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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family SWaP intervention
usual care
Sponsored by
Misook L. Chung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Diet, low-sodium, caregivers

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Kentucky HealthCare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family SWaP intervention

Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All Cause Hospitalization/Mortality
Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.

Full Information

First Posted
January 6, 2015
Last Updated
February 2, 2022
Sponsor
Misook L. Chung
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03560206
Brief Title
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Acronym
FAMSWAP
Official Title
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Misook L. Chung
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Diet, low-sodium, caregivers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family SWaP intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Family SWaP intervention
Other Intervention Name(s)
Family SWaP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention 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.
Primary Outcome Measure Information:
Title
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
All Cause Hospitalization/Mortality
Description
Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misook L Chung, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky HealthCare
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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