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The Virtual BETTER Study

Primary Purpose

Delivery Modality of BETTER Intervention

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
In-Person Prevention Practitioner Visit
Video-Call Prevention Practitioner Visit
Phone Prevention Practitioner Visit
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delivery Modality of BETTER Intervention focused on measuring chronic disease, lifestyle, screening, physical activity, diet

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

In-Person

Video

Phone

Arm Description

Standard Prevention Practitioner visit that will take place in-person

Prevention Practitioner visit that will take place through video call

Prevention Practitioner visit that will take place through phone call

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
May 12, 2022
Last Updated
April 5, 2023
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT05425797
Brief Title
The Virtual BETTER Study
Official Title
Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Primary Care Virtually: the Virtual BETTER Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery Modality of BETTER Intervention
Keywords
chronic disease, lifestyle, screening, physical activity, diet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-Person
Arm Type
Active Comparator
Arm Description
Standard Prevention Practitioner visit that will take place in-person
Arm Title
Video
Arm Type
Experimental
Arm Description
Prevention Practitioner visit that will take place through video call
Arm Title
Phone
Arm Type
Experimental
Arm Description
Prevention Practitioner visit that will take place through phone call
Intervention Type
Other
Intervention Name(s)
In-Person Prevention Practitioner Visit
Intervention Description
BETTER Intervention visit with PP which will take place in-person at the PP's office.
Intervention Type
Other
Intervention Name(s)
Video-Call Prevention Practitioner Visit
Intervention Description
BETTER Intervention visit with PP which will take place virtually via a secure video system.
Intervention Type
Other
Intervention Name(s)
Phone Prevention Practitioner Visit
Intervention Description
BETTER Intervention visit with PP which will take place via telephone.
Primary Outcome Measure Information:
Title
Readiness to Change (University of Rhode Island Change Assessment Scale: URICA)
Description
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)
Time Frame
Post-Visit (less than 1 week after visit)
Secondary Outcome Measure Information:
Title
Satisfaction of Modalities (Client Satisfaction Questionnaire: CSQ-4)
Description
To assess satisfaction with the three different delivery modalities. Min Score: 4 Max Score: 16 Higher scores indicate higher satisfaction (better outcome)
Time Frame
Post-Visit (less than 1 week after visit)
Title
Acceptability
Description
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)
Time Frame
Enrollment (Pre-visit)
Title
Accessibility
Description
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)
Time Frame
Enrollment (Pre-visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kris Aubrey-Bassler, MD
Phone
709-777-8304
Email
kaubrey@mun.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kris Aubrey-Bassler, MD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kris Aubrey-Bassler
Phone
7097778304
Email
kaubrey@mun.ca

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/16418496
Description
link to pubmed abstract for this pmid 16418496
URL
https://www.ncbi.nlm.nih.gov/pubmed/22042959
Description
link to pubmed abstract for this pmid 22042959
URL
https://www.ncbi.nlm.nih.gov/pubmed/25896265
Description
link to pubmed abstract for this pmid 25896265
URL
https://www.ncbi.nlm.nih.gov/pubmed/24252125
Description
link to pubmed abstract for this pmid 24252125
URL
https://www.ncbi.nlm.nih.gov/pubmed/12660210
Description
link to pubmed abstract for this pmid 12660210
URL
https://www.ncbi.nlm.nih.gov/pubmed/11583121
Description
link to pubmed abstract for this pmid 11583121
URL
https://www.ncbi.nlm.nih.gov/pubmed/25077119
Description
link to pubmed abstract for this pmid 25077119
URL
https://www.ncbi.nlm.nih.gov/pubmed/21911548
Description
link to pubmed abstract for this pmid 21911548
URL
https://www.ncbi.nlm.nih.gov/pubmed/10834899
Description
link to pubmed abstract for this pmid 10834899
URL
https://www.ncbi.nlm.nih.gov/pubmed/16388172
Description
link to pubmed abstract for this pmid 16388172
URL
https://www.ncbi.nlm.nih.gov/pubmed/25572619
Description
link to pubmed abstract for this pmid 25572619
URL
https://www.ncbi.nlm.nih.gov/pubmed/22972732
Description
link to pubmed abstract for this pmid 22972732
URL
https://www.ncbi.nlm.nih.gov/pubmed/15275669
Description
link to pubmed abstract for this pmid 15275669
URL
https://www.ncbi.nlm.nih.gov/pubmed/26431861
Description
link to pubmed abstract for this pmid 26431861
URL
https://www.ncbi.nlm.nih.gov/pubmed/30646223
Description
link to pubmed abstract for this pmid 30646223
URL
https://www.ncbi.nlm.nih.gov/pubmed/32658298
Description
link to pubmed abstract for this pmid 32658298
URL
https://www.ncbi.nlm.nih.gov/pubmed/33496775
Description
link to pubmed abstract for this pmid 33496775
URL
https://www.ncbi.nlm.nih.gov/pubmed/31019728
Description
link to pubmed abstract for this pmid 31019728
URL
https://www.ncbi.nlm.nih.gov/pubmed/32003816
Description
link to pubmed abstract for this pmid 32003816
URL
https://www.ncbi.nlm.nih.gov/pubmed/19032513
Description
link to pubmed abstract for this pmid 19032513
URL
https://www.ncbi.nlm.nih.gov/pubmed/27165047
Description
link to pubmed abstract for this pmid 27165047

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