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BETTER HEALTH: Durham

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052959
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Durham Region Health Department
University of Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment Phase
Cancer and Chronic Disease Prevention Behavioral: Immediate Intervention Other: Wait List Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : January 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Intervention Behavioral: 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.

Wait List Intervention Other: 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.




Primary Outcome Measures :
  1. Composite outcome measure: ratio of the number of eligible CDPS actions at baseline that are subsequently met at follow-up [ Time Frame: Six months ]
    The primary outcome measure is a composite index, expressed as the ratio (multiplied by 100) of the number of eligible CDPS actions at baseline (denominator) that are subsequently met (by self-report) at follow-up (numerator), 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 :
  1. Completion of individual actions [ Time Frame: Six months ]
    The investigators will report the frequency with which individual CDPS actions were completed.

  2. Number of self-referrals [ Time Frame: Six months ]
    The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052959


Locations
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Canada, Ontario
Durham Region Health Department
Whitby, Ontario, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Durham Region Health Department
University of Toronto
Investigators
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Principal Investigator: Lawrence Paszat Sunnybrook Health Sciences Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03052959    
Other Study ID Numbers: 16-231
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes