HypertensionNCT04791267
ENCOMPASS: Expansion Study C
A study testing Community Health Navigator Program in people with Hypertension and Diabetes Mellitus, Type 2, run by University of Calgary at 1 site in Canada.
Trial summary
Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases
- What is being tested?
- Community Health Navigator Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2021to 28 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poorly controlled hypertension (most recent systolic blood pressure > 160 mmHg or labile);
- Poorly controlled diabetes (A1C > 9% on at least one occasion within the past year or labile);
- Stage 3b or greater chronic kidney disease (estimated glomerular filtration rate < 45 mL/min/1.73m2 in past year);
- Established ischemic heart disease (at least one instance of a physician billing diagnosis with a relevant International Classification of Diseases, 9th Edition [ICD-9] code recorded in electronic medical record (EMR), or known to health care team);
- Congestive heart failure (at least one instance of a physician billing diagnosis with a relevant ICD-9 code recorded in EMR, or known to health care team);
- Chronic obstructive pulmonary disease OR Asthma with at least two visits in the past year (at least 2 instances of a physician billing diagnosis with a relevant ICD-9 code, or known to health care team).
Who cannot join
- Patient unable to provide informed consent;
- Patient residing in long-term care facility;
- Health care provider discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Community Health Through Patient Navigation, Advocacy and Social Support (ENCOMPASS): Expansion Study C, A Randomized Controlled Trial With Waitlist Control
Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Community health navigators (CHNs) are community members who help guide patients through the health care system. CHNs are not health professionals like a doctor or nurse, but they are specially trained to help patients get the most out of their health care and connect them to resources. The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs. To understand if the CHN program can be scaled to a provincial level, the ENCOMPASS program of research is expanding to select primary care settings across Alberta. This study implements and evaluates the CHN program at WestView Primary Care Network in the Greater Edmonton area, Alberta, Canada.
Read the detailed description
Community Health Navigators (CHNs) are defined as community health workers that provide patient navigation. Based on evidence to date, CHNs for chronic disease management are likely to beneficially impact patient experience, clinical outcomes and costs; however, contextual evidence is lacking given that most studies to date have been conducted in the United States. In Canada, patient navigation programs currently exist in only a few settings (primarily cancer treatment and transitional care), with few navigation programs implemented in chronic disease care.
The ENCOMPASS program of research was initiated in 2016, when researchers with the University of Calgary's Interdisciplinary Chronic Disease Collaboration partnered with Mosaic Primary Care Network (PCN) to develop, implement and evaluate a community health navigation program for patients with multiple chronic conditions. The program was based on a systematic literature review and refined in consultation with key stakeholders. A cluster-randomized controlled trial is currently ongoing with Mosaic PCN to determine the impact of the program on acute care use, patient-reported outcomes and experience, and disease-specific clinical outcomes (NCT03077386).
Alberta Primary Care Networks (PCNs) are comprised of groups of family physicians and other health care professionals working together to provide comprehensive patient care to Albertans. To understand if the community health navigation program can be feasibly scaled and spread to PCNs across Alberta, we are expanding research to examine and evaluate community health navigation program implementation to other geographic areas and populations. This study expands the ENCOMPASS program of research to WestView PCN, which represents over 80 physician members. The current study employs the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to examine the scalability of the community health navigation program.
The objectives of this study are to (1) assess the impact of the intervention on the target population and health system (effectiveness); (2) explore the feasibility and appropriateness of practical intervention scale-up (reach, adoption, implementation, and maintenance), and (3) identify the required resources and infrastructure necessary to maintain and scale the intervention provincially.
The effectiveness of the community health navigator program will be studied using a two-armed, pragmatic, randomized waitlist-controlled trial. This study will employ patient-level block randomization with research staff blinded to block size. Randomization will be concealed and computer-generated. Primary outcomes will be assessed using administrative health data. Secondary outcomes will be measured using a patient health survey administered by a research assistant at baseline, 6 months, and 12 months. A concurrent qualitative study will provide contextual information on the effectiveness of the community health navigator program from patient, provider, and CHN perspectives. Process evaluation metrics and interviews with program stakeholders will inform the feasibility and sustainability of the community health navigator program in Alberta PCNs.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Ischemic Heart Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- Being tested
- Community Health Navigator Program
- Keywords
- Chronic Disease, Health Navigation, Health Navigator
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Myocardial Ischemia, Heart Failure, Pulmonary Disease, Chronic Obstructive, Asthma, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Navigator ProgramBehavioural
Also called ENCOMPASS Program
Patients will be matched to a community health navigator (CHN) who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (e.g., social, financial, insurance), helping patients set health-related goals, facilitating health care referrals and appointments, and monitoring appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in-person or over the telephone using motivational interviewing principles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Community health navigator program for six months Receives: Behavioral: Community Health Navigator Program |
| Control | Other | Waitlist control: six-month waiting period followed by six months of community health navigator program Receives: Behavioral: Community Health Navigator Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute care service use
Rate of emergency department visits and hospital admissions based on administrative health data.
