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BETTER HEALTH: Durham

Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03052959
Enrollment
126
Registered
2017-02-14
Start date
2017-10-02
Completion date
2020-01-28
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer and Chronic Disease Prevention

Brief summary

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. Objectives: 1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities. 2. 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. 3. Share what the investigators learn with government and other public health units in Ontario and across Canada. Some 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.

Detailed description

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. The 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. Previous 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. Objectives: 1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities. 2. 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. 3. Share what the investigators learn with government and other public health units in Ontario and across Canada. Some 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.

Interventions

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.

OTHERWait 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.

Sponsors

Sunnybrook Health Sciences Centre
CollaboratorOTHER
Durham Region Health Department
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-upSix monthsThe 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.

Secondary

MeasureTime frameDescription
Completion of Individual ActionsSix monthsThe investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline
Number of Self-referralsSix monthsThe investigators will report the frequency with which self-referrals were reported to the prevention practitioner.

Countries

Canada

Participant flow

Participants by arm

ArmCount
Immediate Intervention
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.
59
Wait List Intervention
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
66
Total125

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up45

Baseline characteristics

CharacteristicImmediate InterventionWait List InterventionTotal
Age, Continuous54.5 years
STANDARD_DEVIATION 6.4
53.2 years
STANDARD_DEVIATION 6.6
53.8 years
STANDARD_DEVIATION 6.5
Race/Ethnicity, Customized
Race/ethnicity
Other
9 Participants14 Participants23 Participants
Race/Ethnicity, Customized
Race/ethnicity
White
50 Participants52 Participants102 Participants
Sex: Female, Male
Female
21 Participants32 Participants53 Participants
Sex: Female, Male
Male
38 Participants34 Participants72 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 590 / 66
other
Total, other adverse events
0 / 590 / 66
serious
Total, serious adverse events
0 / 590 / 66

Outcome results

Primary

Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up

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.

Time frame: Six months

ArmMeasureValue (MEAN)Dispersion
Immediate InterventionComposite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up64.5 percent of actionsStandard Deviation 27.5
Wait List InterventionComposite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up42.1 percent of actionsStandard Deviation 23.8
Secondary

Completion of Individual Actions

The investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline

Time frame: Six months

ArmMeasureGroupValue (NUMBER)
Immediate InterventionCompletion of Individual ActionsWaist circumference73.6 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsLDL measured31.6 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsWeight control53.8 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsHealthy diet score improved90.4 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsReferral for body mass index greater than 2576.9 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsBreast screening50 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsSmoking cessation11.1 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsBlood pressure screen81.8 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsSmoking cessation referral59.3 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsColorectal screening14.3 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsAlcohol control66.7 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsPhysical activity referral71.1 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsAlcohol cessation referral40 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsCervical screening25 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsPhysical activity improved62.2 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsBlood pressure monitor66.7 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsBody mass index screening72.7 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsNutrition referral67.3 percentage of eligible actions
Immediate InterventionCompletion of Individual ActionsFasting blood sugar/A1C screen29.0 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsNutrition referral29.5 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsFasting blood sugar/A1C screen25.0 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsBlood pressure screen41.7 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsBlood pressure monitor66.7 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsLDL measured26.3 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsBreast screening0 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsColorectal screening0 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsCervical screening11.1 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsBody mass index screening0 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsWaist circumference1.6 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsWeight control57.1 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsReferral for body mass index greater than 2546.9 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsSmoking cessation3.6 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsSmoking cessation referral32.1 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsAlcohol control52.4 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsAlcohol cessation referral9.5 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsPhysical activity improved64.3 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsHealthy diet score improved91.8 percentage of eligible actions
Wait List InterventionCompletion of Individual ActionsPhysical activity referral41.1 percentage of eligible actions
Secondary

Number of Self-referrals

The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.

Time frame: Six months

ArmMeasureGroupValue (NUMBER)
Immediate InterventionNumber of Self-referralsBlood pressure monitored66.7 percentage of eligible actions
Immediate InterventionNumber of Self-referralsReferral for body mass index greater than 2576.9 percentage of eligible actions
Immediate InterventionNumber of Self-referralsBreast cancer screening50 percentage of eligible actions
Immediate InterventionNumber of Self-referralsSmoking cessation referral59.3 percentage of eligible actions
Immediate InterventionNumber of Self-referralsBlood pressure screen81.8 percentage of eligible actions
Immediate InterventionNumber of Self-referralsAlcohol cessation referral40 percentage of eligible actions
Immediate InterventionNumber of Self-referralsColorectal cancer screening14.3 percentage of eligible actions
Immediate InterventionNumber of Self-referralsPhysical activity referral71.1 percentage of eligible actions
Immediate InterventionNumber of Self-referralsLDL measured31.6 percentage of eligible actions
Immediate InterventionNumber of Self-referralsNutrition referral67.3 percentage of eligible actions
Immediate InterventionNumber of Self-referralsWeight control53.8 percentage of eligible actions
Immediate InterventionNumber of Self-referralsCervical screening25.0 percentage of eligible actions
Immediate InterventionNumber of Self-referralsFasting blood sugar/A1C screen29.0 percentage of eligible actions
Wait List InterventionNumber of Self-referralsCervical screening11.1 percentage of eligible actions
Wait List InterventionNumber of Self-referralsFasting blood sugar/A1C screen25.0 percentage of eligible actions
Wait List InterventionNumber of Self-referralsBlood pressure screen41.7 percentage of eligible actions
Wait List InterventionNumber of Self-referralsBlood pressure monitored66.7 percentage of eligible actions
Wait List InterventionNumber of Self-referralsLDL measured26.3 percentage of eligible actions
Wait List InterventionNumber of Self-referralsBreast cancer screening0 percentage of eligible actions
Wait List InterventionNumber of Self-referralsColorectal cancer screening0 percentage of eligible actions
Wait List InterventionNumber of Self-referralsWeight control57.1 percentage of eligible actions
Wait List InterventionNumber of Self-referralsReferral for body mass index greater than 2546.9 percentage of eligible actions
Wait List InterventionNumber of Self-referralsSmoking cessation referral32.1 percentage of eligible actions
Wait List InterventionNumber of Self-referralsAlcohol cessation referral9.5 percentage of eligible actions
Wait List InterventionNumber of Self-referralsPhysical activity referral41.1 percentage of eligible actions
Wait List InterventionNumber of Self-referralsNutrition referral29.5 percentage of eligible actions

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026