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
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
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
NCT ID
NCT05425797
First Posted
May 12, 2022
Last Updated
April 5, 2023
Sponsor
Memorial University of Newfoundland
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
Citations:
PubMed Identifier
16418496
Citation
Grunfeld E, Levine MN, Julian JA, Coyle D, Szechtman B, Mirsky D, Verma S, Dent S, Sawka C, Pritchard KI, Ginsburg D, Wood M, Whelan T. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. J Clin Oncol. 2006 Feb 20;24(6):848-55. doi: 10.1200/JCO.2005.03.2235. Epub 2006 Jan 17.
Results Reference
background
PubMed Identifier
22042959
Citation
Grunfeld E, Julian JA, Pond G, Maunsell E, Coyle D, Folkes A, Joy AA, Provencher L, Rayson D, Rheaume DE, Porter GA, Paszat LF, Pritchard KI, Robidoux A, Smith S, Sussman J, Dent S, Sisler J, Wiernikowski J, Levine MN. Evaluating survivorship care plans: results of a randomized, clinical trial of patients with breast cancer. J Clin Oncol. 2011 Dec 20;29(36):4755-62. doi: 10.1200/JCO.2011.36.8373. Epub 2011 Oct 31.
Results Reference
background
PubMed Identifier
25896265
Citation
Boekhout AH, Maunsell E, Pond GR, Julian JA, Coyle D, Levine MN, Grunfeld E; FUPII Trial Investigators. A survivorship care plan for breast cancer survivors: extended results of a randomized clinical trial. J Cancer Surviv. 2015 Dec;9(4):683-91. doi: 10.1007/s11764-015-0443-1. Epub 2015 Apr 21.
Results Reference
background
Citation
Elmslie K. Against the Growing Burden of Disease. Ottawa, ON: Public Health Agency of Canada.
Results Reference
background
PubMed Identifier
24252125
Citation
Grunfeld E, Manca D, Moineddin R, Thorpe KE, Hoch JS, Campbell-Scherer D, Meaney C, Rogers J, Beca J, Krueger P, Mamdani M; BETTER Trial Investigators. Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial. BMC Fam Pract. 2013 Nov 20;14:175. doi: 10.1186/1471-2296-14-175.
Results Reference
background
PubMed Identifier
12660210
Citation
Yarnall KS, Pollak KI, Ostbye T, Krause KM, Michener JL. Primary care: is there enough time for prevention? Am J Public Health. 2003 Apr;93(4):635-41. doi: 10.2105/ajph.93.4.635.
Results Reference
background
PubMed Identifier
11583121
Citation
Grol R. Successes and failures in the implementation of evidence-based guidelines for clinical practice. Med Care. 2001 Aug;39(8 Suppl 2):II46-54. doi: 10.1097/00005650-200108002-00003.
Results Reference
background
PubMed Identifier
25077119
Citation
Campbell-Scherer D, Rogers J, Manca D, Lang-Robertson K, Bell S, Salvalaggio G, Greiver M, Korownyk C, Klein D, Carroll JC, Kahan M, Meuser J, Buchman S, Barrett RM, Grunfeld E. Guideline harmonization and implementation plan for the BETTER trial: Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Family Practice. CMAJ Open. 2014 Jan 22;2(1):E1-E10. doi: 10.9778/cmajo.20130040. eCollection 2014 Jan.
Results Reference
background
PubMed Identifier
21911548
Citation
Tobe SW, Stone JA, Brouwers M, Bhattacharyya O, Walker KM, Dawes M, Genest J Jr, Grover S, Gubitz G, Lau D, Pipe A, Selby P, Tremblay MS, Warburton DE, Ward R, Woo V, Leiter LA, Liu PP. Harmonization of guidelines for the prevention and treatment of cardiovascular disease: the C-CHANGE Initiative. CMAJ. 2011 Oct 18;183(15):E1135-50. doi: 10.1503/cmaj.101508. Epub 2011 Sep 12. No abstract available. Erratum In: CMAJ. 2012 Feb 21;184(3):327.
Results Reference
background
PubMed Identifier
10834899
Citation
Mair F, Whitten P. Systematic review of studies of patient satisfaction with telemedicine. BMJ. 2000 Jun 3;320(7248):1517-20. doi: 10.1136/bmj.320.7248.1517.
Results Reference
background
PubMed Identifier
16388172
Citation
Whitten P, Love B. Patient and provider satisfaction with the use of telemedicine: overview and rationale for cautious enthusiasm. J Postgrad Med. 2005 Oct-Dec;51(4):294-300.
Results Reference
background
PubMed Identifier
25572619
Citation
Bully P, Sanchez A, Zabaleta-del-Olmo E, Pombo H, Grandes G. Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S76-93. doi: 10.1016/j.ypmed.2014.12.020. Epub 2015 Jan 5.
