Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes
This study is enrolling participants by invitation only.
Sponsor:
Sutter Health
Collaborators:
LifeScan
GE Healthcare
University of California, Davis
Information provided by (Responsible Party):
Deborah Greenwood, Sutter Health
ClinicalTrials.gov Identifier:
NCT01715649
First received: October 20, 2012
Last updated: October 24, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sutter Health:
Primary Outcome Measures:
- Hemoglobin A1c [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]Lab test
Secondary Outcome Measures:
- Empowerment [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]Diabetes Empowerment Scale completed by survey
- Behavior Change [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]Summary of Diabetes Self-Care Behaviors scale completed by survey
- Knowledge [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]Michigan Diabetes Knowledge Test completed by survey
Other Outcome Measures:
- Feasibility of incorporating the intervention into the existing program [ Time Frame: 3 months ] [ Designated as safety issue: No ]Will include # of participants that complete intervention, #of nurse hours required to analyze data and interact with participant,and number of technology issues impacting use
- Participant engagement with telehealth technology [ Time Frame: 3 months ] [ Designated as safety issue: No ]# of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control-usual care
Nurse care coordination in a telephonic diabetes disease management program
|
|
|
Experimental: Intervention
Telehealth remote patient monitoring, structured blood glucose and usual care
|
Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose
In the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose.
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Deborah Greenwood, Diabetes Clinical Nurse Specialist, Sutter Health |
| ClinicalTrials.gov Identifier: | NCT01715649 History of Changes |
| Other Study ID Numbers: | 1208042ex |
| Study First Received: | October 20, 2012 |
| Last Updated: | October 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sutter Health:
|
Type 2 diabetes self-management remote patient monitoring |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013