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Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04746859
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : April 14, 2022
Sponsor:
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
Information provided by (Responsible Party):
Noah Ivers, Women's College Hospital

Brief Summary:
The Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care (BETTER) Program allows patients in primary care to have a dedicated visit with a prevention practitioner to discuss chronic disease prevention and cancer screening. A prevention practitioner is a health professional, working in primary care, who has received additional training to discuss chronic disease prevention and screening and develop health goals with patients through shared decision-making. Previous studies have shown that this approach increases the number of prevention and screening actions completed by program participants. However, maintenance of health behaviour changes is difficult without on-going support. There is also some evidence that peer-delivered coaching can improve health outcomes in community settings. As such, the BETTER Women program extends the BETTER program by focusing on 40 to 65-year-old women and providing time-limited support for health behaviour change through peer health coaches. Coaches are volunteers - trained in techniques to support health behaviour change - who support women to achieve their health goals over a 6-month period. In this study, the investigators will explore: (i) whether patients who participate in health coaching after a prevention visit are more likely to increase the number of prevention and screening actions that they complete after six months, compared to women who participate in a prevention visit but do not get health coaching; (ii) whether the intervention effects endure six months after the intervention ends; and (iii) the implementation of the program to learn about factors that affect various aspects of the success and sustainability of the program.

Condition or disease Intervention/treatment Phase
Chronic Disease Cancer Other: Prevention Visit Behavioral: Peer health coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: BETTER Women: Community-Based, Primary Care-Linked Peer Health Coaching to Achieve Evidence-Based Preventive Care Goals - A Pragmatic, Wait-List Controlled Effectiveness-Implementation Trial
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: 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.
Other: 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.

Behavioral: 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.
Other: 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.




Primary Outcome Measures :
  1. Increased targeted behaviours from baseline [ Time Frame: 0, 6 months ]
    The primary outcome is binary and defined as whether a patient increased the number of completed targeted behaviours from baseline to end of follow-up at 6 months. The targeted behaviours include the status (up to date or out of date) of three cancer screening tests (cervical, breast, colorectal) and the status (meeting evidence-based target or not) of four behavioural determinants for risk of cancer and chronic disease (diet, smoking, alcohol use, physical activity). If a patient meets at least one more target at 6 months than they met at baseline, their outcome will be considered positive.


Secondary Outcome Measures :
  1. Goal achievement [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Percentage of patient-set health goals that was achieved

  2. Breast cancer screening status [ Time Frame: 0, 6 months ]
    Binary assessment of whether the patient is up to date on their breast cancer screening, as per their history and level of risk

  3. Cervical cancer screening status [ Time Frame: 0, 6 months ]
    Binary assessment of whether the patient is up to date on their cervical cancer screening, as per their history and level of risk

  4. Colorectal cancer screening status [ Time Frame: 0, 6 months ]
    Binary assessment of whether the patient is up to date on their colorectal cancer screening, as per their history and level of risk

  5. Diet status [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the patient's Mediterranean Diet Score is at target (≥9)

  6. Improvement in diet [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether there was an evidence-based improvement (change ≥2) in diet between assessment points

  7. Diet management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient took at least one meaningful action towards diet management

  8. Physical activity status [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether time (in minutes) spent doing moderate to vigorous physical activity in the last seven days is at the evidence-based target (≥150minutes)

  9. Improvement in physical activity [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether or not there was improvement in the physical activity index (PAI) between assessment points

  10. Physical activity management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient took at least one meaningful action towards physical activity management

  11. Smoking status [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether smoking status meets the target of abstinent for the last 30 days

  12. Improvement in smoking [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the patient's cigarette consumption category, based on consumption of cigarettes per day (cpd), has improved (i.e., cpd decreased) between assessment points

  13. Smoking management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient took at least one meaningful action towards management of smoking behaviour

  14. Alcohol use status [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether alcohol use is at evidence-based target, i.e., number of drinks per day is <1 and never having ≥1 drink on one occasion

  15. Improvement in alcohol use [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether AUDIT risk category has improved (i.e., risk level has decreased) between assessment points

  16. Alcohol use management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient took at least one meaningful action towards management of alcohol use

  17. Up-to-date measurement of glycated haemoglobin (HbA1c) [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the latest HbA1c measurement is up to date at study end, as per patient's characteristics

  18. HbA1c control [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the latest measurement, at study end, is up to date and at target (<7%)

  19. HbA1c [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    The most recent and up to date HbA1c measurement for patients with diabetes mellitus (DM)

  20. Glycemic management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient with DM (HbA1c not at target) has taken any meaningful actions towards management of blood sugar through initiation of new antihyperglycemic medication, up-titration of existing antihyperglycemic medications, or discussion with healthcare professional regarding behavioural changes needed to improve blood sugar

  21. Up-to-date measurement of blood pressure (BP) [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the latest BP measurement is up to date, as per patient's characteristics

  22. BP control [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the most recent measurement is up to date and at target as per patient's characteristics

  23. Systolic BP [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    The most recent and up to date systolic BP measurement

  24. Diastolic BP [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    The most recent and up to date diastolic BP measurement

  25. Hypertension management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient with BP not at target has taken at least one action towards management of hypertension through initiation of new blood pressure medication, up-titration of existing blood pressure medication, or discussion with healthcare professional regarding behavioural changes needed to improve blood pressure

  26. Up-to-date assessment of low-density lipoprotein (LDL) cholesterol [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the latest LDL measurement is up to date, as per patient's characteristics

  27. LDL control [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether the most recent LDL measurement is up to date and at target as per patient's characteristics

  28. LDL [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    The most recent and up to date LDL measurement

  29. LDL cholesterol management [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient with LDL not at target has taken at least one action towards management of LDL through initiation of new LDL medication, up-titration of existing LDL medication, or discussion with healthcare professional regarding behavioural changes needed to improve cholesterol

  30. Up-to-date assessment for obesity [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether body mass index (BMI) calculation or waist circumference (WC) measurement is up to date, as per patient's characteristics

  31. BMI control [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    Binary assessment of whether latest, up to date BMI is within target (≤ 30kg/m2)

  32. Management of obesity [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Binary assessment of whether patient with BMI not at target took any meaningful actions towards management of obesity through use of medication or discussion with healthcare professional regarding behavioural changes needed to manage obesity


Other Outcome Measures:
  1. Cardiovascular risk [ Time Frame: 0, 6 months; 12 months for intervention group only ]
    10-year cardiovascular risk

  2. Health-related quality of life [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    Health utility score based on European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) health state

  3. Quality-adjusted life year (QALY) [ Time Frame: 0, 3, 6 months; 12 months for intervention group only ]
    An estimation of the combined health utility values derived from responses from EQ-5D-5L and length of life experienced by patient, between measurement time points

  4. Outpatient visits [ Time Frame: 6 months ]
    Number of times patient accessed publicly funded outpatient healthcare services (e.g., visit to primary care physician, outpatient hospital-based services) while enrolled in the study

  5. Emergency room (ER) visits [ Time Frame: 6 months ]
    Number of times patient accessed publicly funded healthcare services from a hospital emergency room while enrolled in the study

  6. Total healthcare costs [ Time Frame: 6 months ]
    The total cost of publicly funded healthcare utilization (outside of delivery of the intervention) by patient while enrolled in the study

  7. Intervention cost/patient [ Time Frame: 4 years ]
    Incremental cost of the intervention (i.e., delivery of peer health coaching only) per patient

  8. Duration of intervention effect [ Time Frame: 6, 12 months ]
    This outcome is ordinal and calculated *only for intervention group patients*. It represents the nature of the change in the number of completed targeted behaviours from end of intervention (at 6 months) to end of follow-up (at 12 months). The targeted behaviours include the status (meeting evidence-based target or not) of four behavioural determinants for risk of cancer and chronic disease (diet, smoking, alcohol use, physical activity). If a patient meets more targets at 12 months compared to 6 months, the patient will be said to have improved. If the same number of targets are met, the patient will be said to be unchanged. If fewer targets are met, the patient will be said to have worsened.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Any person who self-identifies as a woman, regardless of sex assigned at birth, and meets all other eligibility criteria will be invited to participate.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient identifies as a woman;
  • Patient is 40-65yo;
  • 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 to give informed consent in English due to language, literacy, or competence;
  • 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.

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): NCT04746859


Contacts
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Contact: Natasha Kithulegoda, MPH 416-323-6400 ext 8356 Natasha.Kithulegoda@wchospital.ca
Contact: Camille K Williams, PhD 416 323 6400 ext 5220 Camille.Williams@wchospital.ca

Locations
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Canada, Ontario
Barrie and Community Family Health Team Recruiting
Barrie, Ontario, Canada, L4N 7L3
Contact: Natasha Kithulegoda, MPH    416-323-6400 ext 8356    Natasha.Kithulegoda@wchospital.ca   
Contact: Camille K Williams, PhD    416 323 6400 ext 5220    Camille.Williams@wchospital.ca   
Principal Investigator: Stu Murdoch, MD         
Summerville Family Health Team Recruiting
Mississauga, Ontario, Canada, L5B 2P7
Contact: Natasha Kithulegoda, MPH    416-323-6400 ext 8356    natasha.kithulegoda@wchospital.ca   
Contact: Camille K Williams, PhD    416 323 6400 ext 5220    camille.williams@wchospital.ca   
Principal Investigator: Priya Rajput, MD         
Women's College Hospital Family Practice Health Centre Recruiting
Toronto, Ontario, Canada, M5S 1B3
Contact: Natasha Kithulegoda, MPH    416-323-6400 ext 8356    Natasha.Kithulegoda@wchospital.ca   
Contact: Camille K Williams, PhD    416 323 6400 ext 5220    Camille.Williams@wchospital.ca   
Principal Investigator: Dara Maker, MD         
Sponsors and Collaborators
Women's College Hospital
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
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Principal Investigator: Noah M Ivers, MD, PhD Women's College Hospital
Principal Investigator: Aisha Lofters, MD, PhD Women's College Hospital
Additional Information:
Publications:
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Responsible Party: Noah Ivers, Clinician-Scientist, Women's College Hospital
ClinicalTrials.gov Identifier: NCT04746859    
Other Study ID Numbers: 2020-0079-E
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noah Ivers, Women's College Hospital:
chronic disease prevention
cancer screening
community health worker
family practice
randomized control trial
hybrid design
process evaluation
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes