Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-08 @ 5:55 AM
Study NCT ID:
NCT03974334
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paula.gardiner@umassmed.edu', 'phone': '7744416716', 'title': 'Dr. Paula Gardiner', 'organization': 'University of Massachusetts Medical School'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This feasibility study tested the OWL platform with hypertension patients in a regional medical center. Despite finding outcome improvements in lifestyle and self-management of HTN, a larger RCT is needed to assess for significant changes.'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Any adverse event occurrences were captured through regular study staff and participants communications, as well as through provider/participant one-on-ones at the medical group visits held at Week 4 and 8 of the 8 week study.', 'eventGroups': [{'id': 'EG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two cohorts of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Pressure Knowledge Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.13', 'spread': '1.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 Week', 'description': "The Blood Pressure Knowledge Questionnaire (BPKQ) was used to assess the participants' level of knowledge regarding common characteristics and risk factors of hypertension. It consists of 8 items covering topics like common symptoms, White Coat Syndrome, and the amount of salt consumed by the average American, with a mix of multiple choice (6 items) and true/false questions (2 items). The correct items are totaled, with a range of 1-8, and higher scores indicating more hypertension knowledge. The information needed to answer each item correctly was covered in OWL-H's curriculum.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hypertension Self-Care Profile Self-Efficacy Instrument', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.54', 'spread': '7.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "The self-efficacy instrument of the Hypertension Self-care Profile (HTN-SCP-SE) used for this study consists of 20 items assessing the respondent's confidence on a scale of 1 (Not confident) to 4 (Very confident) to regularly engage in lifestyle habits that are recommended for patients with high blood pressure. It was developed and validated in 2014. The instrument results in a total confidence/self-efficacy score ranging from 20-80, with higher scores indicating higher levels of confidence in engaging in heart-healthy lifestyle habits.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mediterranean Diet Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '1.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 Weeks', 'description': 'The Mediterranean Diet Questionnaire (MDQ) consists of 14 yes-no items that assess participant\'s consumption of heart protective or harming foods. It was originally developed in Spain in 2004 to briefly assess adherence to a Mediterranean Diet and has been validated in multiple studies. Items assess the type of food eaten and whether the appropriate serving size is consumed, on a weekly basis. "Yes" responses are totaled, resulting in a score ranging from 0-14, with higher scores indicating a higher adherence to the Mediterranean Diet.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not fully complete this questionnaire at baseline, resulting in 23 rather than 24 participants assessed.'}, {'type': 'SECONDARY', 'title': 'Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '1.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'To assess blood pressure self-monitoring pre-post, we first asked "Are you regularly (at least once per week) able to measure your blood pressure outside of your doctor appointments?". Those who said "yes" were then asked "How often, in a regular week, do you measure your blood pressure outside of your doctor appointments?" In their post-surveys, they were again asked to estimate their average weekly number of entries. Along with these self-report numbers, the OWL-H platform also keeps a log of every blood pressure entered by each participant across the 8 weeks.', 'unitOfMeasure': 'measurement per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant never entered a blood pressure reading in OWL-H.'}, {'type': 'SECONDARY', 'title': 'Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.74', 'spread': '2.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 Weeks', 'description': 'Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks.', 'unitOfMeasure': 'Measurements per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant never entered a blood pressure reading in OWL-H.