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Kaiser Permanente Evaluation of Medically-Tailored Meals in Adults With Chronic Medical Conditions at High Readmission Risk (KP NOURISH) Study
This study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).
For the KP NOURISH Study, eligible members hospitalized within participating Kaiser Permanente Northern California medical centers will be identified and screened electronically and pre-randomized to 1 of 3 arms (medically tailored meals alone vs. medically tailored meals with remotely delivered enhanced nutritional counseling sessions vs. usual care). Patients enrolled in the medically tailored meals arm will receive 1 medically-tailored meal per day for 10 weeks after hospital discharge. Patients enrolled in the medically tailored meals with enhanced nutritional counseling arm will receive 1 medically-tailored meal per day for 10 weeks after discharge with up to 3 remotely delivered nutritional counseling sessions with a registered dietician nutritionist during the same time period. Patients enrolled in the usual care arm will continue to receive their typical standard of care management. All enrolled patients will complete a questionnaire for patient-reported outcomes (i.e., self-efficacy, social isolation, patient satisfaction, and caring science domains) at baseline and at 10 weeks after discharge and followed electronically for total resource utilization and 30-, 60-, and 90-day outcomes.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Kaiser Permanente Northern California
Oakland, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
Kaiser Permanente Northern California
San Rafael, California, United States
Kaiser Permanente Northern California
Santa Clara, California, United States
Kaiser Permanente Northern California
Santa Rosa, California, United States
Start Date
April 27, 2020
Primary Completion Date
September 29, 2021
Completion Date
September 29, 2021
Last Updated
December 22, 2021
2,000
ACTUAL participants
Medically tailored meals
OTHER
Lead Sponsor
Kaiser Permanente
NCT07484009
NCT07191730
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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