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 long-term health conditions.

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About the trial for Chronic Kidney Diseases

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

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:
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);
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);
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).
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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 25 secondary outcomes in patients with Chronic Kidney Diseases. Measurement will happen over the course of Up to 12 months.

Provider satisfaction
UP TO 12 MONTHS
Based on semi-structured interviews.
UP TO 12 MONTHS
Household food security
UP TO 12 MONTHS
6-item Household Food Security Survey Module (HFSSM).
UP TO 12 MONTHS
General self-rated health
UP TO 12 MONTHS
1-item Self-Rated Health (SRH).
UP TO 12 MONTHS
Perceived social support
UP TO 12 MONTHS
8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS).
UP TO 12 MONTHS
Depressive symptoms
UP TO 12 MONTHS
9-item Patient Health Questionnaire (PHQ-9).
UP TO 12 MONTHS
Patient experience
UP TO 12 MONTHS
Based on semi-structured interviews.
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.

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

A total of 12.4 million Americans suffer from stage 3-5 chronic kidney diseases by 2030. This constitutes a huge health burden to the population in the United States.

Anonymous Patient Answer

What are the signs of chronic kidney diseases?

In children, the most common presenting symptom is non-specific abdominal pain. Other symptoms include weight loss, dehydration, fever, and anemia. An elevated serum creatinine level or a reduced glomerular filtration rate (GFR) are seen in the majority of children, but only a minority have blood work evidence for dehydration. An elevation in the triglyceride level is observed in a significant number of children. In adults, the most common presenting symptom is a swollen abdomen or ascites. Other symptoms include fever, cough, malaise, and unintentional weight loss. Blood tests are often normal in adults. In both children and adults, there is typically an increased rate of anemia and hypothyroidism.

Anonymous Patient Answer

What causes chronic kidney diseases?

This is an alarming cause of death worldwide, due not only to morbidity and mortality, but also to a loss of renal function. Chronic kidney disease is caused by multiple factors that interact with the kidney, its structure, and its functions.

Anonymous Patient Answer

What is chronic kidney diseases?

CKD is a global issue affecting people from all walks of life, which are undergoing continual progress in diagnosing and managing the diseases. This progress is being hampered by lack of knowledge. This review highlights the problems that are being faced by society, healthcare professionals and people with CKD to help them in managing the disease and keeping a normal quality of life. More efforts are needed to develop more advanced diagnostic and management tools for CKD in order to cope better and better with CKD.

Anonymous Patient Answer

What are common treatments for chronic kidney diseases?

Among the available prescription drugs, the most common are ACE inhibitor, antihypertensive, steroid, diuretic, and NSAIDs. These treatments are more effective than herbal medicine against proteinuria, edema, and lipemia.

Anonymous Patient Answer

Can chronic kidney diseases be cured?

CKD in itself is not a disease but rather a spectrum. A high degree of uncertainty exists in regard to the long-term prognosis if CKD is cured. Therefore, the objective of CKD treatment should not be to cure the CKD, and treatment for CKD should be individualized.

Anonymous Patient Answer

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

We found that there are common side effects of CPN intervention including mild to moderate fatigue and dizziness. We also found some evidences for moderate to severe gastrointestinal symptoms including nausea, vomiting, or discomfort.

Anonymous Patient Answer

Is community health navigator program safe for people?

CHN does not seem to be more risky (worse) than routine care for people with chronic kidney diseases. However, CHN may be more effective and may reduce the number of tests ordered for risk of complications and increase the number of patients able to undergo a renal transplant.

Anonymous Patient Answer

Have there been any new discoveries for treating chronic kidney diseases?

The first phase 3 trial of an injectable erythropoietin-related pharmaceutical, a novel erythropoietin/anti-angiogenic drug, demonstrated safety while also demonstrating efficacy. In addition, a non-peptide thrombopoietin, ixibrofen hydrochloride (HCl), has demonstrated superiority over nonpeptide thrombopoietin in the treatment of [anemia and osteoporosis in chronic kidney disease (CKD)](Hospitalizations for CKD and ESKD patients) in phase 3.

Anonymous Patient Answer

What are the latest developments in community health navigator program for therapeutic use?

The CHN programme is effective in enhancing the ability of patients to access specialist care and reduce hospitalizations, with some positive effects seen at 2 yr following commencement of the CHN program. However, its effectiveness is transient for one-year improvement in the quality of life.

Anonymous Patient Answer

Has community health navigator program proven to be more effective than a placebo?

CHNS intervention has had a role in providing information to patient and their family on dialysis and improving health care service. Although not significant, there was trend to improvement in self-care behavior and renal care. We are hopeful that the CHNS may be effective in improving the quality of renal care.

Anonymous Patient Answer

What is the latest research for chronic kidney diseases?

There is very little known and evidence to support the use of complementary therapies for chronic kidney disease. A large number of well-designed randomized controlled trials need to be performed to make up for the gap that exists in knowledge regarding chronic kidney disease to determine whether these therapies are effective or not. However, this research is ongoing and it is likely to shed more light on this very important issue.

Anonymous Patient Answer
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