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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR012967 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family SWaP intervention | Experimental | 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. |
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| Usual Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family SWaP intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Hospitalization/Mortality | Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up. | 12 months |
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Inclusion Criteria:
Eligible patients will:
Eligible caregivers will:
Exclusion Criteria:
Patients will be excluded if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Misook L Chung, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky HealthCare | Lexington | Kentucky | 40536 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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158 patients and 158 caregivers participated in this dyadic research. We report age, gender, and ethnicity for total individuals by combining patients and caregivers.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/day | Up to 1 year |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Hospitalization | Cardiac disorders | Serious | Systematic Assessment | Inpatient hospitalization related to cardiovascular health conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Misook Chung, PhD | University of Kentucky | (859) 323-8024 | misook.chung@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2020 | Oct 15, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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a randomized controlled trial
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|
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| usual care | 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. |
|
| caregivers' health condition and not becoming non-caregiver |
|
| Busy schedule |
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| patients' new health condition such as cancer |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | All Cause Hospitalization/Mortality | Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up. | Events included death and hospitalization events for participants. | Posted | Number | first event during follow up | 12 months |
|
|
|
| 4 |
| 158 |
| 23 |
| 158 |
| 0 |
| 158 |
| EG001 | 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. | 2 | 158 | 28 | 158 | 0 | 158 |
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| Non-cardiac Hospitalization | Respiratory, thoracic and mediastinal disorders | Serious | Systematic Assessment | Inpatient hospitalization related to non-cardiac reasons. We did not collect specific causes of non-cardiac hospitalization. |
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| Cardiac death | Cardiac disorders | Serious | Systematic Assessment | Death related to the cardiovascular health condition |
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| Non-cardiac Death | Investigations | Serious | Systematic Assessment | Death related to non-cardiac death. We did not collect specific causes of non-cardiac death. |
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