Status:
COMPLETED
CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Reliant Medical Group
University of Massachusetts, Amherst
Conditions:
Hypertension
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This project will develop and test a low-cost approach to using health information technology and home monitoring aimed at improving care for chronic conditions, with low barriers to adoption in a wid...
Detailed Description
This project will develop and test a low-cost approach to using health information technology (HIT), aimed at improving the effectiveness and cost-effectiveness of care for chronic health conditions t...
Eligibility Criteria
Inclusion
- diagnoses of both diabetes mellitus (MODIFICATION 2/13: prediabetes) and hypertension
- uncontrolled hypertension (mean of up to most recent 3 clinic BPs in previous 6 months with SBP\>=145 and/or DBP\>=85) AND mean of 3 readings taken at intake visit meeting same criterion
Exclusion
- end-stage renal disease
- management of blood pressure by provider other than primary care provider (PCP)
- pregnancy/gestational diabetes
- terminal illness
- diagnosed or probable (based on screen) dementia
- active psychosis
- moderate-severe mental retardation
- indication by PCP that patient would be inappropriate for study
- planning to leave Reliant Medical Group (formerly Fallon Clinic) during the coming year
- MODIFICATIONS: due to a smaller pool of eligible participants and lower enrollment than anticipated, eligibility for the study has been expanded as of February 2013 to include persons with "prediabetes," defined by either a coded diagnosis of abnormal glucose (International Classification of Diseases \[ICD\] 9-CM codes 790.2x) or a hemoglobin A1c laboratory value from 6.0%-6.4%. For this group, the DBP eligibility criterion will be a mean, as defined above, of \>=95, as target BP for this group is 140/90, not 140/80.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01416766
Start Date
August 1 2011
End Date
July 1 2015
Last Update
September 16 2015
Active Locations (1)
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1
Reliant Medical Group
Worcester, Massachusetts, United States, 01605