Technology-assisted Case Management in Adults With Type 2 Diabetes (TACM-DM)

This study is currently recruiting participants.
Verified May 2013 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01373489
First received: June 13, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Diabetes
Device: Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hemoglobin A1C: Blood specimens will be obtained at baseline, 3 and 6 months visits by the Registered Nurse (RN). About 10cc of blood will be drawn and sent to the laboratory for hemoglobin A1C.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood pressure measurement: Blood pressure readings will be obtained at baseline, 3 and 6 months visits by the RN using automated BP monitors (OMRON IntelliSenseTM HEM-907XL) with the patient seated comfortably for 5 minutes prior to the measurements, following the American Heart Association guidelines. The device will be programmed to take 5 readings at 2 minute intervals, after an initial rest period of 3 minutes.

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of Life: The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status. It is a widely used brief (1-page, 2-minute) and comprehensive survey that yields summary physical (PCS-12) and mental health (MCS-12) outcome scores that are interchangeable with those from the SF-36 in both general and specific populations. The SF-12 items reproduce at least 90% of the variance in PCS-36 and MCS-36 scores.


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.
Active Comparator: Technology-assisted Case Management (TACM)
This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.
Device: Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System)
The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse case manager will have access to a secure server to which the uploaded measurements are stored in real time.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373489

Contacts
Contact: Wanda Jones, RN 843-876-1495 romanchw@musc.edu
Contact: Joni L Strom, MD, MPH 843-792-0906 stromjl@musc.edu

Locations
United States, South Carolina
Franklin C. Fetter Family Health Center, Inc. Recruiting
Charleston, South Carolina, United States, 29403
Contact: Wanda Jones, RN    843-876-1495    romanchw@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Leonard E Egede, MD, MS Medical University of South Carolina
  More Information

Publications:
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01373489     History of Changes
Other Study ID Numbers: Pro00009204, Department of Defense
Study First Received: June 13, 2011
Last Updated: May 20, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
type 2 diabetes
nurse case management
telemedicine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014