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

NCT03560206 | Completed Results DMC

• 2 other identifiers: 46045R01NR012967
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Diet, low-sodium; caregivers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• All Cause Hospitalization/Mortality

  12 months

Study Arms (2)

Family SWaP intervention

EXPERIMENTAL

an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.

Behavioral: Family SWaP intervention

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: usual care

Interventions

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.

Also known as: Family SWaP

Family SWaP intervention

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.

Usual Care

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Misook L. Chung: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Kentucky HealthCare

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Misook Chung, PhD
• Organization: University of Kentucky

misook.chung@uky.edu

(859) 323-8024

Study Officials

• Misook L Chung, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a randomized controlled trial

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: June 18, 2018
• Study Start: March 1, 2015
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 25, 2022
• Results First Posted: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)