Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cancer
  • Chronic Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 40 years and 65 years
Gender
Both males and females

Description

While the BETTER program has been shown to successfully increase the number of preventive care and screening actions completed by patient participants after six months, it is known that it is difficult to maintain new health behaviours in the long-term. Unfortunately, it is not feasible to fund heal...

While the BETTER program has been shown to successfully increase the number of preventive care and screening actions completed by patient participants after six months, it is known that it is difficult to maintain new health behaviours in the long-term. Unfortunately, it is not feasible to fund health professionals to offer repeated follow-up visits over the time needed to turn initial behaviour changes into long-term habits. Therefore, the investigators are building upon the existing BETTER program by adding a peer health coaching extension that will provide time-limited coaching for patients who want support as they work towards achieving preventive health goals. This approach takes advantage of growing awareness of the role of lay health coaches in improving and extending the quality and value of primary care. This is a three-site, pragmatic, wait-list-controlled, randomized, Type 1 hybrid effectiveness-implementation trial with blinded outcome collection after 12 months. One site will be an urban, academic, hospital-based clinic; the second will be a clinic serving a greater proportion of patients from rural areas; and the third site will be a suburban clinic with a large South Asian population. Following receipt of the BETTER program (a single visit with a prevention practitioner), investigators will invite women who are 40-65 years old to receive behaviour change support for six months from a peer health coach (PHC). PHCs will do a 24-hr training course, which includes special techniques to support health behaviour change, before they are matched to a patient. At the suburban site, only South Asian PHCs will be recruited and this work is being guided by a South Asian Community Advisory Council made up of members of various community organizations in that region. Patients who enroll in BETTER Women will be randomized to receive peer health coaching either immediately (intervention group) or after a 12-month delay (wait-list control group). Effectiveness of the program will be assessed by evaluating for each patient, how many of a set of target chronic disease prevention and screening actions were completed at one year, in comparison to baseline. Investigators will also assess whether patients achieved the health goals that they set with their prevention practitioners, physiological markers of health, as well as habits and behaviours related to diet, physical activity, smoking and alcohol use. These outcomes will be collected via electronic surveys administered at baseline, 3-, 6-, and 12-months post enrollment as well as through extraction of data from the patients' electronic medical records and BETTER program documents. These outcomes will be compared between the two groups of patients in the study. An embedded process evaluation will be conducted during the trial to examine the implementation of the program. The process evaluation will include collection of program data, electronic surveys administered to patients as well as qualitative interviews with intervention group patients, peer health coaches and prevention practitioners. Investigators will examine how acceptable the program was to patients; whether and why any adaptations were made; how well the program was utilized; how well the PHCs delivered the intervention (e.g., what behaviour change techniques were used); how engaged patients and PHCs were with the program; and mechanism(s) of action. Ultimately, investigators expect to gain an understanding of the program's sustainability, acceptability, cost-effectiveness, and factors that might impact future attempts at spread and scale. Investigators expect to see that women in the intervention group (i.e., those who had a PHC) will complete more preventive and screening actions after one year. Investigators also expect to see that women in the intervention group will make more progress on achieving health goals and making lifestyle changes which reduce the risk of chronic diseases and cancers, that the intervention will increase women's access to resources in their primary care clinics and community, as well as improve the women's ability to maintain healthy behaviours.

Tracking Information

NCT #
NCT04746859
Collaborators
  • Canadian Cancer Society (CCS)
  • Public Health Agency of Canada (PHAC)
  • Women's College Hospital Foundation
  • Women's College Hospital Family Practice Health Centre
  • Barrie and Community Family Health Team
  • University Health Network, Toronto
  • Applied Health Research Centre
  • Summerville Family Health Team
Investigators
Principal Investigator: Noah M Ivers, MD, PhD Women's College Hospital Principal Investigator: Aisha Lofters, MD, PhD Women's College Hospital