Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03872856
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2019-03-07
Brief Title:
Blood Pressure-Improving Control Among Alaska Native People BP-ICAN
Sponsor:
Southcentral Foundation
Organization:
Southcentral Foundation
Study Overview
Official Title:
Home Blood Pressure Monitoring Intervention for Self-Management of High Blood Pressure Among Alaska Native People
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAR2
Brief Summary:
Blood Pressure Improving Control among Alaska Native People BP-ICAN that targets blood pressure control among Alaska Native and American Indian ANAI people diagnosed with hypertension Participants will include adults with a diagnosis of hypertension who have not achieved blood pressure control Primary Care Center PCC provider teams and associated panels of Alaska Native or American Indian ANAI adults will be randomized into the control or intervention arm The investigators will recruit up to 10 ANAI adults per PCC provider for a total of 324 participants Intervention participants will receive a home blood pressure monitor HBPM upload personal home blood pressure values into a data mall and be encouraged to communicate with providers and pharmacists about HBPM results using an online electronic health record application telephone or other existing clinical processes HBPM measurements for each intervention arm participant will be provided to provider teams and integrated pharmacists Control participants will receive care as usual Data will be collected over a 12 month period Participants will meet with investigators at time of consent baseline and 3 6 and 12 months after baseline At each visit participants will have blood pressure measured using 3 methods aneroid sphygmomanometer automated Omron upper arm cuff device and automated Omron wrist cuff device complete surveys and have height weight and arm circumference measured In-person measures are omitted during the pandemic and only one method of blood pressure measurement is used upper arm cuff device Clinical and service utilization information will be electronically queried with participant consent The investigators will examine whether participants in the intervention arm have better blood pressure control at the end of the 12 month period than participants in the control arm
Detailed Description:
Background
Cardiovascular disease CVD and stroke have become leading causes of mortality among ANAI people who experience CVD disparities in incidence risk factors and mortality especially for stroke compared to the general population From 1994-2003 stroke mortality in ANAIs was at least 25 higher than for Whites in Alaska Over the same period stroke mortality for ANAIs under age 45 increased 400 but declined in Whites In addition the decline in age-adjusted CVD mortality observed in recent decades within the general population does not extend to ANAIs Controlling hypertension is a pillar of prevention for CVD and stroke
Although ANAIs were formerly thought to have a very low prevalence of stroke and CVD more reliable newer data indicate high levels of hypertension and associated mortality A recent systematic review of 141 publications on hypertension in ANAI people documented a significant increase in recorded prevalence over the past 3 decades as well as a significantly higher prevalence in ANAI adults than in reference populations usually White Aggregated data from the Behavioral Risk Factor Surveillance System BRFSS also show a higher prevalence of self-reported hypertension in ANAIs than in non-Hispanic Whites 27 vs 22 The National Health Interview Survey found a similar disparity of 35 vs 26 in ANAIs vs Whites As in non-Hispanic Whites 61 of ANAIs with hypertension were taking anti-hypertensive medication In a previous study an investigator on the present proposal examined the health records of 524 ANAI elders finding that 23 had undiagnosed hypertension and 38 had diagnosed hypertension Of those with diagnoses 81 were taking medication 37 had well-controlled blood pressure BP and lifestyle counseling was rare
Ongoing management of high BP often requires healthcare providers to initiate or intensify therapy in response to uncontrolled high BP A recent review concluded that the patientprovider relationship patientprovider communication and patient-centered decision making were essential to appropriate decisions on medication change Another study using electronic health record EHR data on military veterans found that 60 of patients with hypertension had poorly controlled systolic BP yet less than half of clinicians made medication changes after a computer-generated notification
Improving BP control requires the involvement not only of individuals but of healthcare systems and social environments Communications must extend care to patients where patients are outside the clinic facilitate BP self-management and minimize barriers to care ANAIs face in healthcare access Across Alaska 60 of residents are medically underserved and in 75 of Alaskan communities regardless of residents race comprehensive healthcare services are accessible only by air or water Even in urban areas health disparities among ANAIs persist and access to care is affected by factors such as lack of transportation
CVD morbidity mortality and organ damage are more accurately predicted by home blood pressure monitoring HBPM than by in-office measurements HBPM avoids over-treating sporadic high BP readings and white coat hypertension while facilitating control of both resistant and masked hypertension high at home and normal in the clinic which are associated with stroke Compared to usual care or HBPM alone HBPM combined with self-titration of medications or with physician pharmacist or nurse management leads to better use of medications and BP control Research shows the value of using HBPM values to trigger modifications in anti-hypertensive regimens and the addition of provider feedback patient and provider education and decision-making support to encourage treatment adjustments improves control even more HBPM can support patient decision making provide data to providers facilitate patientprovider communication and engage educate and empower patients HBPM devices are widely accepted by patients who prefer them to clinic-based measurements HBPM interventions appear to be most effective in patients with less well-controlled BP at baseline Therefore tailored HBPM interventions have been developed for minorities who may receive more benefit from HBPM than Whites
