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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Study-defined standard of care |
|
| Home-delivered meals and short-term dietary counseling | Experimental | Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-delivered meals and short-term dietary counseling | Other | Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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:
The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome. | within 6 weeks post-index hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| DAOH at 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. | 6 months post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Huang | Contact | (203) 737-7966 | Yuan.Huang1@va.gov | |
| Shirley Joyner | Contact | (203) 932-5711 | Shirley.Joyner@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Scott L. Hummel, MD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105-2303 | United States |
Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible
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Two-arm study: active intervention vs study-defined standard of care
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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
| Study -defined standard of care | Other | study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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