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

Heart Failure Clinical Trial

— FAMSWAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560206
• Other study ID #: 46045
• Secondary ID: R01NR012967
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Family SWaP intervention
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 care
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.

Locations

Country	Name	City	State
United States	University of Kentucky HealthCare	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Misook L. Chung	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels	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.	Up to 1 year
Secondary	All Cause Hospitalization/Mortality	Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.	12 months