Video Home Visits for Dietary Counselling
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual home visits
BehavioralThese 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Urinary sodium
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)
Time frame
baseline, 12 weeks, 24 weeksSecondary outcomes
1
Food Frequency Questionnaire (FFQ)
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)
Time frame
baseline, 12 weeks, 24 weeks2
Short Sodium Knowledge Survey (SKSS)
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)
Time frame
baseline, 12 weeks, 24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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