The Virtual BETTER Study

November 29, 2024 updated by: Kris Aubrey-Bassler, Memorial University of Newfoundland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B3V6
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Persons aged 40-70
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readiness to Change (University of Rhode Island Change Assessment Scale: URICA)
Time Frame: 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)
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)
Time Frame: 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)
Post-Visit (less than 1 week after visit)
Acceptability
Time Frame: 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)
Enrollment (Pre-visit)
Accessibility
Time Frame: 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)
Enrollment (Pre-visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial University of Newfoundland

Investigators

  • Principal Investigator: Kris Aubrey-Bassler, MD, Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHRVirtualBETTER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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