Delivery Modality of BETTER InterventionNCT05425797
The Virtual BETTER Study
A study testing In-Person Prevention Practitioner Visit, Video-Call Prevention Practitioner Visit and Phone Prevention Practitioner Visit in people with Delivery Modality of BETTER Intervention, run by Memorial University of Newfoundland at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Delivery Modality of BETTER Intervention
- What is being tested?
- In-Person Prevention Practitioner Visit, Video-Call Prevention Practitioner Visit and Phone Prevention Practitioner Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons aged 40-70
- Persons who are already booking a BETTER prevention visit.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B3V6
About this study
Official title: 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).
Read the 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).
- Conditions
- Delivery Modality of BETTER Intervention
- Being tested
- In-Person Prevention Practitioner Visit, Video-Call Prevention Practitioner Visit, Phone Prevention Practitioner Visit
- Keywords
- chronic disease, lifestyle, screening, physical activity, diet
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Prevention Practitioner VisitOther
BETTER Intervention visit with PP which will take place in-person at the PP's office.
Video-Call Prevention Practitioner VisitOther
BETTER Intervention visit with PP which will take place virtually via a secure video system.
Phone Prevention Practitioner VisitOther
BETTER Intervention visit with PP which will take place via telephone.
| Study group | Role | What they receive |
|---|---|---|
| In-Person | Active comparator | Standard Prevention Practitioner visit that will take place in-person Receives: Other: In-Person Prevention Practitioner Visit |
| Video | Experimental | Prevention Practitioner visit that will take place through video call Receives: Other: Video-Call Prevention Practitioner Visit |
| Phone | Experimental | Prevention Practitioner visit that will take place through phone call Receives: Other: Phone Prevention Practitioner Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post-Visit (less than 1 week after visit)
Secondary outcomes (3)
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)
Measured: Post-Visit (less than 1 week after visit)
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)
Measured: Enrollment (Pre-visit)
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)
Measured: Enrollment (Pre-visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start31 Mar 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Delivery Modality of BETTER InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kris Aubrey-Bassler, Memorial University of Newfoundland
- Investigators
- Kris Aubrey-Bassler, MD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425797
- Sponsor's protocol ID
- CIHRVirtualBETTER
- Status last verified
- Nov 2024
- First submitted
- 12 May 2022
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16418496Grunfeld 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.
PubMed 22042959Boekhout 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.
PubMed 25896265Elmslie K. Against the Growing Burden of Disease. Ottawa, ON: Public Health Agency of Canada.
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.
PubMed 24252125Yarnall 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.
PubMed 12660210Grol 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.
PubMed 11583121Campbell-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.
PubMed 25077119Tobe 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.
PubMed 21911548Mair 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.
PubMed 10834899Whitten 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.
PubMed 16388172Bully 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.
PubMed 25572619Grunfeld 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.
PubMed 22972732Pronk 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.
PubMed 15275669Coburn 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.
PubMed 26431861
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Primary Care Virtually: the Virtual BETTER Study
- ClinicalTrials.gov ID
- NCT05425797
- Acronym / sponsor ID
- CIHRVirtualBETTER
- Conditions
- Delivery Modality of BETTER Intervention
- Keywords
- chronic disease, lifestyle, screening, physical activity, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-Person | Active comparator | Other: In-Person Prevention Practitioner VisitStandard Prevention Practitioner visit that will take place in-person |
| Video | Experimental | Other: Video-Call Prevention Practitioner VisitPrevention Practitioner visit that will take place through video call |
| Phone | Experimental | Other: Phone Prevention Practitioner VisitPrevention Practitioner visit that will take place through phone call |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons aged 40-70
- Persons who are already booking a BETTER prevention visit.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Prevention Practitioner VisitBETTER Intervention visit with PP which will take place in-person at the PP's office. | Other | In-Person |
| Video-Call Prevention Practitioner VisitBETTER Intervention visit with PP which will take place virtually via a secure video system. | Other | Video |
| Phone Prevention Practitioner VisitBETTER Intervention visit with PP which will take place via telephone. | Other | Phone |
Primary outcome
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)
3 secondary outcomes
Satisfaction of Modalities (Client Satisfaction Questionnaire: CSQ-4)
Time frame: Post-Visit (less than 1 week after visit)
Acceptability
Time frame: Enrollment (Pre-visit)
Accessibility
Time frame: Enrollment (Pre-visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 16418496Grunfeld 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.
- Background: PubMed 22042959Grunfeld 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.
- Background: PubMed 25896265Boekhout 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.
- BackgroundElmslie K. Against the Growing Burden of Disease. Ottawa, ON: Public Health Agency of Canada.
- Background: PubMed 24252125Grunfeld 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.
- Background: PubMed 12660210Yarnall 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.
- Background: PubMed 11583121Grol 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.
- Background: PubMed 25077119Campbell-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.
- Background: PubMed 21911548Tobe 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.
- Background: PubMed 10834899Mair 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.
- Background: PubMed 16388172Whitten 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.
- Background: PubMed 25572619Bully 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.
- link to pubmed abstract for this pmid 16418496Link provided by the sponsor.
- link to pubmed abstract for this pmid 22042959Link provided by the sponsor.
- link to pubmed abstract for this pmid 25896265Link provided by the sponsor.
- link to pubmed abstract for this pmid 24252125Link provided by the sponsor.
- link to pubmed abstract for this pmid 12660210Link provided by the sponsor.
- link to pubmed abstract for this pmid 11583121Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Aubrey-Bassler, MD principal investigator
Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Prevention Practitioner Visit, Video-Call Prevention Practitioner Visit and Phone Prevention Practitioner Visit in people with Delivery Modality of BETTER Intervention, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness to Change (University of Rhode Island Change Assessment Scale: URICA) (time frame: Post-Visit (less than 1 week after visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05425797, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.