Clinical trial NCT01373489: Technology-assisted Case Management in Adults With Type 2 Diabetes
Official title: Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: type 2 diabetes
nurse case management
telemedicine
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-06-15
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.

Detailed description: The long-term goal is to develop a practical and sustainable system of diabetes management that will help low income patients achieve and maintain goals within established treatment guidelines regardless of geographic location. This randomized clinical trial will employ the innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management (TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM). The target population will be low income patients served in Federally Qualified Health Care Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care) and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6 months, with study visits at baseline, 3, and 6 months. The primary outcome will be Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be blood pressure control and quality of life (qol) at 6 months post-randomization.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years and receiving care within the Franklin C. Fetter Family Health Center
* Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
* Subject must be willing to use the FORA 2-in-1 system
* Subject must have a working land-line for the duration of the study in order to be able to upload the readings from the FORA 2-in-1 machine
* Subjects must be able to communicate in English

Exclusion Criteria:

* Mental confusion on interview suggesting significant dementia
* Participation in other diabetes clinical trials
* Alcohol or drug abuse/dependency using a screening questionnaire
* Active psychosis or acute mental disorder
* Life expectancy \<6 months
* Pregnant and/or lactating females

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
timeFrame: 6 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Franklin C. Fetter Family Health Center, Inc.
state: South Carolina
Study officials:
affiliation: Medical College of Wisconsin
name: Leonard E Egede, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egede LE, Strom JL, Fernandes J, Knapp RG, Rojugbokan A. Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial. Trials. 2011 Oct 20;12:231. doi: 10.1186/1745-6215-12-231.
citation: Egede LE, Williams JS, Voronca DC, Knapp RG, Fernandes JK. Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 Aug;19(8):476-482. doi: 10.1089/dia.2017.0006. Epub 2017 Jun 5.