Technology-assisted Case Management in Adults With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Technology-Assisted Case Management

• Registration Number: NCT01373489
• Lead Sponsor: State University of New York at Buffalo

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 Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Study Start: 2011-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2018-06-12
• Results First Submitted QC: 2018-08-16
• Results First Posted: 2018-08-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology Assisted Case Management	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization	6 months post randomization	Hemoglobin A1c (HbA1c) was measured at 6 months post randomization

Trial Locations

Locations (1)

Franklin C. Fetter Family Health Center, Inc.; 🇺🇸 Charleston, South Carolina, United States