Heart FailureKP NOURISHNCT05166525
Kaiser Permanente Evaluation of Medically Tailored Meals in Adults With Medical Conditions at High Readmission Risk
A study testing Medically tailored meals in people with Heart Failure and Chronic Kidney Diseases, run by Kaiser Permanente at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Kidney Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Medically tailored meals
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Apr 2020to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized at Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
- Kaiser Permanente member at admission
- Has a prior history of at least one of the following:
- Heart failure
- Diabetes mellitus
- Chronic kidney disease
Who cannot join
- Receiving primary care at Kaiser Permanente facilities outside of Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
- Language interpreter needed
- Admitted from skilled nursing facility or nursing home
- Homeless at admission
- Residence outside the geographic area covered by the medically tailored meals vendors
- Prior history of organ transplant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kaiser Permanente Northern California
Oakland, California, 94611
Kaiser Permanente Northern California
San Francisco, California, 94115
Kaiser Permanente Northern California
San Rafael, California, 94903
Kaiser Permanente Northern California
Santa Clara, California, 95051
Kaiser Permanente Northern California
Santa Rosa, California, 95403
About this study
Official title: 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).
Read the detailed description
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.
- Being tested
- Medically tailored meals
- Keywords
- Medically Tailored Meals, Nutritional Counseling, Food is Medicine
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically tailored mealsOther
Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care
| Study group | Role | What they receive |
|---|---|---|
| Medically tailored meals only | Active comparator | Receive medically-tailored meals only (1 meal per day for total of 10 weeks) customized to the participant's nutrition-sensitive medical condition(s). Receives: Other: Medically tailored meals |
| Medically tailored meals plus enhanced nutritional counseling | Active comparator | Receive medically-tailored meals only (1 meal per day for total of 10 weeks) with up to 3 remotely delivered enhanced nutritional counseling sessions that are customized to the participant's nutrition-sensitive medical condition(s). Receives: Other: Medically tailored meals |
| Usual care | Placebo comparator | Receive usual standard of care. Receives: Other: Medically tailored meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day hospitalization for any cause
Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.
Measured: 90-days after discharge from the index hospitalization
Secondary outcomes (8)
90-day hospitalization related to heart failure
Occurrence of hospitalization for heart failure within 90 days after discharge from the index hospitalization.
Measured: 90-days after discharge from the index hospitalization
90-day hospitalization related to diabetes
Occurrence of hospitalization for a diabetes-related complication within 90 days after discharge from the index hospitalization.
Measured: 90-days after discharge from the index hospitalization
90-day all-cause mortality
Occurrence of death from any cause within 90 days after discharge from the index hospitalization.
Measured: 90-days after discharge from the index hospitalization
Patient-reported outcomes
Isolation measured on Likert scale (1-5) for 4 different questions related to feelings of isolation. Self-efficacy measured on Likert scale (1-10) for 4 different questions related to feelings of self-efficacy in maintaining healthy dietary habits. Caring science measured on Likert scale (1-5) one question of the impact of meal delivery programs on feelings of being cared for through food.
Measured: 10 weeks after discharge from the index hospitalization
Emergency department visit for any cause
Occurrence of an emergency department visit for any reason within 90 days after discharge from the index hospitalization.
Measured: 30-, 60- and 90-days after discharge from the index hospitalization
30-day hospitalization for any cause
Occurrence of hospitalization for any reason within 30 days after discharge from the index hospitalization.
Measured: 30-days after discharge from the index hospitalization
60-day hospitalization for any cause
Occurrence of hospitalization for any reason within 60 days after discharge from the index hospitalization.
Measured: 60-days after discharge from the index hospitalization
90-day composite of hospitalization for any cause, emergency department visit for any cause or all-cause death
Occurrence of hospitalization, emergency department visit, or death from any cause within 90 days after discharge from the index hospitalization.
Measured: 90-days after discharge from the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start27 Apr 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan S Go, MD, Principal investigator, Kaiser Permanente Northern California Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166525
- Sponsor's protocol ID
- 1527031
- Acronym
- KP NOURISH
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaiser Permanente Evaluation of Medically-Tailored Meals in Adults With Chronic Medical Conditions at High Readmission Risk (KP NOURISH) Study
- ClinicalTrials.gov ID
- NCT05166525
- Acronym / sponsor ID
- KP NOURISH / 1527031
- Keywords
- Medically Tailored Meals, Nutritional Counseling, Food is Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Medically tailored meals only | Active comparator | Other: Medically tailored mealsReceive medically-tailored meals only (1 meal per day for total of 10 weeks) customized to the participant's nutrition-sensitive medical condition(s). |
| Medically tailored meals plus enhanced nutritional counseling | Active comparator | Other: Medically tailored mealsReceive medically-tailored meals only (1 meal per day for total of 10 weeks) with up to 3 remotely delivered enhanced nutritional counseling sessions that are customized to the participant's nutrition-sensitive medical condition(s). |
| Usual care | Placebo comparator | Other: Medically tailored mealsReceive usual standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized at Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
- Kaiser Permanente member at admission
- Has a prior history of at least one of the following:
Key exclusion criteria (6 listed)
- Receiving primary care at Kaiser Permanente facilities outside of Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
- Language interpreter needed
- Admitted from skilled nursing facility or nursing home
- Homeless at admission
- Residence outside the geographic area covered by the medically tailored meals vendors
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 |
|---|---|---|
| Medically tailored mealsCompare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care | Other | Medically tailored meals only, Medically tailored meals plus enhanced nutritional counseling, Usual care |
Primary outcome
90-day hospitalization for any cause
Time frame: 90-days after discharge from the index hospitalization
Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.
8 secondary outcomes
90-day hospitalization related to heart failure
Time frame: 90-days after discharge from the index hospitalization
90-day hospitalization related to diabetes
Time frame: 90-days after discharge from the index hospitalization
90-day all-cause mortality
Time frame: 90-days after discharge from the index hospitalization
Patient-reported outcomes
Time frame: 10 weeks after discharge from the index hospitalization
Emergency department visit for any cause
Time frame: 30-, 60- and 90-days after discharge from the index hospitalization
30-day hospitalization for any cause
Time frame: 30-days after discharge from the index hospitalization
60-day hospitalization for any cause
Time frame: 60-days after discharge from the index hospitalization
90-day composite of hospitalization for any cause, emergency department visit for any cause or all-cause death
Time frame: 90-days after discharge from the index hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- 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.
Alan S Go, MD principal investigator
Kaiser Permanente Northern California Division of Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically tailored meals in people with Heart Failure and Chronic Kidney Diseases, run by Kaiser Permanente at 5 sites 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 6 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 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
90-day hospitalization for any cause (time frame: 90-days after discharge from the index hospitalization). 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 22 Dec 2021.