CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 316 enrolled
Drug / intervention
Family SWaP intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03560206
NCT03560206N/ACompleted

Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads

Misook L. Chung·interventional·Posted Jun 18, 2018·Updated Feb 25, 2022

In Brief

A clinical study evaluating Family SWaP intervention and usual care for Heart Failure. Completed, enrolled 316 participants across 1 site.

Detailed Summary

The Family Sodium Watcher program in this study is designed to improve adherence to a sodium restricted diet in patients with HF using strategies that educate both patients and family caregivers about sodium monitoring and that stress a gradual progressive adaptation to low sodium food for both patients and family caregivers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 18, 2018
Enrollment StartMar 1, 2015
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.0 years ago

Interventions

Family SWaP interventionbehavioral

The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet.

usual carebehavioral

The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.