NCT05425797

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

May 12, 2022

Last Update Submit

November 29, 2024

Conditions

Delivery Modality of BETTER Intervention

Keywords

chronic diseaselifestylescreeningphysical activitydiet

Outcome Measures

Primary Outcomes (1)

  • 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)

    Post-Visit (less than 1 week after visit)

Secondary Outcomes (3)

  • Satisfaction of Modalities (Client Satisfaction Questionnaire: CSQ-4)

    Post-Visit (less than 1 week after visit)

  • Acceptability

    Enrollment (Pre-visit)

  • Accessibility

    Enrollment (Pre-visit)

Study Arms (3)

In-Person

ACTIVE COMPARATOR

Standard Prevention Practitioner visit that will take place in-person

Other: In-Person Prevention Practitioner Visit

Video

EXPERIMENTAL

Prevention Practitioner visit that will take place through video call

Other: Video-Call Prevention Practitioner Visit

Phone

EXPERIMENTAL

Prevention Practitioner visit that will take place through phone call

Other: Phone Prevention Practitioner Visit

Interventions

In-Person Prevention Practitioner VisitOTHER

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

In-Person
Video-Call Prevention Practitioner VisitOTHER

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

Video
Phone Prevention Practitioner VisitOTHER

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

Phone

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons aged 40-70
  • Persons who are already booking a BETTER prevention visit.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B3V6, Canada

Location

Related Publications (24)

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    PMID: 16418496BACKGROUND

  • 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.

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  • 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.

    PMID: 25896265BACKGROUND

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

    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.

    PMID: 24252125BACKGROUND

  • 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.

    PMID: 12660210BACKGROUND

  • 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.

    PMID: 11583121BACKGROUND

  • 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.

    PMID: 25077119BACKGROUND

  • 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.

    PMID: 21911548BACKGROUND

  • 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.

    PMID: 10834899BACKGROUND

  • 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.

    PMID: 16388172BACKGROUND

  • 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.

    PMID: 25572619BACKGROUND

  • 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.

    PMID: 22972732BACKGROUND

  • 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.

    PMID: 15275669BACKGROUND

  • 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.

    PMID: 26431861BACKGROUND

  • 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.

    PMID: 31162756BACKGROUND

  • 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.

    PMID: 30646223BACKGROUND

  • 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.

    PMID: 32658298BACKGROUND

  • 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.

    PMID: 33496775BACKGROUND

  • 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.

    PMID: 31019728BACKGROUND

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    PMID: 32003816BACKGROUND

  • 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.

    PMID: 19032513BACKGROUND

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    PMID: 27165047BACKGROUND

  • 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.

    PMID: 7315838BACKGROUND

Related Links

MeSH Terms

Conditions

Chronic DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kris Aubrey-Bassler, MD

    Memorial University of Newfoundland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2022

First Posted

June 21, 2022

Study Start

March 31, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)