Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2005-10-31
2007-12-31
Brief Summary
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Detailed Description
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The lower-intensity initiative ("Care Coordination") will consist of care coordination in the form of monthly monitoring of subjects via telephone by the study's research nurse who will refer the subject to his/her 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 (i.e., 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 subject's 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 (i.e., 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Care Coordination
Care Coordination with monthly follow-up by a diabetes nurse educator
Care Coordination
Care coordination with monthly follow-up by a diabetes nurse educator
Home Telemedicine
Active Care Management with Home Telemedicine
Home Telemedicine
Active care management by a nurse practitioner using home telemedicine
Interventions
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Care Coordination
Care coordination with monthly follow-up by a diabetes nurse educator
Home Telemedicine
Active care management by a nurse practitioner using home telemedicine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. diagnosed with diabetes mellitus with at least 12 months of ongoing pharmacologic treatment (at least one oral hypoglycemic agent, insulin, or both)
3. born in 1926 or later
4. have an HbA1c level \>/= 8.0% at the last assessment (between 6/1/04 and 12/31/05)
5. have an HbA1c level \>/= 7.5% (by finger stick) at the time of enrollment
6. mentally competent to give informed consent
Exclusion Criteria
2. metastatic or inoperable cancer
3. Child-Pugh Class B or C end-stage liver disease
4. HIV/AIDS
5. end-stage renal disease requiring dialysis
6. ongoing home oxygen therapy
7. a history of major organ transplant (i.e., heart, lung, kidney, liver)
8. residence in an institution (e.g. nursing home, personal care home, or prison)
9. incompatible telephone service (i.e., either none or digital)
10. concurrent participation in any other research protocol
18 Years
79 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Responsible Party
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VA Pittsburgh Healthcare System
Principal Investigators
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Frederick R DeRubertis, MD
Role: PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System
Locations
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VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Countries
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References
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Stone RA, Sevick MA, Rao RH, Macpherson DS, Cheng C, Kim S, Hough LJ, DeRubertis FR. The Diabetes Telemonitoring Study Extension: an exploratory randomized comparison of alternative interventions to maintain glycemic control after withdrawal of diabetes home telemonitoring. J Am Med Inform Assoc. 2012 Nov-Dec;19(6):973-9. doi: 10.1136/amiajnl-2012-000815. Epub 2012 May 19.
Other Identifiers
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02324; 02489
Identifier Type: -
Identifier Source: org_study_id