View Clinical Trial (Medical Research Study)
CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
| City: |
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Worcester |
| State: |
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Massachusetts |
| Zip Code: |
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01605 |
| Conditions: |
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Hypertension - Diabetes Mellitus |
| Purpose: |
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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 wide variety of settings - from large group practices using
state-of-the-art electronic health records to small practices with no more than a computer
with internet access. Success will lead to a cost-effective approach to improving control of
hypertension, both among individuals with diabetes and among non-diabetics, which can make a
substantial contribution to the health of the population of the United States as improving
hypertension control is estimated to have a greater population health benefit than most
other health interventions. Success will also set the stage for adaptation of this
intervention to a variety of other chronic health conditions and further substantial
improvements in the health of millions of Americans.
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| Study Summary: |
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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 that are amenable to home self-monitoring, that is easy to
disseminate. In contrast to many other HIT-based interventions, the investigators will
utilize commercial, off-the-shelf technology rather than custom, expensive HIT. The
investigators are using hypertension control among persons with diabetes as our test case
because there is documented need for improving control of hypertension in this high-risk
population and studies estimate that improving hypertension control in diabetes is more
cost-effective than most other medical interventions and possibly even cost-saving in direct
health care dollars. This high-value return on investment is important for encouraging
adoption, expansion, and dissemination of HIT innovations. Our intervention will involve
recruiting 400 persons with diabetes and uncontrolled hypertension receiving care through
Reliant Medical Group (RMG - formerly called Fallon Clinic). MODIFICATION (2/13) - Due
smaller than anticipated numbers of eligible persons and low enrollment, we are expanding
eligibility to include "prediabetics". Half of them will be randomly assigned to receive an
automated blood pressure (BP) monitor capable of uploading readings through a computer, plus
instruction on how to connect their monitors at home or in the clinic to upload their
information into a popular and free commercial personal health record (PHR) system. These
blood pressure data from the PHR will be transferred automatically into RMG's electronic
health record (EHR) system and will alert RMG's existing team of care management nurses.
Subjects whose blood pressure is uncontrolled will have their medication regimens
intensified by these nurses according to protocols. Intervention subjects will receive
regular outreach calls from the care management nurses if their blood pressure remains
uncontrolled or they are not periodically uploading blood pressure readings. After one year,
the investigators will compare outcomes between control and intervention subjects. Our
primary outcomes will be change in mean blood pressure and proportion of subjects with
controlled blood pressure. The investigators will also measure a range of secondary outcomes
including costs of the intervention, medication utilization, and a variety of
patient-reported outcomes. Furthermore, the investigators will interview and observe study
subjects and care providers to gain a better understanding of factors affecting uptake and
use of the intervention. The investigators will examine continued use of the intervention
after formal study participation ends and will also measure uptake of the intervention by
control subjects offered delayed entry at the end of the formal study. Lastly, the
investigators will compare our study and findings to other, recent studies using HIT to
improve hypertension control and develop a set of best practices and recommendations for
future efforts in this area.
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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.
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| NCT ID: |
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NCT01416766 |
| Primary Contact: |
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Principal Investigator
Barry G Saver, MD, MPH
University of Massachusetts, Worcester
Peggy Preusse, RN
Phone: 508-595-2219
Email: Peggy.Preusse@reliantmedicalgroup.org
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| Backup Contact: |
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Email: Diane.Kirk@reliantmedicalgroup.org
Diane Kirk, RN
Phone: 508-368-3929
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| Location Contact: |
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Worcester, Massachusetts 01605
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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