercise programs and individually tailored evaluation and treatment plans with dietitians social workers psychologists and nurse case managers While many of these approaches have been shown to increase adherence to medication guidelines and result in decreased health care utilization most rely heavily on a large team of specialized health care providers It remains unknown whether or not an intervention with a lower intensity of specialized care using sophisticated automated computer tracking and Interactive Voice Response IVR techniques can impact the care of HF patients
Detailed Description:
Background
In addition to medical treatment for heart failure HF a variety of non-pharmacological interventions have been demonstrated to benefit these patients Some of these include systems for weight monitoring and medication reminders exercise programs and individually tailored evaluation and treatment plans with dietitians social workers psychologists and nurse case managers While many of these approaches have been shown to increase adherence to medication guidelines and result in decreased health care utilization most rely heavily on a large team of specialized health care providers It remains unknown whether or not an intervention with a lower intensity of specialized care using sophisticated automated computer tracking and Interactive Voice Response IVR techniques can impact the care of HF patients
Objectives
The primary hypothesis of this study is that Heart Failure Telephone Intervention HearT-I will decrease hospitalizations and clinic visits in the veteran population with heart failure
Methods
The HearT-I intervention consists of three components 1 computer-initiated medication refill and clinic appointment reminders 2 IVR access to educational modules and 3 weekly computer-initiated phone calls with a series of questions regarding weight and symptoms Four hundred eighty-eight HF patients NYHA class II-IV will be randomized to HearT-I intervention vs usual care Upon enrollment all patients will complete questionnaires assessing HF knowledge behavior self-efficacy and perceptions of HF health care and HF related Quality of Life Kansas City Cardiomyopathy Questionnaire KCCQ Both groups also will receive a digital scale educational materials view an educational video about HF and perform a six-minute walk test We will test the hypothesis that the HearT-I intervention will decrease health care utilization as measured by hospitalizations and unscheduled outpatient visits for HF over one year Secondary endpoints include KCCQ score patient satisfaction adherence to medications and general knowledge of heart failure and its management
Status
Preliminary data analyisis has begun
In addition to medical treatment for heart failure HF a variety of non-pharmacological interventions have been demonstrated to benefit these patients Some of these include systems for weight monitoring and medication reminders exercise programs and individually tailored evaluation and treatment plans with dietitians social workers psychologists and nurse case managers While many of these approaches have been shown to increase adherence to medication guidelines and result in decreased health care utilization most rely heavily on a large team of specialized health care providers It remains unknown whether or not an intervention with a lower intensity of specialized care using sophisticated automated computer tracking and Interactive Voice Response IVR techniques can impact the care of HF patients
Objectives
The primary hypothesis of this study is that Heart Failure Telephone Intervention HearT-I will decrease hospitalizations and clinic visits in the veteran population with heart failure
Methods
The HearT-I intervention consists of three components 1 computer-initiated medication refill and clinic appointment reminders 2 IVR access to educational modules and 3 weekly computer-initiated phone calls with a series of questions regarding weight and symptoms Four hundred eighty-eight HF patients NYHA class II-IV will be randomized to HearT-I intervention vs usual care Upon enrollment all patients will complete questionnaires assessing HF knowledge behavior self-efficacy and perceptions of HF health care and HF related Quality of Life Kansas City Cardiomyopathy Questionnaire KCCQ Both groups also will receive a digital scale educational materials view an educational video about HF and perform a six-minute walk test We will test the hypothesis that the HearT-I intervention will decrease health care utilization as measured by hospitalizations and unscheduled outpatient visits for HF over one year Secondary endpoints include KCCQ score patient satisfaction adherence to medications and general knowledge of heart failure and its management
Status
Preliminary data analyisis has begun
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