Heart Failure
Conditions
Brief summary
The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.
Interventions
OTHERHome-delivered meals and short-term dietary counseling
Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
OTHERStudy -defined standard of care
Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Due to the nature of the intervention, participants, dietitians, and site coordinators can't be blinded. However, the investigators and outcome assessors will be blinded
Intervention model description
Two-arm study: active intervention vs study-defined standard of care
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans enrolled in a VHA facility * Hospitalized ( 24 hours) with new HF or worsening chronic HF * Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed) * Able and willing to provide informed consent and perform study activities
Exclusion criteria
* Food allergies or intolerances that cannot be accommodated by study diet * On dialysis or estimated glomerular filtration rate \<30 at randomization * Serum potassium (non-hemolyzed) \>6.0 mmol/L during index hospitalization * Heart transplant or active transplant listing * Left ventricular assist device present or anticipated \<6 months * Malignancy or other non-cardiac condition limiting life expectancy to \<12 months * Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet * Lack of space to store food for a week or equipment to prepare food * Severe cognitive impairment (SLUMS score \<20, or \<19 if less than high school education completed) * Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen) * Body mass index \>50 kg/m2 * Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life | within 6 weeks post-index hospital discharge | All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown: 1. Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied. 2. Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5. The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DAOH at 6 months post-discharge | 6 months post-discharge | This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden. |
Countries
United States
Contacts
CONTACTYuan Huang
CONTACTShirley Joyner
STUDY_CHAIRScott L. Hummel, MD
VA Ann Arbor Healthcare System, Ann Arbor, MI
Outcome results
None listed