Sodium Watchers Program - Hypertension (SWAPHTN)
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|ClinicalTrials.gov Identifier: NCT04076280|
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Sodium Watcher Program-Hypertension Behavioral: Usual Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sodium Watchers Program - Hypertension|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: SWAP Intervention
The participants are randomized using a table of random numbers pre-generated by a computer assigning them to the Sodium Watcher Program.
Behavioral: Sodium Watcher Program-Hypertension
The Sodium Watcher Program -Hypertension intervention consists of 14 weeks of education [4 weekly education sessions (45 minutes)followed by 5 bi-weekly sessions 5-20 minutes] that will be held at the dyads' preferred time delivered to their homes using a video conferencing program through an iPad.
Active Comparator: Usual Care
The participants are randomized using a table of random numbers pre-generated by a computer assigning them to the usual care group.
Behavioral: Usual Care
Participants in the usual care group receive their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium restricted diet and take medications as ordered. Usual care consists of recommendations to follow a sodium restricted diet, but without explicit skills training including instructions on gradual adaptation to sodium restricted diet, follow-up of progress or provision of monitoring.
- Change in oral salt taste sensitivity [ Time Frame: up to 36 weeks ]Salt taste acuity will be tested by using the "updown" procedure. In the up trial, samples are given from lowest to highest salt concentration. Patients swish samples in the mouth for 2-3 seconds, expectorate, and then judge the saltiness of solution. The mouth is rinsed with 10 mL of distilled water between samples. When patients detect salt taste in two consecutive samples, the lower concentration of the two samples is recorded as the level of salt taste sensitivity. In the down trial, patients are given samples in reverse order from highest to lowest concentration and when no salt taste is detected in two consecutive samples, the level of salt taste sensitivity is then recorded as the concentration of the immediately preceding sample. Participants will perform this task at baseline and approximately at 20 weeks at the end of the intervention (up to 36 weeks). Data will be presented as the average as their high and low sodium sensitivity over time compared between groups.
- Change in blood pressure over time [ Time Frame: up to 36 weeks ]Systolic and diastolic blood pressures are preferred for use in hypertension classification. Mercury sphygmomanometers still are the preferred device .The position of the patient can have a sizable impact on blood pressure measurements. For the most accurate measurement, the AHA recommends that the patient be relaxed and seated with legs uncrossed and back and arm supported. For correct cuff placement, the midline of the cuff bladder should be positioned over the arterial pulsation in the patient's upper arm following palpation of the brachial artery in the antecubital fossa.The cuff should be inflated to at least 30 mm Hg above the point at which the radial pulse disappears. The cuff should then be deflated at a rate of 2 to 3 mm Hg per second. At least two readings should be taken, with a one-minute interval between them, and the average of the measurements recorded. Data will be presented as an average of the two measurements taken.
- Change in adherence to sodium restricted diet over time [ Time Frame: up to 36 weeks ]Participants will complete a 24-hour urinary sodium excretion test at baseline and at 20 weeks after the intervention is complete (up to 36 weeks). 24 hour urinary sodium excretion is tested by collecting all urine excreted over the course of 24 hours. Participants are asked to note the time when they start in a written log, then discard the first urine after that time. They will then collect all urine excreted over the course of the next 24 hours, noting down the time and amount excreted each time in the written log. Urine is stored in a container and does not need refrigeration. 24 Hour Urine Sodium Samples will be analyzed by the University of Kentucky clinical laboratory.Data will be presented as the amount of miligrams excreted per day.
- Change in dietary quality over time [ Time Frame: up to 36 weeks ]Participants will complete the Vio-Food Frequency Questionnaire at baseline and 20 weeks after the intervention is complete (up to 36 weeks). This scale is a web-based food frequency questionnaire that was developed by Viocare Technologies, Inc (Princeton, NJ). It will be used to generate the Health Eating Index-20120 score which is comprised of 12 components including total fruit, whole fruit, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids, refined grains, empty calories and sodium. Each component score ranges from 0 to 100 and the high score indicates better quality of dietary component. Changes in total HEI score as well as changes in the score of each of the 12 components provide an easy, scientifically sound, quantitative way to track changes in eating patterns over time.Data will be presented as change in the Health Eating Index -2010 score over time presented as mean plus or minus standard error.
- Change in Depression over time [ Time Frame: up to 36 weeks ]Participants will complete the PHQ-9 depression scale at baseline and 20 weeks after the intervention is complete. (up to 36 weeks) This scale measures depression by answering nine questions, each question is scored on a scale of 0-3 where 0 is no depressive symptoms and 3 is considered severe depressive symptoms. A score of 1-4 is minimal depression, a score of 5-9 is mild depression, a score of 10-14 is moderate depression, a score of 15-19 is moderately severe depression, and a score of 20-27 is severe depression. Data will be presented as the change in depression over time presented as the mean plus or minus the standard error.
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): NCT04076280
|Contact: Jennifer L Smith, PhDfirstname.lastname@example.org|
|Contact: Theresa Back, MSN||859-323-6656|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40506|
|Contact: Jennifer L Smith, PhD 859-323-8907 email@example.com|
|Principal Investigator:||Misook L Chung, PhD||University of Kentucky|