The Virtual BETTER Study

NCT ID: NCT05425797

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-08-30

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).

Conditions

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Delivery Modality of BETTER Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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In-Person

Standard Prevention Practitioner visit that will take place in-person

Group Type ACTIVE_COMPARATOR

In-Person Prevention Practitioner Visit

Intervention Type OTHER

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

Video

Prevention Practitioner visit that will take place through video call

Group Type EXPERIMENTAL

Video-Call Prevention Practitioner Visit

Intervention Type OTHER

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

Phone

Prevention Practitioner visit that will take place through phone call

Group Type EXPERIMENTAL

Phone Prevention Practitioner Visit

Intervention Type OTHER

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

Interventions

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In-Person Prevention Practitioner Visit

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

Intervention Type OTHER

Video-Call Prevention Practitioner Visit

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

Intervention Type OTHER

Phone Prevention Practitioner Visit

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Kris Aubrey-Bassler

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kris Aubrey-Bassler, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

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Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 16418496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22042959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25896265 (View on PubMed)

Elmslie K. Against the Growing Burden of Disease. Ottawa, ON: Public Health Agency of Canada.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24252125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12660210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11583121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25077119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21911548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10834899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16388172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25572619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22972732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15275669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26431861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31162756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30646223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32658298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33496775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31019728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32003816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19032513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27165047 (View on PubMed)

Donner A, Birkett N, Buck C. Randomization by cluster. Sample size requirements and analysis. Am J Epidemiol. 1981 Dec;114(6):906-14. doi: 10.1093/oxfordjournals.aje.a113261. No abstract available.

Reference Type BACKGROUND
PMID: 7315838 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/16418496

link to pubmed abstract for this pmid 16418496

https://www.ncbi.nlm.nih.gov/pubmed/22042959

link to pubmed abstract for this pmid 22042959

https://www.ncbi.nlm.nih.gov/pubmed/25896265

link to pubmed abstract for this pmid 25896265

https://www.ncbi.nlm.nih.gov/pubmed/24252125

link to pubmed abstract for this pmid 24252125

https://www.ncbi.nlm.nih.gov/pubmed/12660210

link to pubmed abstract for this pmid 12660210

https://www.ncbi.nlm.nih.gov/pubmed/11583121

link to pubmed abstract for this pmid 11583121

https://www.ncbi.nlm.nih.gov/pubmed/25077119

link to pubmed abstract for this pmid 25077119

https://www.ncbi.nlm.nih.gov/pubmed/21911548

link to pubmed abstract for this pmid 21911548

https://www.ncbi.nlm.nih.gov/pubmed/10834899

link to pubmed abstract for this pmid 10834899

https://www.ncbi.nlm.nih.gov/pubmed/16388172

link to pubmed abstract for this pmid 16388172

https://www.ncbi.nlm.nih.gov/pubmed/25572619

link to pubmed abstract for this pmid 25572619

https://www.ncbi.nlm.nih.gov/pubmed/22972732

link to pubmed abstract for this pmid 22972732

https://www.ncbi.nlm.nih.gov/pubmed/15275669

link to pubmed abstract for this pmid 15275669

https://www.ncbi.nlm.nih.gov/pubmed/26431861

link to pubmed abstract for this pmid 26431861

https://www.ncbi.nlm.nih.gov/pubmed/30646223

link to pubmed abstract for this pmid 30646223

https://www.ncbi.nlm.nih.gov/pubmed/32658298

link to pubmed abstract for this pmid 32658298

https://www.ncbi.nlm.nih.gov/pubmed/33496775

link to pubmed abstract for this pmid 33496775

https://www.ncbi.nlm.nih.gov/pubmed/31019728

link to pubmed abstract for this pmid 31019728

https://www.ncbi.nlm.nih.gov/pubmed/32003816

link to pubmed abstract for this pmid 32003816

https://www.ncbi.nlm.nih.gov/pubmed/19032513

link to pubmed abstract for this pmid 19032513

https://www.ncbi.nlm.nih.gov/pubmed/27165047

link to pubmed abstract for this pmid 27165047

Other Identifiers

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CIHRVirtualBETTER

Identifier Type: -

Identifier Source: org_study_id