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

NCT ID: NCT03560206

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2020-07-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Family SWaP intervention

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.

Group Type: EXPERIMENTAL

Family SWaP intervention

Intervention Type: BEHAVIORAL

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.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: BEHAVIORAL

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.

Interventions

Family SWaP intervention

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

usual care

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

Other Intervention Names

Family SWaP

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Misook L. Chung

OTHER

Sponsor Role: lead

Responsible Party

Misook L. Chung

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Misook L Chung, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky HealthCare

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01NR012967

Identifier Type: NIH

Identifier Source: secondary_id

View Link

46045

Identifier Type: -

Identifier Source: org_study_id