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
|Condition or disease||Intervention/treatment||Phase|
|Technology Diet Habit||Behavioral: Virtual home visits||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pilot study comparing intervention (virtual dietary counselling) versus standard of care|
|Masking:||None (Open Label)|
|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|
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
- 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)
- 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)
- 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)
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
|Contact: David Bayne, MD, MPHemail@example.com|
|Contact: Marshall Stoller, MDfirstname.lastname@example.org|
|Principal Investigator:||David Bayne, MD, MPH||University of California, San Francisco|