Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119054
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-07-01
Brief Title:
Effectiveness of Home-Based Health Messaging for Patients With Hypertension and Diabetes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effectiveness of Care Coordination in Managing Medically Complex Patients
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Patients treated at Veterans Affairs VA medical centers are older and have multiple chronic conditions Two of the most common conditions in the VA population are hypertension HTN and Type 2 diabetes DM Unfortunately DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes Thus serious complications and long-term adverse outcomes are common in both of these conditions
Home telehealth is a general term used to describe the delivery of health care services to the patients home using audio video or other telecommunications technologies Although home telehealth offers a number of theoretical advantages few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit Furthermore projects to date have focused on special populations eg heart failure or mental illnesses Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses there is a need for population-based studies addressing the needs of patients in primary care settings
Care coordination as defined by the VHA Office of Care Coordination is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention investigation and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources Care coordination embeds technology into a care management process This results in the right care at the right time in the right place
Home telehealth is a general term used to describe the delivery of health care services to the patients home using audio video or other telecommunications technologies Although home telehealth offers a number of theoretical advantages few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit Furthermore projects to date have focused on special populations eg heart failure or mental illnesses Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses there is a need for population-based studies addressing the needs of patients in primary care settings
Care coordination as defined by the VHA Office of Care Coordination is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention investigation and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources Care coordination embeds technology into a care management process This results in the right care at the right time in the right place
Detailed Description:
Patients treated at Veterans Affairs VA medical centers are older and have multiple chronic conditions Two of the most common conditions in the VA population are hypertension HTN and Type 2 diabetes DM Unfortunately DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes Thus serious complications and long-term adverse outcomes are common in both of these conditions
Home telehealth is a general term used to describe the delivery of health care services to the patients home using audio video or other telecommunications technologies Although home telehealth offers a number of theoretical advantages few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit Furthermore projects to date have focused on special populations eg heart failure or mental illnesses Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses there is a need for population-based studies addressing the needs of patients in primary care settings
Care coordination as defined by the VHA Office of Care Coordination is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention investigation and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources Care coordination embeds technology into a care management process This results in the right care at the right time in the right placeThe primary objective of the proposed study is to evaluate the efficacy of care coordination in improving outcomes in veterans with co-morbid DM and HTN the two most common chronic conditions seen in VA Primary Care clinics The specific aim is to compare outcomes of patients who receive the care coordination intervention to outcomes of patients who receive usual care Three hypotheses will be tested Compared to subjects who receive usual care subjects who receive the care coordination intervention will have 1 improved clinical measures hemoglobin A1c HbA1c and systolic blood pressure SBP at 6 and 12 months after study enrollment 2 improved disease self-management knowledge self-efficacy and adherence at 6 and 12 months after study enrollment and 3 improved quality of life and satisfaction with care at 6 and 12 months after study enrollmentSubjects wererecruited from VA Primary Care clinic rolls 302 subjects were randomized to three groups low-intensity monitoring plus nurse care management intervention n102 high-intensity monitoring plus nurse care management intervention n93 and usual care n107 In both intervention groups patients transmitted vital signs daily In addition the low intensity group answered two general health questions the high intensity group responded to a complete range of questions focused on diabetes and hypertension and received educational tips The intervention groups participated in the protocol for 6 months following enrollment Data were collected at baseline and at 6 and 12 months including measures of clinical outcomes quality of life knowledge adherence self-efficacy and satisfaction with care In addition to these measures data were collected to estimate the cost of the home telehealth intervention Most subjects were male 98 Caucasians 96 with a mean age of 68 years range 40-89 years
Home telehealth is a general term used to describe the delivery of health care services to the patients home using audio video or other telecommunications technologies Although home telehealth offers a number of theoretical advantages few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit Furthermore projects to date have focused on special populations eg heart failure or mental illnesses Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses there is a need for population-based studies addressing the needs of patients in primary care settings
Care coordination as defined by the VHA Office of Care Coordination is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention investigation and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources Care coordination embeds technology into a care management process This results in the right care at the right time in the right placeThe primary objective of the proposed study is to evaluate the efficacy of care coordination in improving outcomes in veterans with co-morbid DM and HTN the two most common chronic conditions seen in VA Primary Care clinics The specific aim is to compare outcomes of patients who receive the care coordination intervention to outcomes of patients who receive usual care Three hypotheses will be tested Compared to subjects who receive usual care subjects who receive the care coordination intervention will have 1 improved clinical measures hemoglobin A1c HbA1c and systolic blood pressure SBP at 6 and 12 months after study enrollment 2 improved disease self-management knowledge self-efficacy and adherence at 6 and 12 months after study enrollment and 3 improved quality of life and satisfaction with care at 6 and 12 months after study enrollmentSubjects wererecruited from VA Primary Care clinic rolls 302 subjects were randomized to three groups low-intensity monitoring plus nurse care management intervention n102 high-intensity monitoring plus nurse care management intervention n93 and usual care n107 In both intervention groups patients transmitted vital signs daily In addition the low intensity group answered two general health questions the high intensity group responded to a complete range of questions focused on diabetes and hypertension and received educational tips The intervention groups participated in the protocol for 6 months following enrollment Data were collected at baseline and at 6 and 12 months including measures of clinical outcomes quality of life knowledge adherence self-efficacy and satisfaction with care In addition to these measures data were collected to estimate the cost of the home telehealth intervention Most subjects were male 98 Caucasians 96 with a mean age of 68 years range 40-89 years
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