HypertensionENCOMPASSNCT03077386
Enhancing Community Health Through Patient Navigation, Advocacy and Social Support
A study testing ENCOMPASS Intervention in people with Hypertension and Diabetes Mellitus, Type 2, run by University of Calgary at 1 site in Canada.
Trial summary
Some patients who have multiple long-term health conditions have significant challenges accessing needed services despite available primary care and social services resources. Patient navigation programs may help those with complex health conditions improve their care and outcomes and if delivered by community health… 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?
- ENCOMPASS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2018to 3 Mar 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
- ≥ 18 years of age with two or more of the following:
- Poorly controlled hypertension (most recent systolic blood pressure > 160 mmHg);
- Poorly controlled diabetes (A1C > 9% on at least one occasion within the past year);
- 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 a long-term care facility;
- physician discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Some patients who have multiple long-term health conditions have significant challenges accessing needed services despite available primary care and social services resources. Patient navigation programs may help those with complex health conditions improve their care and outcomes and if delivered by community health navigators (CHNs) who have close community ties, these programs have the potential to reduce barriers to care and increase access to coordinated, person-centred care. The ENCOMPASS program aims to improve the care and health outcomes for high-risk patients by linking patients with chronic disease with a CHN to help them navigate the health system, facilitate communication between patients and providers, improve patients' understanding of their conditions and treatment plans, and support patients in their self-management. In Canada, patient navigation programs have not been well studied or broadly implemented in patients with chronic disease, making a comprehensive evaluation of ENCOMPASS important. This program has great potential to improve care for patients with chronic diseases in primary care.
Read the detailed description
Although non-communicable chronic disease is the leading cause of death in Canada, many patients with chronic diseases do not receive guideline-recommended therapy for a variety of reasons. Lack of awareness of publicly funded programs, financial constraints, personal circumstances, language and cultural barriers make it challenging for patients to follow recommendations. ENCOMPASS is a patient navigation intervention, delivered by community health navigators (CHNs), that will improve patient-centred care and outcomes by: helping patients navigate the health system, facilitating communication between patients and providers, improving patient understanding of their conditions and treatment plans, connecting patients with community resources and supporting patient self-management.
The ENCOMPASS intervention is based on an extensive literature review, and was refined in consultation with patients, operational partners, front-line care providers, and local and provincial policy makers. A pilot study has informed implementation, recruitment and data collection methods. This study will implement and test the intervention using a pragmatic cluster-randomized trial with a concurrent qualitative study. The objectives of this study are to determine the effectiveness of patient navigation, delivered by CHNs, in patients with multiple chronic diseases on: a) emergency department visits and hospital admissions over 12 months (primary outcome), b) patient-reported outcome and experience measures, and c) disease-specific clinical outcomes, compared with usual care. Additional objectives focus on practical aspects including understanding the experience of care from the patient and CHN perspective and factors influencing the intervention's ability to improve care and outcomes.
The effectiveness of ENCOMPASS will be studied using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial (cRCT) in 16 clusters, with a target size of 1600 patients with chronic disease. If additional funding is realized the trial will be expanded to include additional clusters. Primary care practices with ~5 full-time physicians will be the cluster units and small practices of 2-3 physicians may be combined into one cluster. Half of the clusters will be randomized to receive the program immediately (Early Phase clusters), while the other half will be required to wait 6 months (Late Phase clusters). Randomization will be concealed, computer-generated and stratified by practice size. Although patients and providers cannot be blinded to the intervention, end-point evaluation will be blinded. The primary outcome will be assessed using administrative health data, eliminating risk of assessor bias. Control patients will receive usual care until the intervention is implemented in their clinic, at which time they will be eligible for the ENCOMPASS program.
