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Completed

NCT Number: NCT03560206

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

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky HealthCare

Lexington, Kentucky, 40536, United States

About this study

Heart failure (HF) emerged as a significant public health threat in the 1990s and has now reached epidemic proportions. Despite advances in the medical treatment of HF, patients with HF face frequent hospitalizations for acute exacerbations. Inadequate self-care strategies, in particular non-adherence to a sodium restricted diet (SRD), is a main cause of these rehospitalizations. Prior interventions to increase adherence have focused on increasing knowledge about restricting sodium in the diet have met with limited success. Unaddressed by these interventions are the major barriers of measuring and tracking daily sodium intake, family members who continue to eat high sodium diets, and a preference for salty foods-particularly in the elderly who have a decreased sense of taste. It is possible to retrain the taste buds to enjoy low salt foods by gradually reducing the amount of sodium in foods over the course of 16 weeks. This retraining works best with direct involvement and support from family members. 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 SRD by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Eligible patients will:

  • have diagnosis of chronic HF with either preserved or reduced ejection fraction
  • have a dedicated primary family caregiver
  • be able to speak and write English

Eligible caregivers will:

  • be a primary caregiver identified by the patient
  • the spouse, committed partner, or family member living with the HF patient
  • be able to speak and understand English
  • have no obvious major clinical cognitive impairment that would impair ability to give informed consent
  • have no major co-morbidities (i.e. HF, cancer, renal/liver failure, or uncontrolled diabetes as determined by self-report).

Exclusion criteria

Patients will be excluded if they have:

  • major clinical cognitive impairment (i.e., dementia, Alzheimer disease, and severe stroke)
  • a co-existing terminal illness (e.g., cancer)
  • a referral for heart transplantation
  • a dietary prescription that prevents following a 2-3 gram sodium diet (e.g., clinician does not support use of a SRD).
  • no dedicated caregivers

Treatment and study plan

Family SWaP intervention

Behavioral

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.

Other names: Family SWaP

Usual Care

Behavioral

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.

Primary outcomes

  1. Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels

    Time frame: Up to 1 year

    Baseline: Patient adherence to a sodium-restricted diet was assessed using 24-hour urinary sodium excretion at 3-time points at baseline, 4-months, and 12 months.

Secondary outcomes

  1. All Cause Hospitalization/Mortality

    Time frame: 12 months

    Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.

Sponsors and collaborators

Lead sponsor

Misook L. Chung

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: FAMSWAP

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2018
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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