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

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT03560206

46045

R01NR012967

Ages 21-90
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 giveinformed consent
have no major co-morbidities (i.e. HF, cancer, renal/liver failure, or uncontrolleddiabetes as determined by self-report).

Exclusion

Exclusion Criteria: Patients will be excluded if they have:

major clinical cognitive impairment (i.e., dementia, Alzheimer disease, and severestroke)
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., cliniciandoes not support use of a SRD).
no dedicated caregivers

Study Design

March 01, 2015

July 31, 2020

Study 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.

Connect with a study center

University of Kentucky HealthCare
Lexington, Kentucky 40536
United States
Site Not Available

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