Study Summary
This trial is testing a program that uses community health navigators to help patients with multiple long-term health conditions get the care and resources they need.
Eligible Conditions
- Coronary Artery Disease
- Asthma
- Congestive Heart Failure
- Chronic Obstructive Pulmonary Disease (COPD)
- Type 2 Diabetes
- Chronic Kidney Disease
- High Blood Pressure
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 33 Secondary · Reporting Duration: Up to 36 months
Up to 12 Months
Anxiety symptoms
Depressive symptoms
Health-related quality of life
Health-related quality of life as assessed by EuroQol EQ-5D-5L
Patient activation
Patient experience of care
Perceived social support
Up to 12 months
Disease-specific intermediate health outcomes: Hypertension
General self-rated health
Health literacy
Household food security
Measure of intermediate health outcomes: Hypertension
Patient experience
Provider satisfaction
Self-reported Smoking status
Smoking status
Up to 24 months
Acute care costs
All-cause mortality
All-cause mortality rate
Continuity of care
Disease-specific intermediate health outcomes: COPD/asthma
Disease-specific intermediate health outcomes: Diabetes
Heart failure
Disease-specific intermediate health outcomes: Ischemic heart disease, chronic kidney disease, diabetes
Measure of intermediate health outcomes: COPD/asthma
Measure of intermediate health outcomes: Diabetes
Measure of intermediate health outcomes: Heart Failure
Measure of statin use for patients with ischemic heart disease, chronic kidney disease, diabetes
Medication adherence
Physician costs
Primary Care Network (PCN) multidisciplinary team access
Program costs
Up to 36 months
Acute care service use
up to 12 months
Weight
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Intervention
1 of 1
Experimental Treatment
61 Total Participants · 1 Treatment Group
Primary Treatment: Community Health Navigator Program · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: Community Health Navigator Program · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
Who is running the clinical trial?
University of AlbertaOTHER
838 Previous Clinical Trials
386,679 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
19,284 Patients Enrolled for Coronary Artery Disease
University of CalgaryLead Sponsor
727 Previous Clinical Trials
573,517 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
10,535 Patients Enrolled for Coronary Artery Disease
Kerry A McBrien, MD, MPHPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
455 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
455 Patients Enrolled for Coronary Artery Disease
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Walkinshaw, Erin. 2011. “Patient Navigators Becoming the Norm in Canada”. Canadian Medical Association Journal. CMA Joule Inc.. doi:10.1503/cmaj.109-3974.
- Burns, M. E., A. A. Galbraith, D. Ross-Degnan, and R. B. Balaban. 2014. “Feasibility and Evaluation of a Pilot Community Health Worker Intervention to Reduce Hospital Readmissions”. International Journal for Quality in Health Care. Oxford University Press (OUP). doi:10.1093/intqhc/mzu046.
- Najafizada, Said Ahmad Maisam, Ivy Lynn Bourgeault, Ronald Labonte, Corinne Packer, and Sara Torres. 2015. “Community Health Workers in Canada and Other High-income Countries: A Scoping Review and Research Gaps”. Canadian Journal of Public Health. Springer Science and Business Media LLC. doi:10.17269/cjph.106.4747.
- Herman, Daniel, Sarah Conover, Alan Felix, Aman Nakagawa, and Danika Mills. 2007. “Critical Time Intervention: An Empirically Supported Model for Preventing Homelessness in High Risk Groups”. The Journal of Primary Prevention. Springer Science and Business Media LLC. doi:10.1007/s10935-007-0099-3.
- Kim, Kyounghae, Janet S. Choi, Eunsuk Choi, Carrie L. Nieman, Jin Hui Joo, Frank R. Lin, Laura N. Gitlin, and Hae-Ra Han. 2016. “Effects of Community-based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2015.302987.
- Carrasquillo, Olveen, Cynthia Lebron, Yisel Alonzo, Hua Li, Aileen Chang, and Sonjia Kenya. 2017. “Effect of a Community Health Worker Intervention Among Latinos with Poorly Controlled Type 2 Diabetes”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2017.0926.
- Seaberg, David, Stanton Elseroad, Michael Dumas, Sudave Mendiratta, Jessica Whittle, Cheryl Hyatte, and Jan Keys. 2017. “Patient Navigation for Patients Frequently Visiting the Emergency Department: A Randomized, Controlled Trial”. Edited by Alice M. Mitchell. Academic Emergency Medicine. Wiley. doi:10.1111/acem.13280.
- Kangovi, Shreya, Nandita Mitra, David Grande, Hairong Huo, Robyn A. Smith, and Judith A. Long. 2017. “Community Health Worker Support for Disadvantaged Patients with Multiple Chronic Diseases: A Randomized Clinical Trial”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2017.303985.
- Ali-Faisal, Sobia F., Tracey J.F. Colella, Naomi Medina-Jaudes, and Lisa Benz Scott. 2017. “The Effectiveness of Patient Navigation to Improve Healthcare Utilization Outcomes: A Meta-analysis of Randomized Controlled Trials”. Patient Education and Counseling. Elsevier BV. doi:10.1016/j.pec.2016.10.014.
- Kangovi, Shreya, David Grande, and Chau Trinh-Shevrin. 2015. “From Rhetoric to Reality — Community Health Workers in Post-reform U.S. Health Care”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmp1502569.
- Kangovi, Shreya, Nandita Mitra, David Grande, Mary L. White, Sharon McCollum, Jeffrey Sellman, Richard P. Shannon, and Judith A. Long. 2014. “Patient-centered Community Health Worker Intervention to Improve Posthospital Outcomes”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2013.14327.