Results Reference
background
PubMed Identifier
22972732
Citation
Grunfeld E, Moineddin R, Gunraj N, Del Giudice ME, Hodgson DC, Kwon JS, Elit L. Cancer screening practices of cancer survivors: population-based, longitudinal study. Can Fam Physician. 2012 Sep;58(9):980-6.
Results Reference
background
PubMed Identifier
15275669
Citation
Pronk NP, Peek CJ, Goldstein MG. Addressing multiple behavioral risk factors in primary care. A synthesis of current knowledge and stakeholder dialogue sessions. Am J Prev Med. 2004 Aug;27(2 Suppl):4-17. doi: 10.1016/j.amepre.2004.04.024.
Results Reference
background
PubMed Identifier
26431861
Citation
Coburn C, Collingridge D. Primary care and cancer: integration is key. Lancet Oncol. 2015 Sep;16(12):1225. doi: 10.1016/S1470-2045(15)00323-X. No abstract available.
Results Reference
background
PubMed Identifier
31162756
Citation
Kelleher SA, Winger JG, Dorfman CS, Ingle KK, Moskovich AA, Abernethy AP, Keefe FJ, Samsa GP, Kimmick GG, Somers TJ. A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. Psychooncology. 2019 Aug;28(8):1671-1678. doi: 10.1002/pon.5141. Epub 2019 Jun 19. Erratum In: Psychooncology. 2020 Jan;29(1):237.
Results Reference
background
PubMed Identifier
30646223
Citation
Armstrong AW, Chambers CJ, Maverakis E, Cheng MY, Dunnick CA, Chren MM, Gelfand JM, Wong DJ, Gibbons BM, Gibbons CM, Torres J, Steel AC, Wang EA, Clark CM, Singh S, Kornmehl HA, Wilken R, Florek AG, Ford AR, Ma C, Ehsani-Chimeh N, Boddu S, Fujita M, Young PM, Rivas-Sanchez C, Cornejo BI, Serna LC, Carlson ER, Lane CJ. Effectiveness of Online vs In-Person Care for Adults With Psoriasis: A Randomized Clinical Trial. JAMA Netw Open. 2018 Oct 5;1(6):e183062. doi: 10.1001/jamanetworkopen.2018.3062.
Results Reference
background
PubMed Identifier
32658298
Citation
Arnedt JT, Conroy DA, Mooney A, Furgal A, Sen A, Eisenberg D. Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial. Sleep. 2021 Jan 21;44(1):zsaa136. doi: 10.1093/sleep/zsaa136.
Results Reference
background
PubMed Identifier
33496775
Citation
Befort CA, VanWormer JJ, Desouza C, Ellerbeck EF, Gajewski B, Kimminau KS, Greiner KA, Perri MG, Brown AR, Pathak RD, Huang TT, Eiland L, Drincic A. Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial. JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855.
Results Reference
background
PubMed Identifier
31019728
Citation
Clark DO, Keith N, Weiner M, Xu H. Outcomes of an RCT of videoconference vs. in-person or in-clinic nutrition and exercise in midlife adults with obesity. Obes Sci Pract. 2019 Feb 8;5(2):111-119. doi: 10.1002/osp4.318. eCollection 2019 Apr.
Results Reference
background
PubMed Identifier
32003816
Citation
Guille C, Simpson AN, Douglas E, Boyars L, Cristaldi K, McElligott J, Johnson D, Brady K. Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920177. doi: 10.1001/jamanetworkopen.2019.20177.
Results Reference
background
PubMed Identifier
19032513
Citation
Lerdal A, Moe B, Digre E, Harding T, Kristensen F, Grov EK, Bakken LN, Eklund ML, Ruud I, Rossi JS. Stages of Change--continuous measure (URICA-E2): psychometrics of a Norwegian version. J Adv Nurs. 2009 Jan;65(1):193-202. doi: 10.1111/j.1365-2648.2008.04842.x. Epub 2008 Nov 14.
Results Reference
background
PubMed Identifier
27165047
Citation
Pietrabissa G, Sorgente A, Rossi A, Simpson S, Riva G, Manzoni GM, Prochaska JO, Prochaska JM, Cattivelli R, Castelnuovo G. Stages of change in obesity and weight management: factorial structure of the Italian version of the University of Rhode Island Change Assessment Scale. Eat Weight Disord. 2017 Jun;22(2):361-367. doi: 10.1007/s40519-016-0289-1. Epub 2016 May 10.
Results Reference
background
Citation
from the BETTER RCT (0.381) to calculate a sample inflation factor which produced an estimated total sample size requirement of 160 patients from 10 practices.<sup data-refid="34" data-citation="~[(34)Donner A, Birkett N, Buck C, Randomization by cluster. Sample size requirements and analysis., Am J Epidemiol. 1981 Dec;114(6):906-14
Results Reference
background
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
Learn more about this trial
The Virtual BETTER Study
We'll reach out to this number within 24 hrs