Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program
NCT ID: NCT04746859
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
268 participants
INTERVENTIONAL
2021-06-14
2025-04-30
Brief Summary
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Detailed Description
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This is a three-site, pragmatic, wait-list-controlled, randomized, Type 1 hybrid effectiveness-implementation trial with blinded outcome collection after 6 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. Investigators will invite women who are 40-68 years old to have a single visit with a prevention practitioner and receive behaviour change support for up to six months from a health coach. Coaches 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 peer health coaches 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 health coaching either immediately (intervention group) or after a 6-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 six months, 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- and 6-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. Additionally, investigators will survey intervention group participants and extract relevant data from their electronic medical records at 12-months\* post enrollment.
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 coaches delivered the intervention (e.g., what behaviour change techniques were used); how engaged patients and coaches 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 health coach) will complete more preventive and screening actions after six months. 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.
Note\*: The investigators initially planned to collect surveys and data for the primary outcome (for both groups) at 12 months post enrollment. However, due to pandemic-related recruitment challenges, the data collection timeline was amended as described above to allow more time for recruitment within the project timeline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention
Patients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training), complete the baseline survey then be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer. Patients will be administered additional surveys at 3 and 6 months and a final survey at 12 months.
Prevention Visit
Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.
Peer health coaching
Patients will be invited to register with the software platform used to facilitate peer health coaching. Once they have registered, they will be matched to a peer health coach who will connect with the patient to initiate the process. The coach will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that were developed with their prevention practitioner. The coach's approach will be informed by principles of brief action planning and motivational interviewing. Coaches will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring. Coaching will occur over 12-16 sessions via phone calls, text messages, video calls and/or in-person meetings as desired/convenient and in accordance with local public health guidelines.
Wait-list Control
Patients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training) and complete a baseline survey, after which they will receive usual care from their healthcare providers. Patients will be administered another survey at 3 months and a final survey at 6 months. After study completion (about 6-months after the initial prevention visit), patients will be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer.
Prevention Visit
Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.
Interventions
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Prevention Visit
Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.
Peer health coaching
Patients will be invited to register with the software platform used to facilitate peer health coaching. Once they have registered, they will be matched to a peer health coach who will connect with the patient to initiate the process. The coach will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that were developed with their prevention practitioner. The coach's approach will be informed by principles of brief action planning and motivational interviewing. Coaches will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring. Coaching will occur over 12-16 sessions via phone calls, text messages, video calls and/or in-person meetings as desired/convenient and in accordance with local public health guidelines.
Eligibility Criteria
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Inclusion Criteria
* Patient is 40-68yo;
* Patient has an email address;
* Patient has at least one behavioural risk factor not at target or at least one cancer screening overdue as defined below:
* Score of less than 9 on the Mediterranean Diet Tool
* Less than 150 minutes of moderate to vigorous physical activity per week
* Smoked a cigarette within the last 30 days
* Average number of drinks per day is ≥1 and/or has \>1 drink on any single occasion
* Due or overdue for one or more of breast, cervical or colorectal cancer screenings;
* Patient has a valid number for the provincial health insurance program (Ontario Health Insurance Program \[OHIP\]); and
* Patient's medical records for, at least the previous 3 years are accessible through their family physician.
Exclusion Criteria
* Patient is unable or unwilling to communicate with the study team to collect outcomes in English via both email and phone; or
* Patient's primary care provider has identified medical comorbidities or other conditions at baseline that might interfere with the patient's ability to follow through on the intervention.
40 Years
68 Years
ALL
Yes
Sponsors
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Canadian Cancer Society (CCS)
OTHER
Public Health Agency of Canada (PHAC)
OTHER_GOV
Women's College Hospital Foundation
UNKNOWN
Women's College Hospital Family Practice Health Centre
UNKNOWN
Barrie and Community Family Health Team
UNKNOWN
University Health Network, Toronto
OTHER
Applied Health Research Centre
OTHER
Summerville Family Health Team
UNKNOWN
Women's College Hospital
OTHER
Responsible Party
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Noah Ivers
Clinician-Scientist
Principal Investigators
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Noah M Ivers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Aisha Lofters, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Locations
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Barrie and Community Family Health Team
Barrie, Ontario, Canada
Summerville Family Health Team
Mississauga, Ontario, Canada
Women's College Hospital Family Practice Health Centre
Toronto, Ontario, Canada
Countries
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References
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Grunfeld E, Manca D, Moineddin R, Thorpe KE, Hoch JS, Campbell-Scherer D, Meaney C, Rogers J, Beca J, Krueger P, Mamdani M; BETTER Trial Investigators. Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial. BMC Fam Pract. 2013 Nov 20;14:175. doi: 10.1186/1471-2296-14-175.
Bodenheimer TS, Smith MD. Primary care: proposed solutions to the physician shortage without training more physicians. Health Aff (Millwood). 2013 Nov;32(11):1881-6. doi: 10.1377/hlthaff.2013.0234.
Kithulegoda N, Williams C, Senthilmurugan A, Aimola S, Atkinson J, Banerjee AT, Bazeghi F, Bender JL, Flynn S, Ghatage L, Goulbourne E, Grunfeld E, Heisey R, Rao A, Sutcliffe K, Lofters A, Ivers NM. Assessing the effectiveness of "BETTER Women", a community-based, primary care-linked peer health coaching programme for chronic disease prevention: protocol for a pragmatic, wait-list controlled, type 1 hybrid effectiveness-implementation trial. BMJ Open. 2024 Jul 24;14(7):e085933. doi: 10.1136/bmjopen-2024-085933.
Related Links
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Information about the Alcohol Use Disorders Identification Test (AUDIT)
Mediterranean Diet Toolkit (Nov 2018) by Dietitians of Canada
The screening tool used to provide the physical activity index (PAI)
Other Identifiers
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2020-0079-E
Identifier Type: -
Identifier Source: org_study_id
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