Measured: Up to 36 months
Secondary outcomes (25)
Health-related quality of life as assessed by EuroQol EQ-5D-5L
EQ-5D-5L (EuroQol 5 dimension- 5 level instrument) Uses a 5 point scale with higher scores indicating a lower health-related quality of life
Measured: Up to 12 Months
Patient experience of care
11-item modification Patient Assessment of Chronic Illness Care (PACIC) Uses a 0-100% scale with higher percentages indicating a greater assessment of care
Measured: Up to 12 Months
Patient activation
10-item Patient Activation Measure (PAM-10) Uses a 4 point scale with higher scores indicating greater patient activation
Measured: Up to 12 Months
Anxiety symptoms
7-item Generalized Anxiety Disorder (GAD-7) Uses 4 point scale to measure anxiety ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday)
Measured: Up to 12 Months
Depressive symptoms
9-item Patient Health Questionnaire (PHQ-9) Uses a 4 point scale to measure depression ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday)
Measured: Up to 12 Months
Perceived social support
8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS) Uses a 5 point scale with higher scores indicating greater levels of social support
Measured: Up to 12 Months
Health literacy
3-item Brief Screening Questions for Health Literacy Uses a 5 point scale with higher scores indicating lower health literacy
Measured: Up to 12 months
General self-rated health
1-item Self-Rated Health Uses a 4 point scale with higher scores indicating greater self-reported general health
Measured: Up to 12 months
Household food security
6-item Household Food Security Survey Module (HFSSM)
Mix of ordinal and binary variables with affirmative responses being summed and higher scores indicating greater food insecurity
Measured: Up to 12 months
Self-reported Smoking status
Self-reported current smoking status, smoking cessation behaviours, and smoking frequency.
Measured: Up to 12 months
Weight
Change in self-reported weight in kilograms or pounds.
Measured: up to 12 months
Measure of intermediate health outcomes: Diabetes
Change in mean glycosylated hemoglobin (A1C) based on laboratory data.
Measured: Up to 24 months
Measure of intermediate health outcomes: Hypertension
Change in systolic blood pressure (SBP) in mmHg based on primary data collection.
Measured: Up to 12 months
Measure of intermediate health outcomes: Heart Failure
Number of episodes of acutely decompensated heart failure based on administrative health data.
Measured: Up to 24 months
Measure of intermediate health outcomes: COPD/asthma
Number of exacerbations based on administrative health data.
Measured: Up to 24 months
Measure of statin use for patients with ischemic heart disease, chronic kidney disease, diabetes
Appropriate use of statin (where indicated) based on pharmaceutical information network (PIN) dispensation data.
Measured: Up to 24 months
Patient experience
Based on semi-structured interviews.
Measured: Up to 12 months
Provider satisfaction
Based on semi-structured interviews.
Measured: Up to 12 months
Continuity of care
Provider attachment based on Usual Provider of Care (UPC) Index in Alberta practitioners claims file.
Measured: Up to 24 months
Primary Care Network (PCN) multidisciplinary team access
Number of visits to multidisciplinary health team members based on PCN records.
Measured: Up to 24 months
Program costs
Administrative, training, and operational costs of program.
Measured: Up to 24 months
Physician costs
Physician claims based on physician claims files.
Measured: Up to 24 months
Acute care costs
Hospital admission and emergency department visit costs based on administrative health data.
Measured: Up to 24 months
All-cause mortality rate
Rate of all-cause mortality using administrative data.
Measured: Up to 24 months
Medication adherence
≥80% of days covered for medications in Care Plan based on pharmaceutical information network (PIN) dispensation data.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start17 Aug 2021
- Primary completion28 Jan 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The ENCOMPASS study will evaluate the effectiveness of a community health navigator program using a two-armed, pragmatic, randomized waitlist-controlled trial. The intervention arm will receive the CHN program for six months. The waitlist control arm will have a six month waiting period followed by six months of CHN program. This study will employ patient-level block randomization. Research staff will be blinded to block size. In the case where participants live together in the same residence, they will be randomly assigned to the same study arm.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Sponsor
- Investigators
- Kerry A McBrien, MD, MPH, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791267
- Sponsor's protocol ID
- REB20-0340
- Status last verified
- May 2024
- First submitted
- 5 Mar 2021
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 26125243Addressing chronic disease through community health workers: A policy and systems-level approach. Centers for Disease Control and Prevention. 2015.
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.
PubMed 26061832Burns ME, Galbraith AA, Ross-Degnan D, Balaban RB. Feasibility and evaluation of a pilot community health worker intervention to reduce hospital readmissions. Int J Qual Health Care. 2014 Aug;26(4):358-65. doi: 10.1093/intqhc/mzu046. Epub 2014 Apr 16.
PubMed 24744082Enard KR, Ganelin DM. Reducing preventable emergency department utilization and costs by using community health workers as patient navigators. J Healthc Manag. 2013 Nov-Dec;58(6):412-27; discussion 428.
PubMed 24400457Herman 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.
PubMed 17541827Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17.
PubMed 28817334Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):535-43. doi: 10.1001/jamainternmed.2013.14327.
PubMed 24515422Kim 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.
PubMed 26890177Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S. Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):948-954. doi: 10.1001/jamainternmed.2017.0926.
PubMed 28459925Morgan 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.
PubMed 27631747McBrien 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.
PubMed 29462179Ali-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.
PubMed 27771161Walkinshaw 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.
PubMed 21930738
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Community Health Through Patient Navigation, Advocacy and Social Support (ENCOMPASS): Expansion Study C, A Randomized Controlled Trial With Waitlist Control
- ClinicalTrials.gov ID
- NCT04791267
- Acronym / sponsor ID
- REB20-0340
- Conditions
- Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Ischemic Heart Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Disease, Health Navigation, Health Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 10 Mar 2021 (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.
Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Community health navigators (CHNs) are community members who help guide patients through the health care system. CHNs are not health professionals like a doctor or nurse, but they are specially trained to help patients get the most out of their health care and connect them to resources. The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs. To understand if the CHN program can be scaled to a provincial level, the ENCOMPASS program of research is expanding to select primary care settings across Alberta. This study implements and evaluates the CHN program at WestView Primary Care Network in the Greater Edmonton area, Alberta, Canada.
Detailed description
Community Health Navigators (CHNs) are defined as community health workers that provide patient navigation. Based on evidence to date, CHNs for chronic disease management are likely to beneficially impact patient experience, clinical outcomes and costs; however, contextual evidence is lacking given that most studies to date have been conducted in the United States. In Canada, patient navigation programs currently exist in only a few settings (primarily cancer treatment and transitional care), with few navigation programs implemented in chronic disease care.
The ENCOMPASS program of research was initiated in 2016, when researchers with the University of Calgary's Interdisciplinary Chronic Disease Collaboration partnered with Mosaic Primary Care Network (PCN) to develop, implement and evaluate a community health navigation program for patients with multiple chronic conditions. The program was based on a systematic literature review and refined in consultation with key stakeholders. A cluster-randomized controlled trial is currently ongoing with Mosaic PCN to determine the impact of the program on acute care use, patient-reported outcomes and experience, and disease-specific clinical outcomes (NCT03077386).
Alberta Primary Care Networks (PCNs) are comprised of groups of family physicians and other health care professionals working together to provide comprehensive patient care to Albertans. To understand if the community health navigation program can be feasibly scaled and spread to PCNs across Alberta, we are expanding research to examine and evaluate community health navigation program implementation to other geographic areas and populations. This study expands the ENCOMPASS program of research to WestView PCN, which represents over 80 physician members. The current study employs the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to examine the scalability of the community health navigation program.
The objectives of this study are to (1) assess the impact of the intervention on the target population and health system (effectiveness); (2) explore the feasibility and appropriateness of practical intervention scale-up (reach, adoption, implementation, and maintenance), and (3) identify the required resources and infrastructure necessary to maintain and scale the intervention provincially.
The effectiveness of the community health navigator program will be studied using a two-armed, pragmatic, randomized waitlist-controlled trial. This study will employ patient-level block randomization with research staff blinded to block size. Randomization will be concealed and computer-generated. Primary outcomes will be assessed using administrative health data. Secondary outcomes will be measured using a patient health survey administered by a research assistant at baseline, 6 months, and 12 months. A concurrent qualitative study will provide contextual information on the effectiveness of the community health navigator program from patient, provider, and CHN perspectives. Process evaluation metrics and interviews with program stakeholders will inform the feasibility and sustainability of the community health navigator program in Alberta PCNs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The ENCOMPASS study will evaluate the effectiveness of a community health navigator program using a two-armed, pragmatic, randomized waitlist-controlled trial. The intervention arm will receive the CHN program for six months. The waitlist control arm will have a six month waiting period followed by six months of CHN program. This study will employ patient-level block randomization. Research staff will be blinded to block size. In the case where participants live together in the same residence, they will be randomly assigned to the same study arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Community Health Navigator ProgramCommunity health navigator program for six months |
| Control | Other | Behavioral: Community Health Navigator ProgramWaitlist control: six-month waiting period followed by six months of community health navigator program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Poorly controlled hypertension (most recent systolic blood pressure > 160 mmHg or labile);
- Poorly controlled diabetes (A1C > 9% on at least one occasion within the past year or labile);
- Stage 3b or greater chronic kidney disease (estimated glomerular filtration rate < 45 mL/min/1.73m2 in past year);
- Established ischemic heart disease (at least one instance of a physician billing diagnosis with a relevant International Classification of Diseases, 9th Edition [ICD-9] code recorded in electronic medical record (EMR), or known to health care team);
- Congestive heart failure (at least one instance of a physician billing diagnosis with a relevant ICD-9 code recorded in EMR, or known to health care team);
Key exclusion criteria (3 listed)
- Patient unable to provide informed consent;
- Patient residing in long-term care facility;
- Health care provider discretion.
