Clinical trial NCT03560206: Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Official title: Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Diet, low-sodium
caregivers
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-06-18
Enrollment: 316
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels
timeFrame: Up to 1 year
Secondary outcomes:
measure: All Cause Hospitalization/Mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky HealthCare
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Misook L Chung, PhD
role: PRINCIPAL_INVESTIGATOR
References: