The Virtual BETTER Study

Study Overview
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Brief Summary
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The focus of this project is to examine how delivering virtual care impacts health behaviour change for patients with chronic illnesses compared to in-person visits using a chronic disease prevention and screening (CDPS) program called BETTER (Building on Existing Tools To ImprovE Chronic Disease PRevention and Screening in Primary Care).

Detailed Description
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While the current pandemic has launched a likely irreversible transition towards increased utilization of virtual methods for delivery of healthcare, we have only a very superficial understanding of how this shift will affect health outcomes and equity of access to health services. Several randomized trials comparing virtual to in-person delivery of health services have been completed, but none have examined the effect of interventions to address health behaviours, arguably one of the most challenging issues in healthcare and one that is most sensitive to the therapeutic relationship and modifiers to that relationship such as the mode of communication. The focus of this project is to examine how delivering virtual care impacts health behaviour change for patients with chronic illnesses compared to in-person visits using a chronic disease prevention and screening (CDPS) program called BETTER (Building on Existing Tools To ImprovE Chronic Disease PRevention and Screening in Primary Care).

Official Title
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Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Primary Care Virtually: the Virtual BETTER Study

Conditions
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Delivery Modality of BETTER Intervention

Intervention / Treatment
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* Other: In-Person Prevention Practitioner Visit
* Other: Video-Call Prevention Practitioner Visit
* Other: Phone Prevention Practitioner Visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons aged 40-65 Persons who are already booking a BETTER prevention visit. Exclusion Criteria: Persons with the presence of a terminal illness Persons in active treatment (i.e., systemic and/or radiation therapy) for cancer. Persons who are unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will study two experimental groups (telephone and video) compared to the control group of in-person BETTER intervention delivery. Mode of delivery will be randomized between patients. If it is not feasible yo offer all three (e.g. PP only has capacity to offer virtual appointments, study population lives greater than 30 minutes travel from PP location), a subset of the three will be offered.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-Person<br>Standard Prevention Practitioner visit that will take place in-person | Other: In-Person Prevention Practitioner Visit<br>* BETTER Intervention visit with PP which will take place in-person at the PP's office.<br>|
| Experimental: Video<br>Prevention Practitioner visit that will take place through video call | Other: Video-Call Prevention Practitioner Visit<br>* BETTER Intervention visit with PP which will take place virtually via a secure video system.<br>|
| Experimental: Phone<br>Prevention Practitioner visit that will take place through phone call | Other: Phone Prevention Practitioner Visit<br>* BETTER Intervention visit with PP which will take place via telephone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readiness to Change (University of Rhode Island Change Assessment Scale: URICA) | To compare readiness to implement lifestyle change after telephone, video, and in-person BETTER Prevention visits. Min Score: 4 Max Score: 20 Higher scores indicate a higher readiness to change (better outcome) | Post-Visit (less than 1 week after visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of Modalities (Client Satisfaction Questionnaire: CSQ-4) | To assess satisfaction with the three different delivery modalities. Min Score: 4 Max Score: 16 Higher scores indicate higher satisfaction (better outcome) | Post-Visit (less than 1 week after visit) | 
| Acceptability | To assess acceptability of the three different delivery modalities. Assessed through enrollment questionnaire which will ask which delivery method they agree to. (Not scored on scale) | Enrollment (Pre-visit) | 
| Accessibility | To assess accessibility of the three different delivery modalities. Assessed through enrollment questionnaire which will ask why they chose which delivery method they did. (Not scored on scale) | Enrollment (Pre-visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic disease, lifestyle, screening, physical activity, diet