Heart Failure
Conditions
Keywords
Diet, low-sodium, caregivers
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.
Interventions
BEHAVIORALFamily 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.
BEHAVIORALusual 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.
Sponsors
National Institute of Nursing Research (NINR)
Misook L. Chung
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
a randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | Up to 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| All Cause Hospitalization/Mortality | 12 months | Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up. |
Countries
United States
Participant flow
Recruitment details
We recruited a total of 316 individuals consisting of 158 patients with heart failure and 158 primary caregivers at outpatient cardiology clinics in one academic medical center and one community medical center.
Pre-assignment details
As a result of the screening of 5,365 patients, a total of 819 dyads who met the inclusion criteria and 214 dyads verbally agreed to participate (26.1% recruitment rate). Of these, 199 dyads provided written consent,but 41 dyads withdrew before the home visit for baseline data collection. Thus, only158 dyads (316 individuals: 158 patients and 158 caregivers) completed the baseline assessment. Thus, we reported the final sample of 158 patients with heart failure in this report.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Family SWaP intervention with mini iPad: 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. | 158 |
| 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.
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. | 158 |
| Total | 316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Busy schedule | 14 | 2 |
| Overall Study | caregivers' health condition and not becoming non-caregiver | 5 | 0 |
| Overall Study | Lost to Follow-up | 19 | 11 |
| Overall Study | patients' new health condition such as cancer | 10 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Family SWaP Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 58 Participants | 60 Participants | 118 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 98 Participants | 198 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants | 156 Participants | 312 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 23 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 125 Participants | 132 Participants | 257 Participants |
| Region of Enrollment United States | 158 participants | 158 participants | 316 participants |
| Sex: Female, Male Female | 88 Participants | 86 Participants | 174 Participants |
| Sex: Female, Male Male | 70 Participants | 72 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 158 | 2 / 158 |
| other Total, other adverse events | 0 / 158 | 0 / 158 |
| serious Total, serious adverse events | 23 / 158 | 28 / 158 |
Outcome results
Primary
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.
Time frame: Up to 1 year
Population: Of the 158 patient-caregiver dyads (158 patients with heart failure and 158 primary caregivers), we report the primary outcome of patient adherence to the sodium-restricted diet. Of the 158 patients with heart failure, 79 patients were randomly assigned to the Family Sodium Watchers intervention group and another 79 patients were assigned to the usual care group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family SWaP Intervention | Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | Baseline | 4390.2 mg/day | Standard Deviation 2286.1 |
| Family SWaP Intervention | Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | 4-month | 3338.1 mg/day | Standard Deviation 1580.1 |
| Family SWaP Intervention | Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | 12-month | 3523.1 mg/day | Standard Deviation 2173.3 |
| Usual Care | Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | Baseline | 4048.9 mg/day | Standard Deviation 1969.6 |
| Usual Care | Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | 4-month | 4402.9 mg/day | Standard Deviation 2214.6 |
| Usual Care | Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels | 12-month | 3855.3 mg/day | Standard Deviation 1446.6 |
Secondary
All Cause Hospitalization/Mortality
Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.
Time frame: 12 months
Population: Events included death and hospitalization events for participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Family SWaP Intervention | All Cause Hospitalization/Mortality | 23 first event during follow up |
| Usual Care | All Cause Hospitalization/Mortality | 28 first event during follow up |