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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34HL137659 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Higi | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators propose to conduct pilot studies to support an application to conduct a fully powered randomized trial of a text messaging intervention to increase the rate of blood pressure control, defined as <140/90 mmHg, among hypertensive individuals using health kiosk blood pressure devices. These pilot studies will include testing of the intervention, recruitment, enrollment, and data collection procedures, and of the web-based interactions between the data coordinating center and higi Sh llc (Chicago, IL), which is the company that installs and maintains the health care kiosks and associated software infrastructure. Completion of these pilot studies will provide preliminary data to support an application for a full scale randomized controlled study. Potential for adaption is high because of alignment of retail outlets, kiosk providers, and consumers for health, wellness, and self-care.
Cardiovascular disease (CVD) remains the leading cause of death in the U.S. as well as the leading cause of health care cost. Hypertension is the leading remediable risk factor for CVD in the U.S. and globally, with prevalence of 29% in U.S. adults. Recent data from NHANES indicate that blood pressure (BP) is not controlled, defined as <140/90 mmHg, in 48% of individuals in the U.S. with hypertension. Strategies to improve hypertension control have focused on the physician-patient interaction at the office visit, system factors in the health care provider system, and extension beyond the traditionally defined health care system. All have had some success but are limited by not reaching individuals outside the clinical encounter or by challenges of scale, scope, and standardization of blood pressure measurement outside the clinical setting. Retail outlet BP devices have the potential to address these limitations by providing free BP measurements to individuals outside the clinical setting and at all times the retail outlet is open. These automated devices are standardized and linked to software with the ability to collect data and provide information to individuals using these devices, thereby providing a platform for an intervention strategy. Higi is a privately owned company that provides health kiosks in retail outlets. Higi presently has 10,800 kiosks in the U.S. with 4,125 in Rite Aid pharmacies. More than 44 million BP measurements per year are obtained at higi kiosks. In the one-year period 7/1/15 to 6/30/16, approximately 727,000 individuals using higi kiosks recorded >3 systolic BP measurements >140/90 mmHg. The investigators propose to target this group using interactive text messaging to activate individuals to take actions to improve BP control. The primary endpoint will be BP control defined as <140/90 mmHg at 12 months post randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. |
|
| Control | No Intervention | Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text messages | Behavioral | Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants With Blood Pressure Control at 12 Months | Blood pressure (BP) control is defined as having BP <140/90 mmHg. | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants With Blood Pressure Control at 6 Months | Blood pressure (BP) control is defined as having BP <140/90 mmHg. | 6 months |
| Total Number of Participants With Blood Pressure Control at 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Study Participation Rate | Proportion of those invited to participate who consent and are randomized. | 2 weeks |
| Study Completion Rate | Proportion of those randomized who completed follow up at month 6. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Shea, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34382648 | Derived | Shea S, Thompson JLP, Schwartz JE, Chen Y, de Ferrante M, Vanderbeek AM, Buchsbaum R, Vargas C, Siddiqui KM, Moran AE, Stockwell M. The Retail Outlet Health Kiosk Hypertension Trial (ROKHYT): Pilot Results. Am J Hypertens. 2022 Jan 5;35(1):103-110. doi: 10.1093/ajh/hpab129. | |
| 33769555 | Derived | Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. |
| FG001 | Control | Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only the randomized participants are counted in this analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Participants With Blood Pressure Control at 12 Months | Blood pressure (BP) control is defined as having BP <140/90 mmHg. | Only includes individuals who completed the study at 12 months. | Posted | Count of Participants | Participants | 12 months after randomization |
|
Up to 12 months from Baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Shea, MD | Columbia University | 212-305-6355 | ss35@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2019 | Nov 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2019 | Dec 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood pressure (BP) control is defined as having BP <140/90 mmHg.
| 3 months |
| Mean Systolic Pressure at 12 Months | Mean systolic blood pressure measurement at 12 months from randomization. | 12 months |
| Mean Diastolic Pressure at 12 Months | Mean diastolic blood pressure measurement at 12 months from randomization. | 12 months |
| 6 months |
| Control |
Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Mean systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Mean diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages).
|
|
| Secondary | Total Number of Participants With Blood Pressure Control at 6 Months | Blood pressure (BP) control is defined as having BP <140/90 mmHg. | Only includes participants who completed the study at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Total Number of Participants With Blood Pressure Control at 3 Months | Blood pressure (BP) control is defined as having BP <140/90 mmHg. | Only includes participants who completed the study at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Mean Systolic Pressure at 12 Months | Mean systolic blood pressure measurement at 12 months from randomization. | Only includes participants who completed the study at 12 months. | Posted | Mean | Standard Deviation | mm Hg | 12 months |
|
|
|
| Other Pre-specified | Study Participation Rate | Proportion of those invited to participate who consent and are randomized. | Includes all consented individuals. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Other Pre-specified | Study Completion Rate | Proportion of those randomized who completed follow up at month 6. | Only includes randomize participants. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Mean Diastolic Pressure at 12 Months | Mean diastolic blood pressure measurement at 12 months from randomization. | Only includes individuals who completed the study at 12 months | Posted | Mean | Standard Deviation | mm Hg | 12 months |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Control | Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages). | 0 | 70 | 0 | 70 | 0 | 70 |
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