Significance
BP-ICAN is innovative in many ways First it will be the only rigorous population-based study about BP control for prevention of CVD and stroke in ANs and one of very few multilevel interventions in any minority population Second the Southcentral Foundation SCF service area includes rural suburban and urban locations Third the intervention design addresses therapeutic inertia a well-recognized barrier to hypertension control that is often neglected in clinical trials so the approach to improve self-efficacy and ownership should lead to more timely communication with providers and titration of medications
The investigators will conduct a group-randomized trial for improving BP control among ANAI adults with diagnosed hypertension Study group assignment will occur by randomizing all SCF primary care panels to the BP-ICAN or usual care control arms adults with uncontrolled hypertension will be nested within groups defined by panel which corresponds to one provider For each panel investigators will recruit up to 10 ANAI adults expecting average of 8-9 per provider for a total n 324 who have had systolic BP 130 mmHg measured at one or more clinic visits in the past 18 months OR who have previously diagnosed hypertension and systolic BP 130 mmHg measured at the study screening or home screening visit The study period for all participants will last 12 months
Participants who are randomized to the BP-ICAN arm will receive education about BP control CVD and stroke and the importance of hypertension management for prevention other lifestyle changes that can prevent or reduce morbidity from hypertension and educational materials about the importance of timely response to uncontrolled hypertension BP-ICAN arm participants will also receive HBPM equipment Omron device and training in its use interpretation of results and assistance with communicating high BP values to healthcare providers Lastly participants will receive culturally tailored text messages to reinforce the educational material and motivate adherence to HBPM and provider communication strategies Participants whose providers have been randomized to the control condition will continue to receive care as usual
Patient-initiated communication about uncontrolled BP will serve as one component of the provider-level intervention Participants will be trained to sync HBPM and smart phone to automatically upload BP measurements into a data repository using Omrons free wellness application This will update the participants data on Omrons Wellness Application website Investigators plan to use a cloud-based technology platform to serve as a data repository and are working with tribal leadership institutional privacy officers compliance officers and providers on how data will displayed and stored within the health care system The goal is to make aggregate BP measure data available to providers in either a personal health record PHR andor health information exchange HIE that allows for transmission of select measures into the electronic health and or population health record Note that this protocol was developed based on extensive collaboration with SCF providers
At the individual level the primary outcome is within-person change in systolic BP Secondary outcomes are diastolic BP anti-hypertensive medication use and adherence physical activity weight and tobacco use Individual-level outcomes will be measured at baseline 3 months 6 months and 1 year post-baseline At the provider level the primary outcome is change in prescribing behavior for medication and other relevant lifestyle changes At the systems level the primary outcome is change in systolic BP for all adults with hypertension whose providers are randomized to the BP-ICAN arm vs the care as usual arm regardless of whether the adults were directly enrolled into the study
Cardiovascular disease CVD and stroke have become leading causes of mortality among ANAI people who experience CVD disparities in incidence risk factors and mortality especially for stroke compared to the general population From 1994-2003 stroke mortality in ANAIs was at least 25 higher than for Whites in Alaska Over the same period stroke mortality for ANAIs under age 45 increased 400 but declined in Whites In addition the decline in age-adjusted CVD mortality observed in recent decades within the general population does not extend to ANAIs Controlling hypertension is a pillar of prevention for CVD and stroke
Although ANAIs were formerly thought to have a very low prevalence of stroke and CVD more reliable newer data indicate high levels of hypertension and associated mortality A recent systematic review of 141 publications on hypertension in ANAI people documented a significant increase in recorded prevalence over the past 3 decades as well as a significantly higher prevalence in ANAI adults than in reference populations usually White Aggregated data from the Behavioral Risk Factor Surveillance System BRFSS also show a higher prevalence of self-reported hypertension in ANAIs than in non-Hispanic Whites 27 vs 22 The National Health Interview Survey found a similar disparity of 35 vs 26 in ANAIs vs Whites As in non-Hispanic Whites 61 of ANAIs with hypertension were taking anti-hypertensive medication In a previous study an investigator on the present proposal examined the health records of 524 ANAI elders finding that 23 had undiagnosed hypertension and 38 had diagnosed hypertension Of those with diagnoses 81 were taking medication 37 had well-controlled blood pressure BP and lifestyle counseling was rare
