CLINICAL TRIAL

Community Health Navigator Program for Chronic Kidney Diseases

Stage III
Recruiting · 18+ · All Sexes · Edmonton, Canada

This study is evaluating whether a patient navigation program can improve care for patients with multiple long-term health conditions.

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About the trial for Chronic Kidney Diseases

Eligible Conditions
Coronary Artery Disease · Congestive Heart Failure (CHF) · Lung Diseases, Obstructive · Ischemic Heart Disease · Diabetes Mellitus, Type 2 · Renal Insufficiency, Chronic · Heart Failure · Asthma · Pulmonary Disease, Chronic Obstructive · Chronic Kidney Disease (CKD) · Kidney Diseases · Hypertension · Heart Diseases · Myocardial Ischemia · Chronic Obstructive Pulmonary Disease (COPD)

Treatment Groups

This trial involves 2 different treatments. Community Health Navigator Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Community Health Navigator Program
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
or Stage 4 chronic kidney disease (estimated glomerular filtration rate ≤ 15 mL/min/1.73m2), or end-stage renal disease (estimated glomerular filtration rate < 15 mL/min/1.73m2, or on dialysis, or with a kidney transplant) Chronic kidney disease is classified into five stages, with stage 3b or greater being the most severe show original
The patient has asthma and has visited their doctor twice in the past year. show original
poorly controlled diabetes with a hemoglobin A1C of ≥ 9% on at least one occasion within the past year or a glycated protein level of ≥ 6. show original
The patient has congestive heart failure, which is a condition where the heart can't pump enough blood to the rest of the body. show original
uncontrolled diabetes mellitus; current smoker People who have poorly controlled hypertension, uncontrolled diabetes mellitus, or are current smokers are at a higher risk for a stroke. show original
Individuals with ischemic heart disease who receive care in the Veterans Health Administration (VHA) are at risk for hospitalization and death show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 36 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 36 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 36 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Community Health Navigator Program will improve 1 primary outcome and 33 secondary outcomes in patients with Chronic Kidney Diseases. Measurement will happen over the course of Up to 12 months.

Self-reported Smoking status
UP TO 12 MONTHS
Self-reported current smoking status, smoking cessation behaviours, and smoking frequency.
UP TO 12 MONTHS
Health-related quality of life
UP TO 12 MONTHS
EuroQol EQ-5D-5L
UP TO 12 MONTHS
Smoking status
UP TO 12 MONTHS
Self-reported smoking status.
UP TO 12 MONTHS
Perceived social support
UP TO 12 MONTHS
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
UP TO 12 MONTHS
Depressive symptoms
UP TO 12 MONTHS
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)
UP TO 12 MONTHS
Health-related quality of life as assessed by EuroQol EQ-5D-5L
UP TO 12 MONTHS
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
UP TO 12 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of chronic kidney diseases?

The prevalence of CKDs among a cohort of CKD-prone African Canadians was greater than anticipated in that age group. CKD was more prevalent in women than in men, and older age was a negative predictor of CKD.

Anonymous Patient Answer

What causes chronic kidney diseases?

The cause(s) of CKDs seem to be multifactorial, involving different pathways which may be related and interacting with the genetic factor. The environmental factors such as diabetes, hypertension, hypertension-kidney diseases, and other factors also appear to be involved.

Anonymous Patient Answer

How many people get chronic kidney diseases a year in the United States?

A significant proportion of patients with CKD die of unknown etiology. The data collected here are applicable to the whole United States population, therefore they can be used to estimate the burden of disease related to CKD in the US.

Anonymous Patient Answer

What is chronic kidney diseases?

CKD is a frequent and disabling kidney disease. A high proportion of patients has chronic kidney disease when they are diagnosed with CKD, and CKD is a major cause of advanced end stage kidney disease.

Anonymous Patient Answer

Can chronic kidney diseases be cured?

Although it often seems as if the medical profession has come close to achieving the 'cure' of advanced chronic kidney diseases, its effectiveness is currently limited to the initial alleviation of their clinical manifestations.

Anonymous Patient Answer

What are common treatments for chronic kidney diseases?

The majority of treatments for CKD have high efficacy, mostly due to effective and tolerable dosing regimens, but the most prescribed medications may cause severe adverse events or lead to a less effective dosing regimen.

Anonymous Patient Answer

What is the primary cause of chronic kidney diseases?

Results from a recent paper suggest that the main causative factor for prevalent CKD, regardless of the underlying causes of CKD, is long-term exposure to environmental toxins. For the primary prevention of CKD we suggest the substitution of traditional tobacco smoking with the use of herbal products or herbal cigarette.

Anonymous Patient Answer

How serious can chronic kidney diseases be?

The CKD-EPI equation overestimates eGFR for patients with severe chronic kidney diseases. However, the CKD-EPI equation has good clinical applicability and is probably not applicable for all patient groups. We conclude that it can be used to define stages of CKD and may be used for the clinical risk prediction in patients with CKD and also as a reference in clinical practice.

Anonymous Patient Answer

Is community health navigator program safe for people?

Community health navigation is as safe as usual care in selected patient populations, especially for low-risk patients with chronic kidney disease. Although no adverse events were noted, it appeared that navigation increased communication between primary care providers and patients.

Anonymous Patient Answer

Have there been other clinical trials involving community health navigator program?

The CHNP model effectively reduces disparities in diabetes care and reduces patient-centered diabetes care. The study did not support the CHNP model as a stand-alone intervention that increases participation in diabetes care and outcomes in the home setting.

Anonymous Patient Answer

Is community health navigator program typically used in combination with any other treatments?

Although navigation and CPN programs are widely used in many countries, they were used in combination with any other treatment in only 10% of studies. This raises the possibility that they may work synergistically. There has been speculation that CPN may have the potential to improve the quality of care by increasing awareness of patients' social and environmental needs that are otherwise missed by health professionals. To evaluate the effectiveness of CPN, well-designed randomized controlled trials are needed to determine whether such programs have any clinical effect on patient outcome (e.g., prolonging survival or improving patient-reported HRQOL).

Anonymous Patient Answer

What are the common side effects of community health navigator program?

The PHNN program in this study was proven successful in facilitating communication between the PHNN program and its participants regarding the course of the program and their treatment. Participants reported a high satisfaction rate with PHNN. With improvements in technology, patient-health navigator communication is easier than before.

Anonymous Patient Answer
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