Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT01715649
• Lead Sponsor: Sutter Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-20
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-29
• Study Start: 2012-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Change from baseline to 6 months	Lab test

Secondary Outcome Measures

Name	Time	Method
Empowerment	Change from baseline to 3 months	Diabetes Empowerment Scale completed by survey
Behavior Change	Change from baseline to 3 months	Summary of Diabetes Self-Care Behaviors scale completed by survey
Knowledge	Change from baseline to 3 months	Michigan Diabetes Knowledge Test completed by survey

Trial Locations

Locations (1)

Sutter Health; 🇺🇸 Sacramento, California, United States