ClinicalTrials.Veeva

Menu

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

M

Misook L. Chung

Status

Completed

Conditions

Heart Failure

Treatments

Behavioral: usual care
Behavioral: Family SWaP intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03560206
46045
R01NR012967

Details and patient eligibility

About

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.

Full 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.

Enrollment

316 patients

Sex

All

Ages

21 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

316 participants in 2 patient groups

Family SWaP intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Family SWaP intervention
Usual Care
Active Comparator group
Description:
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.
Treatment:
Behavioral: usual care

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems