What side effects are associated with this type of intervention?

The most common treatments for Chronic Kidney Disease (CKD) include dialysis and conservative management. Dialysis can lead to side effects such as fatigue, low blood pressure, muscle cramps, and infections at the access site. Conservative management, which focuses on symptom control without dialysis, may involve medications that can cause gastrointestinal issues, electrolyte imbalances, and potential drug interactions. Both approaches aim to manage symptoms and improve quality of life but come with their own sets of challenges and side effects.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Kidney Disease (CKD) include various pharmacologic therapies aimed at managing symptoms and slowing disease progression. These treatments often involve antihypertensive agents like ACE inhibitors and ARBs, which help control blood pressure and reduce proteinuria. Additionally, sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin and empagliflozin, have shown benefits in CKD patients by reducing the risk of heart failure and slowing kidney function decline. While these treatments are crucial, the DIAL-SDM trial focuses on enhancing communication and decision-making skills between nephrologists and patients, highlighting the importance of shared decision-making in managing CKD.

What other types of research exist?

Promising novel alternatives to DIAL-SDM for CKD patients considering treatment in 2024 include: 1) EpxDialysis, a digital-messaging platform that improves patient-to-dialysis center communication via text messaging and telephone technology, shown to increase appointment adherence and reduce hospitalizations. 2) Telemedicine interventions, which have demonstrated benefits in chronic disease management, including remote-patient monitoring and teleconsultation, enhancing patient engagement and self-management. 3) Workshops like PERCS-dialysis, which focus on improving communication skills of nephrologists in discussing difficult topics with patients, thereby enhancing shared decision-making.

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Shared Decision Making for Chronic Kidney Disease (DIAL-SDM Trial)

N/A

Waitlist Available

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

For Patients: Patient has already been seen by a palliative care clinician or is enrolled in hospice, Is already on dialysis, Hospitalized at the time of recruitment, Cognitive impairment, Does not speak English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve decision-making about dialysis for older patients with severe chronic kidney disease. Doctors will be trained to communicate better, and patients will receive coaching to help them express their treatment preferences. The goal is to ensure that treatment decisions align with the patients' values and improve their quality of life.

Who is the study for?

This trial is for patients aged 65 or older with advanced chronic kidney disease (stages 4 or 5) who haven't yet decided on dialysis and speak English. Their nephrologist must be part of the study and working at Strong Memorial Hospital. Caregivers involved in patient care can also participate.

What is being tested?

The trial tests a shared decision-making program (DIAL-SDM) against usual care for kidney disease treatment choices. Nephrologists will get communication training, while patients receive coaching to help them discuss their treatment preferences effectively.

What are the potential side effects?

Since this intervention involves education and communication rather than medication, there are no direct medical side effects; however, participants may experience emotional or psychological impacts from discussing sensitive health decisions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have already met with a palliative care doctor or are in hospice care, are currently receiving dialysis, are in the hospital, have trouble thinking clearly, or do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

acceptability of DIAL-SDM intervention

feasibility of DIAL-SDM intervention

Interventional procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: interventionExperimental Treatment1 Intervention

Group II: controlExperimental Treatment1 Intervention

Usual care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DIAL-SDM

2022

N/A

~110

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Kidney Disease (CKD) include lifestyle modifications, pharmacologic interventions, and shared decision-making processes. Lifestyle modifications such as dietary changes and exercise help manage blood pressure and blood sugar levels, slowing disease progression. Pharmacologic treatments, including ACE inhibitors, ARBs, and diuretics, work by controlling hypertension and reducing proteinuria, which are critical in preserving kidney function. Shared decision-making, as emphasized in the DIAL-SDM trial, involves active patient engagement and communication with healthcare providers, ensuring that treatment plans align with patient preferences and improve adherence. These treatments are crucial for CKD patients as they help manage symptoms, slow disease progression, and enhance the quality of life.

Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.Discussing Sexual Dysfunction with Chronic Kidney Disease Patients: Practice Patterns in the Office of the Nephrologist.