Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245882
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2005-10-27
Brief Title:
The Diabetes Telemonitoring DiaTel Study
Sponsor:
United States Department of Defense
Organization:
VA Pittsburgh Healthcare System
Study Overview
Official Title:
The Diabetes Telemonitoring DiaTel Study
Status:
COMPLETED
Status Verified Date:
2012-09
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:
DiaTel
Brief Summary:
The purpose of this research study is to compare two different methods of helping veterans with diabetes better manage their disease This study will compare an Active Care Management method using home-based technology and self-monitoring techniques with a lower-intensity Care Coordination method based on monthly telephone contact with a nurse
Detailed Description:
The objectives of this study are to design implement and evaluate two medical care initiatives of different levels of intensity for veterans with diabetes and suboptimal glycemic control The higher-intensity initiative Active Care Management will use home-based technology that enables home messaging and reminders for compliance with recommended guidelines for treatment as well as self-monitoring of blood glucose blood pressure and weight Data will be transmitted to health care providers This initiative will feature active care management including changes in medication andor diet implemented by the studys certified registered nurse practitioner under the supervision of a study physician in collaboration with the subjects primary care provider PCP
The lower-intensity initiative Care Coordination will consist of care coordination in the form of monthly monitoring of subjects via telephone by the studys research nurse who will refer the subject to hisher PCP as needed for additional care Both initiatives represent a supplementation to current usual care practices for the treatment of diabetes in the VA
The objective of Phase Two of the study is to determine the appropriate level of subsequent management required for sustaining glycemic blood pressure BP and lipid control among subjects randomized in Phase One to care coordination CC or to active care management ACM CC involved monthly telephone calls from a diabetes nurse RN whereas ACM involved home messaging and monitoring with the Viterion TeleHealth System plus active management of glycemia BP and lipids by a nurse practitioner NP ACM subjects transmitted blood glucose BP and weight measurements daily for review and intervention if necessary by the NP
Subjects who complete Phase One and consent to participate in Phase Two will be randomized to subsequent management at the same or lower intensity and followed for an additional six months Phase One ACM subjects will be randomized in Phase Two to either care coordination with monthly telephone calls ie ACM-to-CC or care coordination with monthly telephone calls plus home telehealth monitoring but with no active management by the NP ACM-to-CCHT CCHT subjects will continue to transmit home blood glucose BP and weight daily to the project office but abnormal values will be referred to their primary care provider PCP for action Phase One CC subjects will be randomized to either continued care coordination with monthly telephone calls CC-to-CC or referral back to their PCP for usual care CC-to-UC Randomization within both groups for Phase Two will be stratified according to HbA1c 7 or 7 at the conclusion of the subjects six-month participation in Phase One
The primary aim of Phase Two is to assess whether glycemic blood pressure and lipid control at the end of an additional six months of follow-up differs for patients randomized to the four groups specified above ie ACM-to-CC ACM-to-CCHT CC-to-CC and CC-to-UC adjusted for their corresponding HbA1c levels at the end of Phase One
The lower-intensity initiative Care Coordination will consist of care coordination in the form of monthly monitoring of subjects via telephone by the studys research nurse who will refer the subject to hisher PCP as needed for additional care Both initiatives represent a supplementation to current usual care practices for the treatment of diabetes in the VA
The objective of Phase Two of the study is to determine the appropriate level of subsequent management required for sustaining glycemic blood pressure BP and lipid control among subjects randomized in Phase One to care coordination CC or to active care management ACM CC involved monthly telephone calls from a diabetes nurse RN whereas ACM involved home messaging and monitoring with the Viterion TeleHealth System plus active management of glycemia BP and lipids by a nurse practitioner NP ACM subjects transmitted blood glucose BP and weight measurements daily for review and intervention if necessary by the NP
Subjects who complete Phase One and consent to participate in Phase Two will be randomized to subsequent management at the same or lower intensity and followed for an additional six months Phase One ACM subjects will be randomized in Phase Two to either care coordination with monthly telephone calls ie ACM-to-CC or care coordination with monthly telephone calls plus home telehealth monitoring but with no active management by the NP ACM-to-CCHT CCHT subjects will continue to transmit home blood glucose BP and weight daily to the project office but abnormal values will be referred to their primary care provider PCP for action Phase One CC subjects will be randomized to either continued care coordination with monthly telephone calls CC-to-CC or referral back to their PCP for usual care CC-to-UC Randomization within both groups for Phase Two will be stratified according to HbA1c 7 or 7 at the conclusion of the subjects six-month participation in Phase One
The primary aim of Phase Two is to assess whether glycemic blood pressure and lipid control at the end of an additional six months of follow-up differs for patients randomized to the four groups specified above ie ACM-to-CC ACM-to-CCHT CC-to-CC and CC-to-UC adjusted for their corresponding HbA1c levels at the end of Phase One
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