Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care
The usual care group received the current standards of care at the study clinics.
Technology Assisted Case Management
The TACM group used the FORA 2-in-1 Telehealth system for diabetes management intervention to link a case manager to patients with poorly controlled type 2 diabetes in real time.
Intervention: Technology-Assisted Case Management (Behavioral)
Outcomes
Primary Outcomes
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Time Frame: 6 months post randomization
Hemoglobin A1c (HbA1c) was measured at 6 months post randomization
Secondary Outcomes
No secondary outcomes reported
Investigators
Leonard Ehianu Egede
Professor & Chair, Department of Medicine
State University of New York at Buffalo