Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-01-23 @ 7:38 PM
Study NCT ID:
NCT03052959
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BETTER HEALTH: Durham
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aisha.lofters@utoronto.ca', 'phone': '4163236400', 'title': 'Dr. Aisha Lofters', 'phoneExt': '3832', 'organization': 'Unity Health Toronto'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Research coordinator administering survey to participants may have served as a co-intervention; relied exclusively on self-report; excluded non-English speakers; did not explore the role of other sociodemographic characteristics such as race/ethnicity and immigration status that may intersect with income; did not explicitly compare the clusters based on factors that may have affected uptake of recommendations, such as proximity to primary care or access to public transportation'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Immediate Intervention', 'description': "Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.", 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait List Intervention', 'description': 'Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': "Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department."}, {'id': 'OG001', 'title': 'Wait List Intervention', 'description': 'Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '23.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.', 'unitOfMeasure': 'percent of actions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Completion of Individual Actions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': "Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department."}, {'id': 'OG001', 'title': 'Wait List Intervention', 'description': 'Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.'}], 'classes': [{'title': 'Fasting blood sugar/A1C screen', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Blood pressure screen', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Blood pressure monitor', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'LDL measured', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'Breast screening', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Colorectal screening', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cervical screening', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Body mass index screening', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Waist circumference', 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Weight control', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}, {'title': 'Referral for body mass index greater than 25', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Smoking cessation', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Smoking cessation referral', 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}]}]}, {'title': 'Alcohol control', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'Alcohol cessation referral', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Physical activity improved', 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}]}]}, {'title': 'Physical activity referral', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Healthy diet score improved', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}, {'value': '91.8', 'groupId': 'OG001'}]}]}, {'title': 'Nutrition referral', 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six months', 'description': 'The investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline', 'unitOfMeasure': 'percentage of eligible actions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Self-referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Intervention', 'description': "Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department."}, {'id': 'OG001', 'title': 'Wait List Intervention', 'description': 'Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.'}], 'classes': [{'title': 'Fasting blood sugar/A1C screen', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Blood pressure screen', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Blood pressure monitored', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'LDL measured', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'Breast cancer screening', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Colorectal cancer screening', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cervical screening', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Weight control', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}, {'title': 'Referral for body mass index greater than 25', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Smoking cessation referral', 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}]}]}, {'title': 'Alcohol cessation referral', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Physical activity referral', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Nutrition referral', 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six months', 'description': 'The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.', 'unitOfMeasure': 'percentage of eligible actions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Intervention', 'description': "Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department."}, {'id': 'FG001', 'title': 'Wait List Intervention', 'description': 'Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '59'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '55'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '4'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'typeUnitsAnalyzed': 'Neighbourhoods'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Intervention', 'description': "Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department."}, {'id': 'BG001', 'title': 'Wait List Intervention', 'description': 'Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-30', 'size': 808103, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-14T16:27', 'hasProtocol': True}, {'date': '2019-07-23', 'size': 325022, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-14T16:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2017-02-10', 'resultsFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-27', 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up', 'timeFrame': 'Six months', 'description': 'The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.'}], 'secondaryOutcomes': [{'measure': 'Completion of Individual Actions', 'timeFrame': 'Six months', 'description': 'The investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline'}, {'measure': 'Number of Self-referrals', 'timeFrame': 'Six months', 'description': 'The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer and Chronic Disease Prevention']}, 'referencesModule': {'references': [{'pmid': '38575938', 'type': 'DERIVED', 'citation': "O'Brien MA, Lofters A, Wall B, Elliott R, Makuwaza T, Pietrusiak MA, Grunfeld E, Riordan B, Snider C, Pinto AD, Manca D, Sopcak N, Cornacchi SD, Huizinga J, Sivayoganathan K, Donnelly PD, Selby P, Kyle R, Rabeneck L, Baxter NN, Tinmouth J, Paszat L. Adaptation and qualitative evaluation of the BETTER intervention for chronic disease prevention and screening by public health nurses in low income neighbourhoods: views of community residents. BMC Health Serv Res. 2024 Apr 4;24(1):427. doi: 10.1186/s12913-024-10853-z."}, {'pmid': '34344340', 'type': 'DERIVED', 'citation': "Lofters AK, O'Brien MA, Sutradhar R, Pinto AD, Baxter NN, Donnelly P, Elliott R, Glazier RH, Huizinga J, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Riordan B, Selby P, Sivayoganathan K, Snider C, Sopcak N, Thorpe K, Tinmouth J, Wall B, Zuo F, Grunfeld E, Paszat L. Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial. BMC Public Health. 2021 Aug 3;21(1):1496. doi: 10.1186/s12889-021-11452-x."}, {'pmid': '28962558', 'type': 'DERIVED', 'citation': "Paszat L, Sutradhar R, O'Brien MA, Lofters A, Pinto A, Selby P, Baxter N, Donnelly PD, Elliott R, Glazier RH, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Sopcak N, Tinmouth J, Wall B, Grunfeld E. BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings. BMC Public Health. 2017 Sep 29;17(1):754. doi: 10.1186/s12889-017-4797-3."}]}, 'descriptionModule': {'briefSummary': 'The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby.\n\nObjectives:\n\n1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.\n2. Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.\n3. Share what the investigators learn with government and other public health units in Ontario and across Canada.\n\nSome clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.', 'detailedDescription': 'Research has shown that many Ontarians do not participate in all the chronic disease prevention and screening activities that could keep them healthy. Previous studies have found that a prevention practitioner, a nurse who works with health care providers and their practices, can be effective at improving the uptake of chronic disease prevention and screening activities.\n\nThe goal of this study is to adapt the BETTER intervention from a health care setting with family practice teams to a community-based strategy in designated areas in Durham Region. The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies.\n\nPrevious work by the researchers identified census dissemination areas in Ontario with: (1) the lowest quintile of median household income, (2) low cancer screening rates, and 3) poor access to primary care services. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby. The investigators will be working closely with local community agencies and primary care providers to identify people who may benefit from this study.\n\nObjectives:\n\n1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.\n2. Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.\n3. Share what the investigators learn with government and other public health units in Ontario and across Canada.\n\nSome clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. The investigators will compare the two groups. The study will involve about 120 residents in 10 designated areas. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 40 - 64 years living in sampled low income clusters in Durham region who are English speakers (including illiterate persons). Only one participant per residential household may participate.\n\nExclusion Criteria:\n\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03052959', 'briefTitle': 'BETTER HEALTH: Durham', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham', 'orgStudyIdInfo': {'id': '16-231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Intervention', 'interventionNames': ['Behavioral: Immediate Intervention']}, {'type': 'OTHER', 'label': 'Wait List Intervention', 'interventionNames': ['Other: Wait List Intervention']}], 'interventions': [{'name': 'Immediate Intervention', 'type': 'BEHAVIORAL', 'description': "The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.", 'armGroupLabels': ['Immediate Intervention']}, {'name': 'Wait List Intervention', 'type': 'OTHER', 'description': 'The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.', 'armGroupLabels': ['Wait List Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Whitby', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Durham Region Health Department', 'geoPoint': {'lat': 43.88342, 'lon': -78.93287}}], 'overallOfficials': [{'name': 'Lawrence Paszat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, {'name': 'Durham Region Health Department', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}