Wednesday, April 13, 2011

Clinical Trial Using Telehealth

The “Peer-led and Telehealth Comparative Effectiveness Research (CER) Clinical Trial (NCT01307137) will study how Telehealth CER can help veterans prevent diabetes. The sponsor for the study is the South Florida Veterans Affairs Foundation for Research and Education.

The overall objective for this study is to implement evidence-based interventions to increase the adoption of findings from CER to prevent and manage diabetes in South Florida older veterans. The investigators will conduct a 12 month randomized controlled trial in older veterans with pre-diabetes.

The Clinical Trial has two specific interventions:

• Peer-led intervention—An expert patient in the peer-led intervention will provide effective support for patients and families to accelerate adoption of CER for diabetes prevention and management in the elderly

• Telehealth intervention—Participants in this group will receive mobile phones programmed to monitor specific clinical parameters and promote adoption of CER to prevent and manage diabetes in part based on the input from focus groups. The devices will display messages, tips, reminders and questions regarding healthy lifestyle and clinical parameters of diabetes

Primary outcomes include changes in self-efficacy, weight, and hemoglobin Alc. Secondary outcomes include changes in blood pressure, lipids, physical function, quality of life, and healthcare utilization. In addition, the potential racial/ethnic disparities affecting the adoption of CER to help patients prevent and manage diabetes will be evaluated.

The study is not yet open for participant recruitment but the estimated enrollment for the study is expected to be 85 veterans 60 years and older, diagnosed with diabetes or pre-diabetes, enrolled in the “Healthy Aging Regional Collaborative program, be able to operate a telemedicine device, respond to text queries, and use his/her glucose meter, a blood pressure monitor, and a scale for daily weights.

South Florida provides a unique setting to accelerate the adoption of CER evidence into practice and to address the obesity and diabetes challenges of the aging population. There are more than 800,000 multi-ethnic residents age 60 and over with many that have one or more chronic diseases living in the area. Additionally, a large number of older veterans that have or at high-risk for diabetes, currently receive care in the Miami VA Healthcare System.

For more information, go to