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 |
|---|---|---|
| Community Health Navigator ProgramAlso: ENCOMPASS ProgramPatients will be matched to a community health navigator (CHN) who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (e.g., social, financial, insurance), helping patients set health-related goals, facilitating health care referrals and appointments, and monitoring appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in-person or over the telephone using motivational interviewing principles. | Behavioural | Control, Intervention |
Primary outcome
Acute care service use
Time frame: Up to 36 months
Rate of emergency department visits and hospital admissions based on administrative health data.
25 secondary outcomes
Health-related quality of life as assessed by EuroQol EQ-5D-5L
Time frame: Up to 12 Months
Patient experience of care
Time frame: Up to 12 Months
Patient activation
Time frame: Up to 12 Months
Anxiety symptoms
Time frame: Up to 12 Months
Depressive symptoms
Time frame: Up to 12 Months
Perceived social support
Time frame: Up to 12 Months
Health literacy
Time frame: Up to 12 months
General self-rated health
Time frame: Up to 12 months
Household food security
Time frame: Up to 12 months
Self-reported Smoking status
Time frame: Up to 12 months
Weight
Time frame: up to 12 months
Measure of intermediate health outcomes: Diabetes
Time frame: Up to 24 months
Measure of intermediate health outcomes: Hypertension
Time frame: Up to 12 months
Measure of intermediate health outcomes: Heart Failure
Time frame: Up to 24 months
Measure of intermediate health outcomes: COPD/asthma
Time frame: Up to 24 months
Measure of statin use for patients with ischemic heart disease, chronic kidney disease, diabetes
Time frame: Up to 24 months
Patient experience
Time frame: Up to 12 months
Provider satisfaction
Time frame: Up to 12 months
Continuity of care
Time frame: Up to 24 months
Primary Care Network (PCN) multidisciplinary team access
Time frame: Up to 24 months
Program costs
Time frame: Up to 24 months
Physician costs
Time frame: Up to 24 months
Acute care costs
Time frame: Up to 24 months
All-cause mortality rate
Time frame: Up to 24 months
Medication adherence
Time frame: Up to 24 months
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 23 May 2024.
- BackgroundLehmann 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.
- Background: PubMed 26125243Najafizada 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.
- BackgroundAddressing chronic disease through community health workers: A policy and systems-level approach. Centers for Disease Control and Prevention. 2015.
- Background: PubMed 26061832Kangovi 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.
- Background: PubMed 24744082Burns ME, Galbraith AA, Ross-Degnan D, Balaban RB. Feasibility and evaluation of a pilot community health worker intervention to reduce hospital readmissions. Int J Qual Health Care. 2014 Aug;26(4):358-65. doi: 10.1093/intqhc/mzu046. Epub 2014 Apr 16.
- Background: PubMed 24400457Enard KR, Ganelin DM. Reducing preventable emergency department utilization and costs by using community health workers as patient navigators. J Healthc Manag. 2013 Nov-Dec;58(6):412-27; discussion 428.
- Background: PubMed 17541827Herman 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.
- Background: PubMed 28817334Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17.
- Background: PubMed 24515422Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):535-43. doi: 10.1001/jamainternmed.2013.14327.
- Background: PubMed 26890177Kim 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.
- Background: PubMed 28459925Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S. Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):948-954. doi: 10.1001/jamainternmed.2017.0926.
- Background: PubMed 27631747Morgan 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.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
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.
Kerry A McBrien, MD, MPH principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Navigator Program in people with Hypertension and Diabetes Mellitus, Type 2, run by University of Calgary 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 6 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 23 May 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?
Acute care service use (time frame: Up to 36 months). 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 NCT04791267, which also lists 17 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 23 May 2024.