HypertensionCONDUIT-HIDNCT01416766
CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
A study testing Self-monitoring-nurse-primary care provider feedback loop in people with Hypertension and Diabetes Mellitus, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- Self-monitoring-nurse-primary care provider feedback loop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Reliant Medical Group
Worcester, Massachusetts, 01605
About this study
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.
Read the 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 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.
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- Self-monitoring-nurse-primary care provider feedback loop
- Keywords
- Blood Pressure Monitors, Medical Informatics, Disease Management, Comparative Effectiveness Research
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring-nurse-primary care provider feedback loopOther
Also called CONDUIT blood pressure intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Self-monitoring-nurse-primary care provider feedback loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
We will compare changes in the Medication Possession Ratio for antihypertensive medications for the 6 months prior to study entry and the 6 months prior to study exit for the subset of participants for whom insurance claims give us complete data on prescription fills.
Measured: 6 months prior to study entry and 6 months prior to study exit
Self-reported medication adherence
Change in self-reported medication adherence, based on: 1) the modified Morisky scale and 2) a visual analog scale (Walsh).
Measured: At entry (day 1) and 1 year later, at exit
Technology use
We will measure use of home/office/other personal computers to upload BP readings over the internet vs. bringing BP monitor to clinic and uploading data vs. calling/mailing/faxing readings (offered to those not doing either of the first 2 after 2-3 months). We intend to offer delayed entry after the exit to control subjects and will assess their use over the next 3-6 months.
Measured: Continuous over course of study; final measurement at exit interview for intervention subjects & 6 mos. after exit for controls
Health care utilization
We will measure counts of Reliant Medical Group visits and hospitalizations. Number of antihypertensive medications and post/pre change will be compared for control vs. intervention participants. We will also compare health care costs, as represented by billed charges; complete charges are expected to be available for ~70% of participants; clinic-only charges will be compared for the remainder.
Measured: Enrollment through exit 1 year later
Satisfaction
Participant satisfaction with care will be measured using Consumer Assessment of Healthcare Providers and Systems (CAHPS) clinician and group survey questions.
Measured: At entry (day 1) and 1 year later, at exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Medical Group, University of Massachusetts, Amherst
- Responsible party
- Principal investigator, Barry Saver, University of Massachusetts, Worcester
- Investigators
- Barry G Saver, MD, MPH, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416766
- Sponsor's protocol ID
- CONDUIT-001
- Other IDs
- R18HS018461
- Acronym
- CONDUIT-HID
- Status last verified
- Sep 2015
- First submitted
- 3 Aug 2011
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23800678
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
- ClinicalTrials.gov ID
- NCT01416766
- Acronym / sponsor ID
- CONDUIT-HID / CONDUIT-001
- Conditions
- Hypertension, Diabetes Mellitus
- Keywords
- Blood Pressure Monitors, Medical Informatics, Disease Management, Comparative Effectiveness Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Reliant Medical Group, University of Massachusetts, Amherst
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Self-monitoring-nurse-primary care provider feedback loopSelf-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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-monitoring-nurse-primary care provider feedback loopAlso: CONDUIT blood pressure interventionIntervention 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. | Other | Intervention |
Primary outcome
Change in blood pressure (BP)
Time frame: At entry (day 1) and 1 year later; secondarily, electronic health record (EHR)-based readings prior to entry and one year later
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.
5 secondary outcomes
Refill adherence
Time frame: 6 months prior to study entry and 6 months prior to study exit
Self-reported medication adherence
Time frame: At entry (day 1) and 1 year later, at exit
Technology use
Time frame: Continuous over course of study; final measurement at exit interview for intervention subjects & 6 mos. after exit for controls
Health care utilization
Time frame: Enrollment through exit 1 year later
Satisfaction
Time frame: At entry (day 1) and 1 year later, at exit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Results publication: PubMed 23800678Marquard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry G Saver, MD, MPH principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring-nurse-primary care provider feedback loop in people with Hypertension and Diabetes Mellitus, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (BP) (time frame: At entry (day 1) and 1 year later; secondarily, electronic health record (EHR)-based readings prior to entry and one year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.