Ongoing management of high BP often requires healthcare providers to initiate or intensify therapy in response to uncontrolled high BP A recent review concluded that the patientprovider relationship patientprovider communication and patient-centered decision making were essential to appropriate decisions on medication change Another study using electronic health record EHR data on military veterans found that 60 of patients with hypertension had poorly controlled systolic BP yet less than half of clinicians made medication changes after a computer-generated notification
Improving BP control requires the involvement not only of individuals but of healthcare systems and social environments Communications must extend care to patients where patients are outside the clinic facilitate BP self-management and minimize barriers to care ANAIs face in healthcare access Across Alaska 60 of residents are medically underserved and in 75 of Alaskan communities regardless of residents race comprehensive healthcare services are accessible only by air or water Even in urban areas health disparities among ANAIs persist and access to care is affected by factors such as lack of transportation
CVD morbidity mortality and organ damage are more accurately predicted by home blood pressure monitoring HBPM than by in-office measurements HBPM avoids over-treating sporadic high BP readings and white coat hypertension while facilitating control of both resistant and masked hypertension high at home and normal in the clinic which are associated with stroke Compared to usual care or HBPM alone HBPM combined with self-titration of medications or with physician pharmacist or nurse management leads to better use of medications and BP control Research shows the value of using HBPM values to trigger modifications in anti-hypertensive regimens and the addition of provider feedback patient and provider education and decision-making support to encourage treatment adjustments improves control even more HBPM can support patient decision making provide data to providers facilitate patientprovider communication and engage educate and empower patients HBPM devices are widely accepted by patients who prefer them to clinic-based measurements HBPM interventions appear to be most effective in patients with less well-controlled BP at baseline Therefore tailored HBPM interventions have been developed for minorities who may receive more benefit from HBPM than Whites
Significance
BP-ICAN is innovative in many ways First it will be the only rigorous population-based study about BP control for prevention of CVD and stroke in ANs and one of very few multilevel interventions in any minority population Second the Southcentral Foundation SCF service area includes rural suburban and urban locations Third the intervention design addresses therapeutic inertia a well-recognized barrier to hypertension control that is often neglected in clinical trials so the approach to improve self-efficacy and ownership should lead to more timely communication with providers and titration of medications
The investigators will conduct a group-randomized trial for improving BP control among ANAI adults with diagnosed hypertension Study group assignment will occur by randomizing all SCF primary care panels to the BP-ICAN or usual care control arms adults with uncontrolled hypertension will be nested within groups defined by panel which corresponds to one provider For each panel investigators will recruit up to 10 ANAI adults expecting average of 8-9 per provider for a total n 324 who have had systolic BP 130 mmHg measured at one or more clinic visits in the past 18 months OR who have previously diagnosed hypertension and systolic BP 130 mmHg measured at the study screening or home screening visit The study period for all participants will last 12 months
Participants who are randomized to the BP-ICAN arm will receive education about BP control CVD and stroke and the importance of hypertension management for prevention other lifestyle changes that can prevent or reduce morbidity from hypertension and educational materials about the importance of timely response to uncontrolled hypertension BP-ICAN arm participants will also receive HBPM equipment Omron device and training in its use interpretation of results and assistance with communicating high BP values to healthcare providers Lastly participants will receive culturally tailored text messages to reinforce the educational material and motivate adherence to HBPM and provider communication strategies Participants whose providers have been randomized to the control condition will continue to receive care as usual
Patient-initiated communication about uncontrolled BP will serve as one component of the provider-level intervention Participants will be trained to sync HBPM and smart phone to automatically upload BP measurements into a data repository using Omrons free wellness application This will update the participants data on Omrons Wellness Application website Investigators plan to use a cloud-based technology platform to serve as a data repository and are working with tribal leadership institutional privacy officers compliance officers and providers on how data will displayed and stored within the health care system The goal is to make aggregate BP measure data available to providers in either a personal health record PHR andor health information exchange HIE that allows for transmission of select measures into the electronic health and or population health record Note that this protocol was developed based on extensive collaboration with SCF providers
At the individual level the primary outcome is within-person change in systolic BP Secondary outcomes are diastolic BP anti-hypertensive medication use and adherence physical activity weight and tobacco use Individual-level outcomes will be measured at baseline 3 months 6 months and 1 year post-baseline At the provider level the primary outcome is change in prescribing behavior for medication and other relevant lifestyle changes At the systems level the primary outcome is change in systolic BP for all adults with hypertension whose providers are randomized to the BP-ICAN arm vs the care as usual arm regardless of whether the adults were directly enrolled into the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-08-038 | OTHER | Alaska Area Institutional Review Board | None |