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Video Home Visits for Dietary Counselling

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ClinicalTrials.gov Identifier: NCT04634851
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This pilot study aims to develop a protocol for home video informed dietary counseling with the goal of reducing overall sodium consumption among kidney stone formers. To accomplish this the investigators will: 1)Assess which data available on video visits are most informative to convey patient sodium consumption, and 2) Administer virtual home visits with informed dietary counseling in our intervention arm and compare this to standard dietary counseling looking specifically at the outcome of 24-hour urine sodium excretion results over time. This study will benefit dramatically from the rapid growth of telehealth medical visits as a consequence of the SARS-CoV-2 pandemic, with the ultimate goal to improve and adapt patient dietary counseling for the prevention of kidney stone disease in the new and evolving era of telehealth.

Condition or disease Intervention/treatment Phase
Technology Diet Habit Behavioral: Virtual home visits Not Applicable

Detailed Description:

Urolithiasis affects 1 in 11 Americans and is associated with annual health care expenditures of up to $4.5 billion. Fifty percent of stone risk can be attributed to diet and fluid intake. Modifications in sodium intake can dramatically reduce risk of kidney stone disease as determined by 24-hour urine results. Despite this understanding, dietary counseling is largely ineffective as kidney stone formers have difficulty adhering to low sodium diets. The precise reasons behind this are unknown, but it is hypothesized that socioeconomic factors such as low income and low education contribute to a lack of knowledge of, and access to, healthy alternatives to salty foods. The relationship between lithogenic diet consumption and stone disease requires a more in depth understanding of patients' home food environments, dietary habits, and perceived barriers to following a low-sodium diet. This understanding will help direct appropriate interventions to prevent recurrent stones.

Routine historic face-to-face clinic visits rapidly have been replaced with telehealth encounters with the SARS-CoV-2 pandemic. Such changes will likely remain the standard of care and will define the new "normal" for some time. This presents an opportunity to integrate robust information now available through the exponential growth of video visits with directed dietary counseling. Through video exchange with patients in their homes an abundance of previously untapped information is immediately available to healthcare providers. Smartphone video capabilities are available to most stone patients irrespective of their financial status. Images from telehealth video visits, including patient lifestyle, behaviors, resources, and home environment will give objective data as to types of food consumed regularly by patients and their capacity to prepare healthy foods at home.

The following specific aims are proposed: 1) Assess which data from video visits are most informative for identifying how to counsel patients to reduce patient sodium intake, and 2) Administer virtual home visit-informed individualized dietary counseling to stone formers and compare this to survey-informed dietary counseling. 24-hour urinary sodium results and patient dietary sodium knowledge and perceptions will be monitored over 6 months. This study will leverage the rapid growth of telehealth medical visits as a consequence of the SARS-CoV-2 pandemic to better understand and improve food consumption behavior of recurrent stone formers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot study comparing intervention (virtual dietary counselling) versus standard of care
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Dietary Habits for Kidney Stone Formers Using Telehealth Directed Individualized Nutritional Counseling
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
These participants will get virtual home visits with the urologist and dietitian
Behavioral: Virtual home visits
These participants will have a tailored evaluation of dietary choices based on their home dietary environment (refrigerator, pantry, etc). This will be conducted over video exchange.

No Intervention: Control
These participants will get standard urologist and dietitian counseling



Primary Outcome Measures :
  1. Urinary sodium [ Time Frame: baseline, 12 weeks, 24 weeks ]
    24hr urinary sodium, mean change in mmol/24hrs of excreted urinary sodium from baseline over 24 weeks (Three time points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be mean change from baseline. We will take the average of change from baseline at 12 weeks and change from baseline at 24 weeks)


Secondary Outcome Measures :
  1. Food Frequency Questionnaire (FFQ) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    Change in response to NutritionQuest® block sodium screener Food Frequency Questionnaire (FFQ), (Three points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be change from baseline over time. We will look specifically for a reduction in self reported weekly consumption of high sodium foods including soups, pizza, hot dogs, lunch meets, table salt, cooking salt, etc. Results will be noted for change from baseline at 12 weeks and at 24 weeks)

  2. Short Sodium Knowledge Survey (SKSS) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    Change in response to Short Sodium Knowledge Survey (SKSS), (Three points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be change from baseline over time. We will look specifically for a an increased frequency in accurate identification of high sodium foods and accurate identification of dietary sodium intake recommendations. Results will be noted for change from baseline at 12 weeks and at 24 weeks)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients known to have a history of calcium-based kidney stone disease verified by stone analysis (stones containing calcium oxalate(CaOx) or calcium phosphate(CaP) on stone analysis), or patients with a diagnosis of kidney stone disease verified by imaging (computerized tomography, ultrasound, or plain film/x-ray) and a prior 24-hour urine results with elevated SS CaOx>8 or SS CaP>1.25.
  • Patients 18 years or older.
  • Patients with a smartphone, internet capable tablet, or video capable laptop.
  • Patients with a household member with a smartphone, internet capable tablet, or video capable laptop.

Exclusion Criteria:

  • Pregnant patients.
  • Patients unable to produce a urine sample.
  • Patients who have previous surgical reconstruction involving incorporation of bowel in the urinary tract.
  • Patients with known sodium regulation abnormalities (adrenal tumors, pituitary tumors, glucocorticoid deficiency, hypothyroidism, syndrome of inappropriate antidiuretic hormone secretion, nephrotic syndrome, severe congestive heart failure, severe hepatic impairment, etc.).
  • Patients on medications significantly affecting urinary sodium levels (lithium, amphotericin, vasopressin V2-receptor antagonists, lactulose, for example).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634851


Contacts
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Contact: David Bayne, MD, MPH 4153532200 david.bayne@ucsf.edu
Contact: Marshall Stoller, MD 4153532200 marshall.stoller@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: David Bayne, MD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04634851    
Other Study ID Numbers: UCSFUroVV
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will not share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No