Clinical trial NCT01715649: Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes
Official title: Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
self-management
remote patient monitoring
Lead sponsor: Sutter Health
Sponsor class: OTHER
Collaborators: name: LifeScan
name: GE Healthcare
name: University of California, Davis
First posted: 2012-10-29
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the Internet - to connect patients remotely with their healthcare team from their homes. The investigators hope to learn more about improving healthy behaviors and blood glucose among persons with diabetes using telehealth remote patient monitoring technology to connect directly with nurse care coordinators.

The purpose of this study is to evaluate a process for improving blood glucose and healthy behaviors among people with type 2 diabetes using telehealth remote patient monitoring technology with nurse care coordinators. Some of the people in this study will work with a nurse care coordinator who will review your blood glucose weekly and call you at home every month for 3 months, while some of the people in this study will simply receive their normal care. At the end of the study, every participant will be asked questions about how they feel about their health care.


Eligibility criteria: Inclusion Criteria:

* Enrolled in diabetes disease management program
* ages 30-70
* HbA1c between 7.5% and 10.9% in the previous six months
* an Internet or 3G connection and email address;
* a working phone line (land line or cellular); and
* ability to read and understand the English language.

Exclusion Criteria:

* taking insulin;
* inability to independently engage in self-management behaviors (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment);
* severe complications, which would preclude achieving an HbA1c goal of 7% including diagnosis of the following:
* severe stroke;
* heart failure;
* end-stage renal disease;
* kidney dialysis; and
* legally blind.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Empowerment
timeFrame: Change from baseline to 3 months
measure: Behavior Change
timeFrame: Change from baseline to 3 months
measure: Knowledge
timeFrame: Change from baseline to 3 months
Other outcomes:
measure: Feasibility of incorporating the intervention into the existing program
timeFrame: 3 months
measure: Participant engagement with telehealth technology
timeFrame: 3 months
Locations:
city: Sacramento
country: United States
facility: Sutter Health
state: California
Study officials:
References:
citation: Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes. J Med Internet Res. 2015 Jul 21;17(7):e178. doi: 10.2196/jmir.4112.