Produce Prescription for Chronic Kidney Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Non-English speaker, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 months

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on providing produce prescriptions, so you may not need to change your medication routine.

Is the Produce Prescription treatment safe for humans?

The research articles do not provide specific safety data on the Produce Prescription treatment for chronic kidney disease or other conditions. ^{1 2 3 4 5}

How is the Produce Prescription treatment different from other treatments for chronic kidney disease?

The Produce Prescription treatment is unique because it involves providing fruits and vegetables to patients, which can help reduce kidney disease progression and cardiovascular risk factors. This approach contrasts with traditional dietary restrictions that limit high-potassium foods, offering a more balanced intake of nutrients while managing potassium levels. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this pilot clinical trial is to examine the feasibility, acceptability, and likely effect of a produce prescription intervention on patient-centered outcomes, health behaviors and health outcomes, among food insecure adults with chronic kidney disease stages 3 - 5. Participants will complete surveys at three timepoints, each three months apart, and complete health measurements at two timepoints 6 months apart. Half of the participants will be randomly assigned to the treatment where they will receive produce prescriptions with amount of the vouchers depending on their reported family size, every two weeks over six months. Researchers will compare the treatment group and the control group to see if there are any improvements in patient-centered outcomes (food and nutrition insecurity, health-related quality of life, depression and anxiety) and clinical outcomes (diet quality, metabolic acidosis, serum albumin, estimated GFR, blood pressure, and HbA1C).

Research Team

Nandta Mitra, PhD

Principal Investigator

University of Pennsylvania

Eliza Kinsey, PhD, MPH

Principal Investigator

University of Pennsylvania

Sarah Schrauben, MD, MSCE

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults with moderate to severe chronic kidney disease (stages 3-5) who don't have enough access to food. They should be willing to complete surveys and health measurements during the study. People with other significant health issues that could interfere with the study or those unable to follow its procedures may not qualify.

Inclusion Criteria

Positive screening of food insecurity in the electronic health record (EHR) within the prior 2 months

Lives within 5 miles of Philadelphia

At least one recent clinic visit at Penn Renal Care, or one clinic visit at Penn Primary Care (earliest six months before start of recruitment)

Exclusion Criteria

Does not meet all of the inclusion criteria

I am unable to give my consent.

Non-English speaker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive produce prescription vouchers every two weeks for six months

6 months

12 visits (virtual or in-person for voucher distribution)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person or virtual for surveys and health measurements)

Treatment Details

Interventions

• Produce Prescription

Trial Overview The trial is testing a 'produce prescription' where participants get vouchers for free produce based on family size, every two weeks for six months. The aim is to see if this improves their diet, quality of life, and specific health markers like blood pressure and kidney function compared to a control group not receiving these vouchers.

Participant Groups

Group I: Produce Prescription Experimental Treatment 1 Intervention

Participants will receive either $40 (families of 2 members or less) or $60 (families of more than 2 members) produce vouchers every 2 weeks for 6 months, for a total of $480 or $720. They will also receive compensation for completing different study related tasks and will receive their usual medical care.

Group II: Control Active Control 1 Intervention

Participants will not receive the produce prescription vouchers but will still receive compensation for completing different study related tasks and will receive their usual medical care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

In a 6-month study involving 67 chronic kidney disease (CKD) patients, a clinical pharmacist's evaluation identified 142 drug-related problems (DRPs) in 93% of participants, highlighting issues like untreated indications and incorrect dosages.

The intervention not only detected these problems but also facilitated immediate therapeutic adjustments and improved patient education, revealing that many patients were unaware of their treatment benefits and engaged in self-medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of drug-related problems in ambulatory chronic kidney disease patients: a 6-month prospective study. Belaiche, S., Romanet, T., Allenet, B., et al.[2019]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

In a 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.

The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Identification of drug-related problems in ambulatory chronic kidney disease patients: a 6-month prospective study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Kidney Function, Polypharmacy, and Potentially Inappropriate Medication Use in a Community-Based Cohort of Older Adults. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The Fruit and Veggies for Kidney Health Study: A Prospective Randomized Trial. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

Reduction of potassium content of green bean pods and chard by culinary processing. Tools for chronic kidney disease. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Microgreens Production with Low Potassium Content for Patients with Impaired Kidney Function. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Vegetable and Fruit Intake Frequency and Mortality in Patients With and Without Chronic Kidney Disease: A Hospital-Based Cohort Study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Reducing salt intake by urine chloride self-measurement in non-compliant patients with chronic kidney disease followed in nephrology clinics: a randomized trial. [2020]