Technology-assisted Case Management in Adults With Type 2 Diabetes (TACM-DM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01373489|
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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.
- Hemoglobin A1c [ Time Frame: 6 months ]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.
- Blood Pressure [ Time Frame: 6 months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373489
|United States, South Carolina|
|Franklin C. Fetter Family Health Center, Inc.|
|Charleston, South Carolina, United States, 29403|
|Principal Investigator:||Leonard E Egede, MD, MS||Medical University of South Carolina|