- Morgan, Anna U., David T. Grande, Tamala Carter, Judith A. Long, and Shreya Kangovi. 2016. “Penn Center for Community Health Workers: Step-by-step Approach to Sustain an Evidence-based Community Health Worker Intervention at an Academic Medical Center”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2016.303366.
- McBrien, Kerry A., Noah Ivers, Lianne Barnieh, Jacob J. Bailey, Diane L. Lorenzetti, David Nicholas, Marcello Tonelli, et al.. 2018. “Patient Navigators for People with Chronic Disease: A Systematic Review”. Edited by Jacobus P. van Wouwe. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0191980.
- Desveaux, Laura, Kerry McBrien, Lianne Barnieh, and Noah M. Ivers. 2019. “Mapping Variation in Intervention Design: A Systematic Review to Develop a Program Theory for Patient Navigator Programs”. Systematic Reviews. Springer Science and Business Media LLC. doi:10.1186/s13643-018-0920-5.
- Shommu, Nusrat Sharmeen, Salim Ahmed, Nahid Rumana, Gary R. S. Barron, Kerry Alison McBrien, and Tanvir Chowdhury Turin. 2016. “What Is the Scope of Improving Immigrant and Ethnic Minority Healthcare Using Community Navigators: A Systematic Scoping Review”. International Journal for Equity in Health. Springer Science and Business Media LLC. doi:10.1186/s12939-016-0298-8.
- Kangovi, Shreya, Nandita Mitra, David Grande, Hairong Huo, Robyn A. Smith, and Judith A. Long. 2017. “Community Health Worker Support for Disadvantaged Patients with Multiple Chronic Diseases: A Randomized Clinical Trial”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2017.303985.
- Carrasquillo, Olveen, Cynthia Lebron, Yisel Alonzo, Hua Li, Aileen Chang, and Sonjia Kenya. 2017. “Effect of a Community Health Worker Intervention Among Latinos with Poorly Controlled Type 2 Diabetes”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2017.0926.
- Lehmann U, Sanders, D. Community health workers: What do we know about them? The state of the evidence on programmes, activities, costs an impact on health outcomes of Using community health workers. Geneva: World Health Organization. 2007.
- Addressing chronic disease through community health workers: A policy and systems-level approach. Centers for Disease Control and Prevention. 2015.
- Walkinshaw E. Patient navigators becoming the norm in Canada. CMAJ. 2011 Oct 18;183(15):E1109-10. doi: 10.1503/cmaj.109-3974. Epub 2011 Sep 19. No abstract available.
- Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
- Herman D, Conover S, Felix A, Nakagawa A, Mills D. Critical Time Intervention: an empirically supported model for preventing homelessness in high risk groups. J Prim Prev. 2007 Jul;28(3-4):295-312. doi: 10.1007/s10935-007-0099-3. Epub 2007 Jun 1.
- Shommu NS, Ahmed S, Rumana N, Barron GR, McBrien KA, Turin TC. What is the scope of improving immigrant and ethnic minority healthcare using community navigators: A systematic scoping review. Int J Equity Health. 2016 Jan 15;15:6. doi: 10.1186/s12939-016-0298-8.
- McBrien KA, Ivers N, Barnieh L, Bailey JJ, Lorenzetti DL, Nicholas D, Tonelli M, Hemmelgarn B, Lewanczuk R, Edwards A, Braun T, Manns B. Patient navigators for people with chronic disease: A systematic review. PLoS One. 2018 Feb 20;13(2):e0191980. doi: 10.1371/journal.pone.0191980. eCollection 2018.
- Morgan AU, Grande DT, Carter T, Long JA, Kangovi S. Penn Center for Community Health Workers: Step-by-Step Approach to Sustain an Evidence-Based Community Health Worker Intervention at an Academic Medical Center. Am J Public Health. 2016 Nov;106(11):1958-1960. doi: 10.2105/AJPH.2016.303366. Epub 2016 Sep 15.
- Najafizada SA, Bourgeault IL, Labonte R, Packer C, Torres S. Community health workers in Canada and other high-income countries: A scoping review and research gaps. Can J Public Health. 2015 Mar 12;106(3):e157-64. doi: 10.17269/cjph.106.4747.
- Ali-Faisal SF, Colella TJ, Medina-Jaudes N, Benz Scott L. The effectiveness of patient navigation to improve healthcare utilization outcomes: A meta-analysis of randomized controlled trials. Patient Educ Couns. 2017 Mar;100(3):436-448. doi: 10.1016/j.pec.2016.10.014. Epub 2016 Oct 17.
- Kangovi S, Grande D, Trinh-Shevrin C. From rhetoric to reality--community health workers in post-reform U.S. health care. N Engl J Med. 2015 Jun 11;372(24):2277-9. doi: 10.1056/NEJMp1502569. No abstract available.
- 2021. "ENCOMPASS: Expansion Study C". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04791267.
Frequently Asked Questions
Is this medical investigation currently accepting participants?
"Per the information on clinicaltrials.gov, recruitment for this medical trial is ongoing. It was originally posted on April 1st of 2021 and its most recent update occurred on May 19th of 2022." - Anonymous Online Contributor
Unverified Answer
What is the current participant count for this clinical trial?
"Affirmative. According to the clinicaltrials.gov site, this research study is actively recruiting participants since its inception on April 1st 2021 and last amendment on May 19th 2022. The team seeks two hundred individuals from a single medical centre for the trial's duration." - Anonymous Online Contributor
Unverified Answer