N/A
N=316
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03560206 ↗Enrolled (actual)
316
Serious AEs
16.1%
Results posted
Feb 2022
Primary outcome: Primary: Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels — 4390.2; 4048.9; 3338.1; 4402.9 mg/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family SWaP intervention (Behavioral); usual care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Misook L. Chung
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels |
4390.2; 4048.9; 3338.1; 4402.9; 3523.1; 3855.3 | — |
| SECONDARY All Cause Hospitalization/Mortality |
23; 28 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03560206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.