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from July-October of 2019 from Worcester, MA area adult primary care clinics, and either self-referred (via flyers and brochures placed around the clinics) or were referred by their primary care providers.They were then screened for eligibility, including a current diagnosis of hypertension in their EMR, and consented.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of thirteen participants will use the Our Whole Lives - Hypertension eHealth online tool for 8 weeks each, with baseline, midline, and follow-up data collected to determine any change due to the intervention.\n\nOWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Blood Pressure Knowledge Questionnaire', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.58', 'spread': '1.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Blood Pressure Knowledge Questionnaire (BPKQ) was used to assess the participants' level of knowledge regarding common characteristics and risk factors of hypertension. It consists of 8 items covering topics like common symptoms, White Coat Syndrome, and the amount of salt consumed by the average American, with a mix of multiple choice (6 items) and true/false questions (2 items). The correct items are totaled, with a range of 1-8, and higher scores indicating more hypertension knowledge. The information needed to answer each item correctly was covered in OWL-H's curriculum.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypertension Self-Care Profile Self-Efficacy Instrument', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.67', 'spread': '9.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The self-efficacy instrument of the Hypertension Self-care Profile (HTN-SCP-SE) used for this study consists of 20 items assessing the respondent's confidence on a scale of 1 (Not confident) to 4 (Very confident) to regularly engage in lifestyle habits that are recommended for patients with high blood pressure. It was developed and validated in 2014. The instrument results in a total confidence/self-efficacy score ranging from 20-80, with higher scores indicating higher levels of confidence in engaging in heart-healthy lifestyle habits.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mediterranean Diet Questionnaire', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.65', 'spread': '2.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Mediterranean Diet Questionnaire (MDQ) consists of 14 yes-no items that assess participant\'s consumption of heart protective or harming foods. It was originally developed in Spain in 2004 to briefly assess adherence to a Mediterranean Diet and has been validated in multiple studies. Items assess the type of food eaten and whether the appropriate serving size is consumed, on a weekly basis. "Yes" responses are totaled, resulting in a score ranging from 0-14, with higher scores indicating a higher adherence to the Mediterranean Diet.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant did not fully complete this questionnaire at baseline, resulting in 23 rather than 24 participants assessed.'}, {'title': 'Blood Pressure Self-Monitoring (Self-Reported)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'To assess blood pressure self-monitoring pre-post, we first asked "Are you regularly (at least once per week) able to measure your blood pressure outside of your doctor appointments?". Those who said "yes" were then asked "How often, in a regular week, do you measure your blood pressure outside of your doctor appointments?" In their post-surveys, they were again asked to estimate their average weekly number of entries. Along with these self-report numbers, the OWL-H platform also keeps a log of every blood pressure entered by each participant across the 8 weeks.', 'unitOfMeasure': 'Measurements/week', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 10 participants reported the ability to perform home self-monitoring of their blood pressure at Baseline.'}], 'populationDescription': 'One participant was lost to follow-up prior to Baseline data collection.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 289036, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-03T13:20', 'hasProtocol': True}, {'date': '2020-08-14', 'size': 135353, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-03T13:21', 'hasProtocol': False}, {'date': '2020-08-14', 'size': 268887, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-03T13:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'There are 2 cohorts taking part in the same intervention at 2 separate times.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2019-05-29', 'resultsFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-05', 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Knowledge Questionnaire', 'timeFrame': '8 Week', 'description': "The Blood Pressure Knowledge Questionnaire (BPKQ) was used to assess the participants' level of knowledge regarding common characteristics and risk factors of hypertension. It consists of 8 items covering topics like common symptoms, White Coat Syndrome, and the amount of salt consumed by the average American, with a mix of multiple choice (6 items) and true/false questions (2 items). The correct items are totaled, with a range of 1-8, and higher scores indicating more hypertension knowledge. The information needed to answer each item correctly was covered in OWL-H's curriculum."}, {'measure': 'Hypertension Self-Care Profile Self-Efficacy Instrument', 'timeFrame': '8 weeks', 'description': "The self-efficacy instrument of the Hypertension Self-care Profile (HTN-SCP-SE) used for this study consists of 20 items assessing the respondent's confidence on a scale of 1 (Not confident) to 4 (Very confident) to regularly engage in lifestyle habits that are recommended for patients with high blood pressure. It was developed and validated in 2014. The instrument results in a total confidence/self-efficacy score ranging from 20-80, with higher scores indicating higher levels of confidence in engaging in heart-healthy lifestyle habits."}, {'measure': 'Mediterranean Diet Questionnaire', 'timeFrame': '8 Weeks', 'description': 'The Mediterranean Diet Questionnaire (MDQ) consists of 14 yes-no items that assess participant\'s consumption of heart protective or harming foods. It was originally developed in Spain in 2004 to briefly assess adherence to a Mediterranean Diet and has been validated in multiple studies. Items assess the type of food eaten and whether the appropriate serving size is consumed, on a weekly basis. "Yes" responses are totaled, resulting in a score ranging from 0-14, with higher scores indicating a higher adherence to the Mediterranean Diet.'}], 'secondaryOutcomes': [{'measure': 'Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week', 'timeFrame': '8 weeks', 'description': 'To assess blood pressure self-monitoring pre-post, we first asked "Are you regularly (at least once per week) able to measure your blood pressure outside of your doctor appointments?". Those who said "yes" were then asked "How often, in a regular week, do you measure your blood pressure outside of your doctor appointments?" In their post-surveys, they were again asked to estimate their average weekly number of entries. Along with these self-report numbers, the OWL-H platform also keeps a log of every blood pressure entered by each participant across the 8 weeks.'}, {'measure': 'Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week', 'timeFrame': '8 Weeks', 'description': 'Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Pressure, High'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '26824963', 'type': 'BACKGROUND', 'citation': 'Bartolome RE, Chen A, Handler J, Platt ST, Gould B. Population Care Management and Team-Based Approach to Reduce Racial Disparities among African Americans/Blacks with Hypertension. Perm J. 2016 Winter;20(1):53-9. doi: 10.7812/TPP/15-052.'}, {'pmid': '24847953', 'type': 'BACKGROUND', 'citation': 'Fang J, Yang Q, Ayala C, Loustalot F. Disparities in access to care among US adults with self-reported hypertension. Am J Hypertens. 2014 Nov;27(11):1377-86. doi: 10.1093/ajh/hpu061. Epub 2014 May 21.'}, {'pmid': '25105072', 'type': 'BACKGROUND', 'citation': 'Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.'}, {'pmid': '27979754', 'type': 'BACKGROUND', 'citation': 'Gardiner P, Lestoquoy AS, Gergen-Barnett K, Penti B, White LF, Saper R, Fredman L, Stillman S, Lily Negash N, Adelstein P, Brackup I, Farrell-Riley C, Kabbara K, Laird L, Mitchell S, Bickmore T, Shamekhi A, Liebschutz JM. Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression. Contemp Clin Trials. 2017 Mar;54:25-35. doi: 10.1016/j.cct.2016.12.013. Epub 2016 Dec 13.'}, {'pmid': '35576575', 'type': 'DERIVED', 'citation': 'Gardiner P, McGonigal L, Villa A, Kovell LC, Rohela P, Cauley A, Rinker D, Olendzki B. Our Whole Lives for Hypertension and Cardiac Risk Factors-Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial. JMIR Form Res. 2022 May 16;6(5):e29227. doi: 10.2196/29227.'}, {'pmid': '34357790', 'type': 'DERIVED', 'citation': 'Rohela P, Olendzki B, McGonigal LJ, Villa A, Gardiner P. A Teaching Kitchen Medical Groups Visit with an eHealth Platform for Hypertension and Cardiac Risk Factors: A Qualitative Feasibility Study. J Altern Complement Med. 2021 Nov;27(11):974-983. doi: 10.1089/acm.2021.0148. Epub 2021 Aug 5.'}]}, 'descriptionModule': {'briefSummary': "This is a one-year study. The study's primary outcome is successful improvement of the Our Whole Lives for Hypertension (OWL-H) online patient education platform, based upon participant use and focus group feedback, to deliver information on self-management of hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure.\n\nSpecific Aim 1 - To pilot test the OWL-H platform for 8 weeks with 26 patients with hypertension (2 groups of 13) to refine its utility for home self-monitoring (number of times patients record home blood pressure and input this data onto OWL-H and engagement of self-management (i.e. # of logins, # of mind body sessions completed, # of times modules accessed each day)). Hypothesis 1: Eighty percent of patients will log in and record their blood pressures.\n\nSpecific Aim 2 - At the end of each group, hold a focus group to obtain information about: 1) the barriers and facilitators of using the OWL-H platform and using OWL-H to self-monitor blood pressure at home, 2) satisfaction with OWL-H, 3) how OWL-H helped with reduction of number of cardiac risk factors (e.g., smoking, eating habits, perceived stress, and amount of exercise and health-related quality of life).", 'detailedDescription': "This is a one-year pre post clinical study. The study's primary outcome is successful improvement of the Our Whole Lives for Hypertension (OWL-H) online patient education platform, based upon participant use and focus group feedback, to deliver information on self-management of hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure. We piloted online OWL-H platform for 8 weeks with 26 patients with hypertension to refine its utility for home self-monitoring. We also held a focus group to obtain information about: 1) the barriers and facilitators of using the OWL-H platform and using OWL-H to self-monitor blood pressure at home, 2) satisfaction with OWL-H, 3) how OWL-H helped with reduction of number of cardiac risk factors"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects of all races and ethnicities who are English-speaking adults over the age of 18 and who have a current diagnosis of hypertension.. OWL in currently only available in English.\n* Subjects' physical and mental health status will be sufficient to be able to comprehend instructions and participate in the interventions.\n* Subjects must be able to access computer technology (cellular phone, desktop, laptop) and the internet to utilize the online OWL-H.\n\nExclusion Criteria:\n\n* Serious underlying systemic or co-morbid disease, including psychotic or manic symptoms, which preclude physical or cognitive ability to participate in the intervention.\n\nThe risk-benefit ratio of the interventions for these individuals may be potentially higher than acceptable.\n\n* Active substance abuse, given that individuals who have active substance abuse pose a higher risk both to themselves and other members of the groups.\n* Beginning new hypertension treatments in the past week or planning to begin new hypertension treatments in the next few weeks, or planning a major medical event in the next few weeks, which would interfere with accurately determining the effect of the intervention on impact in this study.\n* Subjects who are pregnant will be not included in this study given that the risk-benefit ratio of this intervention may be higher than acceptable for these individuals due to the potential onset of non-study related gestational diabetes and/or gestational hypertension. Determination of pregnancy status will be based upon subject self-report.\n* Subjects who are not willing to participate in the intervention or attend the group visits."}, 'identificationModule': {'nctId': 'NCT03974334', 'acronym': 'OWL-H', 'briefTitle': 'Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool', 'orgStudyIdInfo': {'id': 'H00015619'}, 'secondaryIdInfos': [{'id': '5U54HL143541-03', 'link': 'https://reporter.nih.gov/quickSearch/5U54HL143541-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OWL-Hypertension 8 Wk Trial', 'description': 'Two groups of thirteen participants will use the Our Whole Lives - Hypertension eHealth online tool for 8 weeks each, with baseline, midline, and follow-up data collected to determine any change due to the intervention.', 'interventionNames': ['Behavioral: OWL-Hypertension 8 Wk Trial']}], 'interventions': [{'name': 'OWL-Hypertension 8 Wk Trial', 'type': 'BEHAVIORAL', 'otherNames': ['Our Whole Lives - Hypertension'], 'description': 'Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.', 'armGroupLabels': ['OWL-Hypertension 8 Wk Trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Paula Gardiner, Associate Professor, Associate Research Director, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data being collected is based on an intervention that is changing from cohort focus group to cohort focus group. It is also small sample size (n = 26) and only pilot data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paula Gardiner', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Associate Research Director, Medical Group Visit Program Director', 'investigatorFullName': 'Paula Gardiner', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}