Heart FailureFAMSWAPNCT03560206
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
A study testing Family SWaP intervention in people with Heart Failure, run by Misook L. Chung at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Family SWaP intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky HealthCare
Lexington, Kentucky, 40536
About this study
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.
Read the 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
- Being tested
- Family SWaP intervention, usual care
- Keywords
- Diet, low-sodium, caregivers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family SWaP interventionBehavioural
Also called Family SWaP
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family SWaP intervention |
| 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. Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (1)
All Cause Hospitalization/Mortality
Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Mar 2015
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misook L. Chung
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Misook L. Chung, University of Kentucky
- Investigators
- Misook L Chung, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560206
- Sponsor's protocol ID
- 46045
- Other IDs
- R01NR012967
- Acronym
- FAMSWAP
- Status last verified
- Feb 2022
- First submitted
- 6 Jan 2015
- Last updated
- 25 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
- ClinicalTrials.gov ID
- NCT03560206
- Acronym / sponsor ID
- FAMSWAP / 46045
- Conditions
- Heart Failure
- Keywords
- Diet, low-sodium, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Misook L. ChungUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 25 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Family SWaP intervention | Experimental | Behavioral: Family SWaP interventionan 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. |
| Usual Care | Active comparator | Behavioral: usual careThe 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- be a primary caregiver identified by the patient
- the spouse, committed partner, or family member living with the HF patient
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family SWaP interventionAlso: Family SWaPThe 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. | Behavioural | Family SWaP intervention |
| usual careThe 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. | Behavioural | Usual Care |
Primary outcome
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels
Time frame: 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.
1 secondary outcome
All Cause Hospitalization/Mortality
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misook L Chung, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family SWaP intervention in people with Heart Failure, run by Misook L. Chung at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.