BETTER HEALTH: Durham

NCT03052959 | Completed Results

• 1 other identifier: 16-231
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer and Chronic Disease Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Completion of Individual Actions

  Six months

• Number of Self-referrals

  Six months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Behavioral: Immediate Intervention

Wait List Intervention

OTHER

Other: Wait List Intervention

Interventions

Immediate Intervention BEHAVIORAL

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.

Immediate Intervention

Wait List Intervention OTHER

The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.

Wait List Intervention

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Unity Health Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Durham Region Health Department: collaborator
• University of Toronto: collaborator

Study Sites (1)

Durham Region Health Department

Whitby, Ontario, Canada

Location

Related Publications (3)

• 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: 38575938 DERIVED

• 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: 34344340 DERIVED

• 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.

  PMID: 28962558 DERIVED

MeSH Terms

Conditions

Neoplasms

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Aisha Lofters
• Organization: Unity Health Toronto

aisha.lofters@utoronto.ca

4163236400

Study Officials

• Lawrence Paszat

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: October 2, 2017
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)