Patients will meet with a research assistant at baseline, 6 and 12 months, with an additional 18 month follow-up for control patients, to assess clinical data, including weight, blood pressure, and patient-reported measures. Other endpoints (i.e., through administrative and laboratory data) will be assessed at 6, 12, and 24 months. Once implemented, the ENCOMPASS program will remain available to clinic patients until the end of the program funding period, which may be extended subject to budget decisions and preliminary results. A concurrent qualitative study will provide contextual information and will be used to make program refinements in the Late Phase, the impacts of which will be explored in a comparative analysis.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Ischemic Heart Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- Being tested
- ENCOMPASS Intervention
- Keywords
- patient navigator, community health navigator, multi-morbidity, primary care, social determinants of health
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Myocardial Ischemia, Heart Failure, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENCOMPASS InterventionBehavioural
Also called Community Health Navigation Services
Patients will be matched to a 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 (i.e., social, financial, insurance), helping patients set health related goals, liaising with a patient's employer, facilitating health care referrals and appointments, monitoring appointments, and facilitating transportation to 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 |
|---|---|---|
| ENCOMPASS program | Experimental | Clinics assigned to the intervention will receive the ENCOMPASS intervention and a CHN will be matched to their clinic and be available to patients that meet the eligibility criteria. Receives: Behavioral: ENCOMPASS Intervention |
| Usual care | No intervention | Patients not enrolled in the intervention will continue to receive care as usual until their clinic receives the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute care utilization
All emergency department visits and hospital admissions
Measured: Up to 36 months
Secondary outcomes (20)
Health-related quality of life
EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration
Measured: Up to 24 months
Disease-specific intermediate health outcomes (hypertension)
Blood pressure based on primary data collection
Measured: Up to 24 months
Disease-specific intermediate health outcomes (diabetes)
Hemoglobin A1c based on laboratory data
Measured: Up to 24 months
Disease-specific intermediate health outcomes (appropriate medication use)
Use of a statin where indicated (according to chronic disease guidelines)
Measured: Up to 24 months
Disease-specific intermediate health outcomes (heart failure)
Number exacerbations based on administrative data
Measured: Up to 24 months
Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma)
Number exacerbation based on administrative data
Measured: Up to 24 months
Patient activation
Patient activation measure (PAM) administration via survey questionnaire
Measured: Up to 24 months
Patient experience with chronic illness care
Patient assessment of chronic illness care (PACIC) administration via survey questionnaire
Measured: Up to 24 months
Primary care attachment
Usual provider of care index (UPC) based on physician claims data
Measured: Up to 24 months
Physician experience
Open-ended questions via semi-structured interview
Measured: 6- and 12-months post-implementation
Medication adherence
Pharmaceutical information network (PIN) administrative data
Measured: Up to 24 months
Mortality
All-cause mortality based on administrative data
Measured: Up to 24 months
Weight
Weight based on primary data collection
Measured: Up to 24 months
Social support
Social support based on Medical Outcomes Study Social Support Survey
Measured: Up to 24 months
Smoking status
Current smoker Yes/No
Measured: Up to 24 months
Depression score
Patient Health Questionnaire - 9 item administration via survey questionnaire (PHQ-9). 4 point scale to measure depression ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday).
Measured: Up to 24 months
Anxiety score
Generalized Anxiety Disorder - 7 item administration via survey questionnaire (GAD-7). 4 point scale to measure anxiety ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday).
Measured: Up to 24 months
Program costs
Total operational costs
Measured: Up to 24 months
Physician costs
Physician claims costs
Measured: Up to 24 months
Acute care costs
Costs for emergency department visits and hospital admissions, based on RIW methods
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 posted13 Mar 2017
- Study start8 Jun 2018
- Primary completion3 Mar 2023
- Study completion3 Mar 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 HypertensionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 investigators will test the effectiveness of the ENCOMPASS program using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial. Half the clinics will be randomized to receive the intervention immediately, serving as the intervention group, while the other half will receive the intervention after a 6 month waiting period, acting as control sites during their first 6 months. Once implemented, the ENCOMPASS program will remain available to clinics until the end of the funding period. Control patients will continue to receive usual care until their clinic becomes eligible for the program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Canadian Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Kerry A McBrien, MD, MPH, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077386
- Sponsor's protocol ID
- REB17-0360
- Acronym
- ENCOMPASS
- Status last verified
- May 2024
- First submitted
- 1 Mar 2017
- 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
Public Health Agency of Canada. Chronic Disease and Injury Framework Quick Stats, 2016 Edition. Retreived from http://www.phac-aspc.gc.ca/publicat/hpcdp-pspmc/36-8/assets/pdf/ar-04-eng.pdf
Saher, MN (2014). Report of the Auditor General of Alberta: Health- Chronic Disease Management. Edmonton, AB: Office of the Auditor General of Alberta.
Fortin M, Bravo G, Hudon C, Vanasse A, Lapointe L. Prevalence of multimorbidity among adults seen in family practice. Ann Fam Med. 2005 May-Jun;3(3):223-8. doi: 10.1370/afm.272.
