CLINICAL TRIAL

STEPS Health System Outreach intervention for Chronic Kidney Disease (CKD)

Recruiting · 18+ · All Sexes · Durham, NC

System Interventions to Achieve Early and Equitable Transplants (STEPS) Study

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About the trial for Chronic Kidney Disease (CKD)

Eligible Conditions
Chronic Kidney Disease (CKD) · Kidney Diseases · Renal Insufficiency, Chronic

Treatment Groups

This trial involves 2 different treatments. STEPS Health System Outreach Intervention 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.
STEPS Health System Outreach intervention
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 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
is a legal requirement in many states In order to provide oral informed consent, you must be able to understand the information provided to you show original
People aged 18 to 75 years old can be either male or female. show original
and most recent hospitalization for AKI, proteinuria, congestive heart failure, or sepsis The presence of CKD (2 eGFRs less than 60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10% and most recent hospitalization for AKI, proteinuria, congestive heart failure, or sepsis indicates a high risk for mortality. show original
To be able to communicate effectively over the phone, you need to have strong English skills and be able to hear and understand what the other person is saying. show original
Willing to comply with all study procedures and be available for the duration of the study
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: baseline, 6 months, 12 months, 18 months
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months, 12 months, 18 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: baseline, 6 months, 12 months, 18 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 STEPS Health System Outreach intervention will improve 1 primary outcome and 12 secondary outcomes in patients with Chronic Kidney Disease (CKD). Measurement will happen over the course of 18 months.

Patient reported identification of a living donor
18 MONTHS
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
18 MONTHS
Patient reported family discussions
18 MONTHS
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
18 MONTHS
Placement on deceased kidney donor waitlist
18 MONTHS
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS
18 MONTHS
Patient reported physician discussions
18 MONTHS
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
18 MONTHS
Health system reported completion of transplant evaluation
18 MONTHS
Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports
18 MONTHS
Health system reported initiation of transplant evaluation
18 MONTHS
Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports
18 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 causes chronic kidney disease (ckd)?

The overall incidence and prevalence of CKD are increasing. Diabetes has become one of the most important risk factors for CKD. As diabetes persists in epidemic proportions, an urgent need exists to detect and treat CKD as soon as possible.

Anonymous Patient Answer

What is chronic kidney disease (ckd)?

Chronic kidney disease defines a substantial proportion of renal care expenditure in high-income countries, particularly in Canada, which is one of the largest medical systems in the world. Clinical and economic data from this study reveal considerable economic costs associated with chronic kidney disease, including higher hospital admission rates and higher costs of treatment.

Anonymous Patient Answer

What are the signs of chronic kidney disease (ckd)?

Symptoms of chronic kidney disease can include fatigue, feeling tired often, and feeling unwell on a daily basis. Many patients with chronic kidney disease also experience symptoms of headaches, shortness of breath, swelling in their back or leg muscles or pain during movement like walking or exercising. Kidney disease can also result in difficulty removing extra water and minerals such as sodium and phosphate during kidney dialysis treatment. Changes in the concentration of proteins like albumin and creatinine in the blood may also be a sign of chronic kidney disease. There are many ways to test for chronic kidney disease including blood tests, urine test and kidney ultrasounds.

Anonymous Patient Answer

Can chronic kidney disease (ckd) be cured?

The progression of CKD can be delayed to a certain extent by modifying certain risk factors, including proper weight management and the control of blood pressure. We should encourage our patients with CKD to keep up this routine to maintain good health and optimize their quality of life.

Anonymous Patient Answer

How many people get chronic kidney disease (ckd) a year in the United States?

3.6 million people have echolucent CKD in the United States. 7.1 percent of U.S. adults, and 5.2 percent of U.S. adults under the age of 18. 4.5 percent of men and 3.7 percent of women have echoluent or mildly elevated CKD or CKD. In the pediatric population, 1 percent of boys and 1.4 percent of girls have echoluent or mildly elevated CKD or CKD. 2.4 percent of these children have a history of CKD and 0.2 percent are diagnosed with CKD.

Anonymous Patient Answer

What are common treatments for chronic kidney disease (ckd)?

Patients with CKD receive therapies including: nutrition counseling to manage dietary protein imbalance; renal replacement therapy, including dialysis, peritoneal dialysis or renal transplantation; and medications to control blood pressure, hypertension, hypercholesterolemia, and osteoporosis.

Anonymous Patient Answer

Have there been other clinical trials involving steps health system outreach intervention?

A community organization (CA) can conduct clinical trials. The CA can engage key professionals working in a community with a population of end users who may not have access to clinical trials for a given medical condition.

Anonymous Patient Answer

How does steps health system outreach intervention work?

Stepwise system redesign has shown significant improvement in people's self-management and self-reported outcomes and an enhanced use of services resulting in reduced health care expenditure. A further evaluation is required to confirm any sustained effects.

Anonymous Patient Answer

Who should consider clinical trials for chronic kidney disease (ckd)?

Many CKD patients are reluctant to join clinical trials because of the unpleasant side effects of trial drugs. A review of the available literature and clinical experience indicated that the most important factors to consider are baseline risk and overall benefit at trial initiation, and not trial duration or type of drug.

Anonymous Patient Answer

Is steps health system outreach intervention typically used in combination with any other treatments?

Results from a recent clinical trial of this study show evidence that the combination of intensive case management with a usual care follow-up system resulted in a lower incidence of progression to ESRD and greater survival.

Anonymous Patient Answer

What is the primary cause of chronic kidney disease (ckd)?

Many factors can contribute to CKD progression including aging, gender, lifestyle and kidney diseases. In some cases, CKD may not be related to the causes of CKD like diabetes, chronic high blood pressure or a urinary tract infection.

Anonymous Patient Answer

What are the latest developments in steps health system outreach intervention for therapeutic use?

While there remains plenty of work to be done for the ultimate development of health technology, the evidence-based and cost-effective interventions for therapeutic use have increased dramatically, especially in the last 5 years.

Anonymous Patient Answer
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