Trial Outcomes & Findings for Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads (NCT NCT03560206)
NCT ID: NCT03560206
Last Updated: 2022-02-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
316 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2022-02-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
158
|
|
Overall Study
COMPLETED
|
108
|
140
|
|
Overall Study
NOT COMPLETED
|
50
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
caregivers' health condition and not becoming non-caregiver
|
5
|
0
|
|
Overall Study
Busy schedule
|
14
|
2
|
|
Overall Study
patients' new health condition such as cancer
|
10
|
1
|
Baseline Characteristics
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Baseline characteristics by cohort
| Measure |
Family SWaP Intervention
n=158 Participants
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.
|
Usual Care
n=158 Participants
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.
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
158 participants
n=5 Participants
|
158 participants
n=7 Participants
|
316 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Family SWaP Intervention
n=79 Participants
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.
|
Usual Care
n=79 Participants
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.
|
|---|---|---|
|
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels
Baseline
|
4390.2 mg/day
Standard Deviation 2286.1
|
4048.9 mg/day
Standard Deviation 1969.6
|
|
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels
4-month
|
3338.1 mg/day
Standard Deviation 1580.1
|
4402.9 mg/day
Standard Deviation 2214.6
|
|
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels
12-month
|
3523.1 mg/day
Standard Deviation 2173.3
|
3855.3 mg/day
Standard Deviation 1446.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Events included death and hospitalization events for participants.
Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.
Outcome measures
| Measure |
Family SWaP Intervention
n=79 Participants
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.
|
Usual Care
n=79 Participants
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.
|
|---|---|---|
|
All Cause Hospitalization/Mortality
|
23 first event during follow up
|
28 first event during follow up
|
Adverse Events
Family SWaP Intervention
Serious events: 23 serious events
Other events: 0 other events
Deaths: 4 deaths
Usual Care
Serious events: 28 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Family SWaP Intervention
n=158 participants at risk
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.
|
Usual Care
n=158 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Cardiac Hospitalization
|
9.5%
15/158 • Number of events 15 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
12.0%
19/158 • Number of events 19 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac Hospitalization
|
2.5%
4/158 • Number of events 4 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
4.4%
7/158 • Number of events 7 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
|
Cardiac disorders
Cardiac death
|
1.9%
3/158 • Number of events 3 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
0.63%
1/158 • Number of events 1 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
|
Investigations
Non-cardiac Death
|
0.63%
1/158 • Number of events 1 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
0.63%
1/158 • Number of events 1 • 1 year follow up from the baseline data collection
We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place