The Virtual BETTER Study

Sponsor

Memorial University of Newfoundland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05425797

Collaborator

(none)

192

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Delivery Modality of BETTER Intervention	Other: In-Person Prevention Practitioner Visit Other: Video-Call Prevention Practitioner Visit Other: Phone Prevention Practitioner Visit	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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.

Masking:

Single (Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: In-Person

Standard Prevention Practitioner visit that will take place in-person

Other: In-Person Prevention Practitioner Visit

BETTER Intervention visit with PP which will take place in-person at the PP's office.

Experimental: Video

Prevention Practitioner visit that will take place through video call

Other: Video-Call Prevention Practitioner Visit

BETTER Intervention visit with PP which will take place virtually via a secure video system.

Experimental: Phone

Prevention Practitioner visit that will take place through phone call

Other: Phone Prevention Practitioner Visit

BETTER Intervention visit with PP which will take place via telephone.

Outcome Measures

Primary Outcome Measures

Readiness to Change (University of Rhode Island Change Assessment Scale: URICA) [Post-Visit (less than 1 week after visit)]
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)

Secondary Outcome Measures

Satisfaction of Modalities (Client Satisfaction Questionnaire: CSQ-4) [Post-Visit (less than 1 week after visit)]
To assess satisfaction with the three different delivery modalities. Min Score: 4 Max Score: 16 Higher scores indicate higher satisfaction (better outcome)
Acceptability [Enrollment (Pre-visit)]
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)
Accessibility [Enrollment (Pre-visit)]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.