BETTER HEALTH: Durham
Primary Purpose
Cancer and Chronic Disease Prevention
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Immediate Intervention
Wait List Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Cancer and Chronic Disease Prevention
Eligibility Criteria
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
Sites / Locations
- Durham Region Health Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate Intervention
Wait List Intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Number of Self-referrals
The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.
Full Information
NCT ID
NCT03052959
First Posted
February 10, 2017
Last Updated
October 27, 2021
Sponsor
Unity Health Toronto
Collaborators
Sunnybrook Health Sciences Centre, Durham Region Health Department, University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03052959
Brief Title
BETTER HEALTH: Durham
Official Title
Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
January 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Sunnybrook Health Sciences Centre, Durham Region Health Department, University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
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.
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:
Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer and Chronic Disease Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Title
Wait List Intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Immediate Intervention
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Wait List Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Completion of Individual Actions
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
Time Frame
Six months
Title
Number of Self-referrals
Description
The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Paszat
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Region Health Department
City
Whitby
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34344340
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. Erratum In: BMC Public Health. 2021 Sep 21;21(1):1714.
Results Reference
derived
PubMed Identifier
28962558
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.
Results Reference
derived
Learn more about this trial
BETTER HEALTH: Durham
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