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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03052959
Other study ID # 16-231
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2017
Est. completion date January 28, 2020

Study information

Verified date October 2021
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date January 28, 2020
Est. primary completion date January 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
Canada Durham Region Health Department Whitby Ontario

Sponsors (4)

Lead Sponsor Collaborator
Unity Health Toronto Durham Region Health Department, Sunnybrook Health Sciences Centre, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
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. Six months
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 Six months
Secondary Number of Self-referrals The investigators will report the frequency with which self-referrals were reported to the prevention practitioner. Six months