The Diabetes Telemonitoring (DiaTel) Study

Study Overview
=================
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 and/or diet implemented by the study's certified registered nurse practitioner under the supervision of a study physician in collaboration with the subject's 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 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.

Official Title
-----------------
The Diabetes Telemonitoring (DiaTel) Study

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: Care Coordination
* Behavioral: Home Telemedicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled for primary care at a VA Pittsburgh Healthcare System (VAPHS)site with at least one visit from June 1, 2004 through December 31, 2005 diagnosed with diabetes mellitus with at least 12 months of ongoing pharmacologic treatment (at least one oral hypoglycemic agent, insulin, or both) born in 1926 or later have an HbA1c level >/= 8.0% at the last assessment (between 6/1/04 and 12/31/05) have an HbA1c level >/= 7.5% (by finger stick) at the time of enrollment mentally competent to give informed consent Exclusion Criteria: one or more visits to the VAPHS Diabetes Clinic from June 1, 2004 through December 31, 2005 metastatic or inoperable cancer Child-Pugh Class B or C end-stage liver disease HIV/AIDS end-stage renal disease requiring dialysis ongoing home oxygen therapy a history of major organ transplant (i.e., heart, lung, kidney, liver) residence in an institution (e.g. nursing home, personal care home, or prison) incompatible telephone service (i.e., either none or digital) concurrent participation in any other research protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Care Coordination<br>Care Coordination with monthly follow-up by a diabetes nurse educator | Behavioral: Care Coordination<br>* Care coordination with monthly follow-up by a diabetes nurse educator<br>* Other names: Control;|
| Active Comparator: Home Telemedicine<br>Active Care Management with Home Telemedicine | Behavioral: Home Telemedicine<br>* Active care management by a nurse practitioner using home telemedicine<br>* Other names: Active Care Management;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in each cohort with HbA1c </= 7%, BP </= 130/80, LDL-cholesterol </= 100 mg/dl, and triglycerides </= 150 mg/dl at six months |  | 3 months, 6 months, 9 months, 12 months | 
| Proxy measures for cost of care (number of outpatient clinic visits, emergency room visits, hospital bed days, and pharmacy costs) |  | 3 months, 6 months, 9 months, 12 months | 
| For subjects not on insulin at enrollment, time to prescription of insulin |  | 6 months, 12 months | 
| For subjects on insulin at enrollment, time to change in dose and/or type of insulin |  | 6 months, 12 months | 
| Subject satisfaction with care |  | 6 months, 12 months | 
| Factors influencing adherence to diabetes regimen |  | 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telehealth, Veterans, Glycemic control, Active care management, Care coordination