Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes
Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedNovember 18, 2014
November 1, 2014
1.5 years
October 20, 2012
November 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Lab test
Change from baseline to 6 months
Secondary Outcomes (3)
Empowerment
Change from baseline to 3 months
Behavior Change
Change from baseline to 3 months
Knowledge
Change from baseline to 3 months
Other Outcomes (2)
Feasibility of incorporating the intervention into the existing program
3 months
Participant engagement with telehealth technology
3 months
Study Arms (2)
Control-usual care
NO INTERVENTIONNurse care coordination in a telephonic diabetes disease management program
Intervention paired testing and remote monitoring
EXPERIMENTALTelehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sutter Healthlead
- LifeScancollaborator
- GE Healthcarecollaborator
- University of California, Daviscollaborator
Study Sites (1)
Sutter Health
Sacramento, California, 95833, United States
Related Publications (1)
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.
PMID: 26199142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Diabetes Clinical Nurse Specialist
Study Record Dates
First Submitted
October 20, 2012
First Posted
October 29, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 18, 2014
Record last verified: 2014-11