PubMed 15928225Bayliss EA, Bayliss MS, Ware JE Jr, Steiner JF. Predicting declines in physical function in persons with multiple chronic medical conditions: what we can learn from the medical problem list. Health Qual Life Outcomes. 2004 Sep 7;2:47. doi: 10.1186/1477-7525-2-47.
PubMed 15353000Condelius A, Edberg AK, Jakobsson U, Hallberg IR. Hospital admissions among people 65+ related to multimorbidity, municipal and outpatient care. Arch Gerontol Geriatr. 2008 Jan-Feb;46(1):41-55. doi: 10.1016/j.archger.2007.02.005. Epub 2007 Apr 2.
PubMed 17403548Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51.
PubMed 15380021Manns BJ, Tonelli M, Zhang J, Campbell DJ, Sargious P, Ayyalasomayajula B, Clement F, Johnson JA, Laupacis A, Lewanczuk R, McBrien K, Hemmelgarn BR. Enrolment in primary care networks: impact on outcomes and processes of care for patients with diabetes. CMAJ. 2012 Feb 7;184(2):E144-52. doi: 10.1503/cmaj.110755. Epub 2011 Dec 5.
PubMed 22143232McAlister FA, Majumdar SR, Eurich DT, Johnson JA. The effect of specialist care within the first year on subsequent outcomes in 24,232 adults with new-onset diabetes mellitus: population-based cohort study. Qual Saf Health Care. 2007 Feb;16(1):6-11. doi: 10.1136/qshc.2006.018648.
PubMed 17301194Shah BR, Hux JE, Austin PC. Diabetes is not treated as a coronary artery disease risk equivalent. Diabetes Care. 2007 Feb;30(2):381-3. doi: 10.2337/dc06-1654. No abstract available.
PubMed 17259516Sirois C, Moisan J, Poirier P, Gregoire JP. Suboptimal use of cardioprotective drugs in newly treated elderly individuals with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1880-2. doi: 10.2337/dc06-2257. Epub 2007 Mar 23. No abstract available.
PubMed 17384345Supina AL, Guirguis LM, Majumdar SR, Lewanczuk RZ, Lee TK, Toth EL, Johnson JA. Treatment gaps for hypertension management in rural Canadian patients with type 2 diabetes mellitus. Clin Ther. 2004 Apr;26(4):598-606. doi: 10.1016/s0149-2918(04)90062-8.
PubMed 15189757Tonelli M, Bohm C, Pandeya S, Gill J, Levin A, Kiberd BA. Cardiac risk factors and the use of cardioprotective medications in patients with chronic renal insufficiency. Am J Kidney Dis. 2001 Mar;37(3):484-9.
PubMed 11228171Tonelli M, Gill J, Pandeya S, Bohm C, Levin A, Kiberd BA. Barriers to blood pressure control and angiotensin enzyme inhibitor use in Canadian patients with chronic renal insufficiency. Nephrol Dial Transplant. 2002 Aug;17(8):1426-33. doi: 10.1093/ndt/17.8.1426.
PubMed 12147790Toth EL, Majumdar SR, Guirguis LM, Lewanczuk RZ, Lee TK, Johnson JA. Compliance with clinical practice guidelines for type 2 diabetes in rural patients: treatment gaps and opportunities for improvement. Pharmacotherapy. 2003 May;23(5):659-65. doi: 10.1592/phco.23.5.659.32203.
PubMed 12741441Ronksley PE, Sanmartin C, Campbell DJ, Weaver RG, Allan GM, McBrien KA, Tonelli M, Manns BJ, Hennessy D, Hemmelgarn BR. Perceived barriers to primary care among western Canadians with chronic conditions. Health Rep. 2014 Apr;25(4):3-10.
PubMed 24744042
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
- ClinicalTrials.gov ID
- NCT03077386
- Acronym / sponsor ID
- ENCOMPASS / REB17-0360
- Conditions
- Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Ischemic Heart Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- Keywords
- patient navigator, community health navigator, multi-morbidity, primary care, social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Canadian Diabetes Association
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 13 Mar 2017 (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 who have multiple long-term health conditions have significant challenges accessing needed services despite available primary care and social services resources. Patient navigation programs may help those with complex health conditions improve their care and outcomes and if delivered by community health navigators (CHNs) who have close community ties, these programs have the potential to reduce barriers to care and increase access to coordinated, person-centred care. The ENCOMPASS program aims to improve the care and health outcomes for high-risk patients by linking patients with chronic disease with a CHN to help them navigate the health system, facilitate communication between patients and providers, improve patients' understanding of their conditions and treatment plans, and support patients in their self-management. In Canada, patient navigation programs have not been well studied or broadly implemented in patients with chronic disease, making a comprehensive evaluation of ENCOMPASS important. This program has great potential to improve care for patients with chronic diseases in primary care.
Detailed description
Although non-communicable chronic disease is the leading cause of death in Canada, many patients with chronic diseases do not receive guideline-recommended therapy for a variety of reasons. Lack of awareness of publicly funded programs, financial constraints, personal circumstances, language and cultural barriers make it challenging for patients to follow recommendations. ENCOMPASS is a patient navigation intervention, delivered by community health navigators (CHNs), that will improve patient-centred care and outcomes by: helping patients navigate the health system, facilitating communication between patients and providers, improving patient understanding of their conditions and treatment plans, connecting patients with community resources and supporting patient self-management.
The ENCOMPASS intervention is based on an extensive literature review, and was refined in consultation with patients, operational partners, front-line care providers, and local and provincial policy makers. A pilot study has informed implementation, recruitment and data collection methods. This study will implement and test the intervention using a pragmatic cluster-randomized trial with a concurrent qualitative study. The objectives of this study are to determine the effectiveness of patient navigation, delivered by CHNs, in patients with multiple chronic diseases on: a) emergency department visits and hospital admissions over 12 months (primary outcome), b) patient-reported outcome and experience measures, and c) disease-specific clinical outcomes, compared with usual care. Additional objectives focus on practical aspects including understanding the experience of care from the patient and CHN perspective and factors influencing the intervention's ability to improve care and outcomes.
The effectiveness of ENCOMPASS will be studied using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial (cRCT) in 16 clusters, with a target size of 1600 patients with chronic disease. If additional funding is realized the trial will be expanded to include additional clusters. Primary care practices with ~5 full-time physicians will be the cluster units and small practices of 2-3 physicians may be combined into one cluster. Half of the clusters will be randomized to receive the program immediately (Early Phase clusters), while the other half will be required to wait 6 months (Late Phase clusters). Randomization will be concealed, computer-generated and stratified by practice size. Although patients and providers cannot be blinded to the intervention, end-point evaluation will be blinded. The primary outcome will be assessed using administrative health data, eliminating risk of assessor bias. Control patients will receive usual care until the intervention is implemented in their clinic, at which time they will be eligible for the ENCOMPASS program.
Patients will meet with a research assistant at baseline, 6 and 12 months, with an additional 18 month follow-up for control patients, to assess clinical data, including weight, blood pressure, and patient-reported measures. Other endpoints (i.e., through administrative and laboratory data) will be assessed at 6, 12, and 24 months. Once implemented, the ENCOMPASS program will remain available to clinic patients until the end of the program funding period, which may be extended subject to budget decisions and preliminary results. A concurrent qualitative study will provide contextual information and will be used to make program refinements in the Late Phase, the impacts of which will be explored in a comparative analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will test the effectiveness of the ENCOMPASS program using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial. Half the clinics will be randomized to receive the intervention immediately, serving as the intervention group, while the other half will receive the intervention after a 6 month waiting period, acting as control sites during their first 6 months. Once implemented, the ENCOMPASS program will remain available to clinics until the end of the funding period. Control patients will continue to receive usual care until their clinic becomes eligible for the program.
| Arm | Type | Receives |
|---|---|---|
| ENCOMPASS program | Experimental | Behavioral: ENCOMPASS InterventionClinics assigned to the intervention will receive the ENCOMPASS intervention and a CHN will be matched to their clinic and be available to patients that meet the eligibility criteria. |
| Usual care | No intervention | –Patients not enrolled in the intervention will continue to receive care as usual until their clinic receives the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Poorly controlled hypertension (most recent systolic blood pressure > 160 mmHg);
- Poorly controlled diabetes (A1C > 9% on at least one occasion within the past year);
- 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 a long-term care facility;
- physician 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 |
|---|---|---|
| ENCOMPASS InterventionAlso: Community Health Navigation ServicesPatients will be matched to a 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 (i.e., social, financial, insurance), helping patients set health related goals, liaising with a patient's employer, facilitating health care referrals and appointments, monitoring appointments, and facilitating transportation to 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 | ENCOMPASS program |
Primary outcome
Acute care utilization
Time frame: Up to 36 months
All emergency department visits and hospital admissions
20 secondary outcomes
Health-related quality of life
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (hypertension)
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (diabetes)
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (appropriate medication use)
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (heart failure)
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma)
Time frame: Up to 24 months
Patient activation
Time frame: Up to 24 months
Patient experience with chronic illness care
Time frame: Up to 24 months
Primary care attachment
Time frame: Up to 24 months
Physician experience
Time frame: 6- and 12-months post-implementation
Medication adherence
Time frame: Up to 24 months
Mortality
Time frame: Up to 24 months
Weight
Time frame: Up to 24 months
Social support
Time frame: Up to 24 months
Smoking status
Time frame: Up to 24 months
Depression score
Time frame: Up to 24 months
Anxiety score
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
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.
- BackgroundPublic Health Agency of Canada. Chronic Disease and Injury Framework Quick Stats, 2016 Edition. Retreived from http://www.phac-aspc.gc.ca/publicat/hpcdp-pspmc/36-8/assets/pdf/ar-04-eng.pdf
- BackgroundSaher, MN (2014). Report of the Auditor General of Alberta: Health- Chronic Disease Management. Edmonton, AB: Office of the Auditor General of Alberta.
- Background: PubMed 15928225Fortin M, Bravo G, Hudon C, Vanasse A, Lapointe L. Prevalence of multimorbidity among adults seen in family practice. Ann Fam Med. 2005 May-Jun;3(3):223-8. doi: 10.1370/afm.272.
- Background: PubMed 15353000Bayliss EA, Bayliss MS, Ware JE Jr, Steiner JF. Predicting declines in physical function in persons with multiple chronic medical conditions: what we can learn from the medical problem list. Health Qual Life Outcomes. 2004 Sep 7;2:47. doi: 10.1186/1477-7525-2-47.
- Background: PubMed 17403548Condelius A, Edberg AK, Jakobsson U, Hallberg IR. Hospital admissions among people 65+ related to multimorbidity, municipal and outpatient care. Arch Gerontol Geriatr. 2008 Jan-Feb;46(1):41-55. doi: 10.1016/j.archger.2007.02.005. Epub 2007 Apr 2.
- Background: PubMed 15380021Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51.
- Background: PubMed 22143232Manns BJ, Tonelli M, Zhang J, Campbell DJ, Sargious P, Ayyalasomayajula B, Clement F, Johnson JA, Laupacis A, Lewanczuk R, McBrien K, Hemmelgarn BR. Enrolment in primary care networks: impact on outcomes and processes of care for patients with diabetes. CMAJ. 2012 Feb 7;184(2):E144-52. doi: 10.1503/cmaj.110755. Epub 2011 Dec 5.
- Background: PubMed 17301194McAlister FA, Majumdar SR, Eurich DT, Johnson JA. The effect of specialist care within the first year on subsequent outcomes in 24,232 adults with new-onset diabetes mellitus: population-based cohort study. Qual Saf Health Care. 2007 Feb;16(1):6-11. doi: 10.1136/qshc.2006.018648.
- Background: PubMed 17259516Shah BR, Hux JE, Austin PC. Diabetes is not treated as a coronary artery disease risk equivalent. Diabetes Care. 2007 Feb;30(2):381-3. doi: 10.2337/dc06-1654. No abstract available.
- Background: PubMed 17384345Sirois C, Moisan J, Poirier P, Gregoire JP. Suboptimal use of cardioprotective drugs in newly treated elderly individuals with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1880-2. doi: 10.2337/dc06-2257. Epub 2007 Mar 23. No abstract available.
- Background: PubMed 15189757Supina AL, Guirguis LM, Majumdar SR, Lewanczuk RZ, Lee TK, Toth EL, Johnson JA. Treatment gaps for hypertension management in rural Canadian patients with type 2 diabetes mellitus. Clin Ther. 2004 Apr;26(4):598-606. doi: 10.1016/s0149-2918(04)90062-8.
- Background: PubMed 11228171Tonelli M, Bohm C, Pandeya S, Gill J, Levin A, Kiberd BA. Cardiac risk factors and the use of cardioprotective medications in patients with chronic renal insufficiency. Am J Kidney Dis. 2001 Mar;37(3):484-9.
- Individual participant dataSharing planned: No
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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 ENCOMPASS Intervention 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 7 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 utilization (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 NCT03077386, 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 23 May 2024.