VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303, United States
NCT Number: NCT05996328
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48105-2303, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Time frame: 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:
The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Shirley Joyner
CONTACT
Yuan Huang
CONTACT
VA Office of Research and Development
Fed
Acronym: GOURMET-VA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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