CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes

NCT01416766 | Completed DMC

• 2 other identifiers: CONDUIT-001R18HS018461
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypertension; Diabetes Mellitus

Keywords

Blood Pressure Monitors; Medical Informatics; Disease Management; Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure (BP)

  We will assess differences in changes in systolic BP (SBP) and diastolic BP (DBP) measured at study intake and 1 year later at exit. We will also evaluate changes in mean EHR BP readings prior to study entry and in the 3 months before study exit. We will also assess the primary outcome in terms of % of intervention vs. control participants achieving control (originally proposed as mean of 3 exit readings \<130 SBP and 80 DBP but now revised to 140 SBP and 80 DBP due to new evidence and change in the Healthcare Effectiveness Data and Information Set (HEDIS) measure for 2011). NOTE: For eligible participant group added 2/13, "prediabetic" patients, DBP control will be judged as mean \<90mmHg as target BP for these groups is 140/90.

  At entry (day 1) and 1 year later; secondarily, electronic health record (EHR)-based readings prior to entry and one year later

Secondary Outcomes (5)

• Refill adherence

  6 months prior to study entry and 6 months prior to study exit

• Self-reported medication adherence

  At entry (day 1) and 1 year later, at exit

• Technology use

  Continuous over course of study; final measurement at exit interview for intervention subjects & 6 mos. after exit for controls

• Health care utilization

  Enrollment through exit 1 year later

• Satisfaction

  At entry (day 1) and 1 year later, at exit

Study Arms (2)

Control

NO INTERVENTION

Control participants will receive usual care during their year of enrollment. At enrollment, prior to randomization, they will be informed that, if randomized to control status, they will be offered a free BP monitor and the opportunity to receive the study intervention after completing the exit interview in 1 year.

Intervention

EXPERIMENTAL

Self-monitoring-nurse-primary care provider feedback loop After randomization, intervention participants will receive the intervention (free home BP monitor, assistance setting up to upload BP readings from home/work or clinic computer; feedback loop with nurse-driven protocols to manage uncontrolled hypertension and maintain control once attained).

Other: Self-monitoring-nurse-primary care provider feedback loop

Interventions

Self-monitoring-nurse-primary care provider feedback loop OTHER

Intervention participants will receive an Omron BP monitor and assistance in setting it up to upload BP data to Reliant Medical Group from a home/work or clinic-based computer. They will be encouraged to upload readings at least once/month. Diabetes management nurses will receive the readings and, if a participant's mean BP is not at target, will follow protocols to address this, contacting PCPs as indicated by protocols.

Also known as: CONDUIT blood pressure intervention

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Reliant Medical Group: collaborator
• University of Massachusetts, Amherst: collaborator

Study Sites (1)

Reliant Medical Group

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

• Marquard JL, Garber L, Saver B, Amster B, Kelleher M, Preusse P. Overcoming challenges integrating patient-generated data into the clinical EHR: lessons from the CONtrolling Disease Using Inexpensive IT--Hypertension in Diabetes (CONDUIT-HID) Project. Int J Med Inform. 2013 Oct;82(10):903-10. doi: 10.1016/j.ijmedinf.2013.04.009. Epub 2013 Jun 22.

  PMID: 23800678 RESULT

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Barry G Saver, MD, MPH

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 15, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

US (1)