Heart FailureNCT04351880
Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
A study testing Medically Tailored Meals in people with Heart Failure and Copd, run by Kaiser Permanente at 2 sites in United States.
Trial summary
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Copd, Liver Failure
- What is being tested?
- Medically Tailored Meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2020to 31 Dec 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
- Age 18 or older, with no upper age limit
- Hospitalized at Saint Joseph Hospital or Good Samaritan Medical Center with the anticipation that they will be discharged home
- Member of a KP health plan
- Have one or more of the following conditions:
- Heart failure
- Cancer
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- End-stage renal disease (ESRD)/chronic renal disease
- Chronic obstructive pulmonary disease (COPD)
- Diabetes Mellitus
- Chronic liver disease/cirrhosis
Who cannot join
- Patient discharged to a nursing home, an assisted living facility, or another setting where meals are institutionally provided
- Patient has a health condition which is incompatible with the diet choices offered by Project Angel Heart (PAH - food service vendor)
- Patient refuses the type of meal best for their medical condition
- Patient has dementia
- Patient is pregnant or hospitalized peri-partum
- Patient is an active participant in a PAH program or another meal program
Show all 11Show fewer
- Patient is unable to speak English or Spanish
- PAH unable to deliver meals due to patient not being in PAH service area
- Patient was discharged from the hospital within 24 hours of admission
- Patient whose household member has enrolled in the Meals MATTER study
- Patient discharged to hospice care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St Joseph's Hospital
Denver, Colorado, 80218
Good Samaritan Medical Center
Lafayette, Colorado, 80026
About this study
Official title: Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.
Read the detailed description
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.
The Investigators propose a research study with four Specific Aims:
Specific Aim 1: To determine if MTM provided post hospitalization for 4 weeks to patients with one or more of seven chronic health conditions will decrease depression/anxiety measured by the Hospital Anxiety and Depression Scale (HADS) at 60 days in comparison to meals provided for 2 weeks to members discharged from two hospitals.
Hypothesis 1: Patients receiving meals for 4 weeks will have a clinically significant increase in their HADS score at 60 days compared to those receiving meals for 2 weeks.
Specific Aim 2: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will improve general well-being and functional status measured by Katz's Activities of Daily Living (ADL).
Hypothesis 2: Patients receiving meals for 4 weeks will have a clinically significant increase in their sense of well-being and ADLs at 60 days compared to those receiving meals for 2 weeks.
Specific Aim 3: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will decrease a composite outcome of rehospitalizations and emergency department (ED) visits at 60 days in comparison to: a) meals provided for 2 weeks to members discharged from two hospitals; and b) a concurrent prospective control group not receiving meals at two other KPCO-contracted hospitals.
Hypothesis 3: Patients receiving meals for 4 weeks will have a decreased composite rate of rehospitalizations and ED visits at 60 days compared to those receiving meals for 2 weeks or the non-randomized control group.
Specific Aim 4: To determine the feasibility, acceptability and scalability of the Meals Matter Program to KP members, their households, and hospital leadership and staff.
- Conditions
- Heart Failure, Copd, Liver Failure, Diabetes Mellitus, Cancer, End Stage Renal Disease
- Being tested
- Medically Tailored Meals
- Keywords
- medically tailored meals, chronic conditions, food service
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Liver Failure, Diabetes Mellitus, Neoplasms, Kidney Failure, Chronic, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored MealsOther
Compare 2 and 4 weeks of meal delivery
| Study group | Role | What they receive |
|---|---|---|
| Meals - 2 weeks | Active comparator | Receive meal delivery for 2 weeks (1 meal per day for a total of 14 days). The medically tailored meal ordered for each participant will depend on their medical conditions. Receives: Other: Medically Tailored Meals |
| Meals - 4 weeks | Active comparator | Receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). The medically tailored meal ordered for each participant will depend on their medical conditions. Receives: Other: Medically Tailored Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.
Measured: A change in score from baseline to 60 days
Secondary outcomes (2)
Functional Status measured through the Katz Activities of Daily Living Scale
Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome.
Measured: A change in score from baseline to 60 days
Re-hospitalization and Emergency Department Visits
Measured through time of discharge through re-hospitalization or Emergency Department visit
Measured: 60 days from hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start16 Apr 2020
- Primary completion8 Sep 2021
- Study completion31 Dec 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 is a randomized trial to compare two approaches to meal delivery. Group 1 will receive meal delivery for 2 weeks (1 meal per day for a total of 14 days) and Group 2 will receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). A concurrent propensity matched control group which will not receive an intervention will also be used.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca S Boxer, MD, MS, Principal investigator, KP Institute for Health ResearchJohn Steiner, MD, MPH, Study director, KP Institute for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351880
- Sponsor's protocol ID
- IRB-1556587
- Status last verified
- Feb 2022
- First submitted
- 14 Apr 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
- ClinicalTrials.gov ID
- NCT04351880
- Acronym / sponsor ID
- IRB-1556587
- Conditions
- Heart Failure, Copd, Liver Failure, Diabetes Mellitus, Cancer, End Stage Renal Disease
- Keywords
- medically tailored meals, chronic conditions, food service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Apr 2020 (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.
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.
Detailed description
The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.
The Investigators propose a research study with four Specific Aims:
Specific Aim 1: To determine if MTM provided post hospitalization for 4 weeks to patients with one or more of seven chronic health conditions will decrease depression/anxiety measured by the Hospital Anxiety and Depression Scale (HADS) at 60 days in comparison to meals provided for 2 weeks to members discharged from two hospitals.
Hypothesis 1: Patients receiving meals for 4 weeks will have a clinically significant increase in their HADS score at 60 days compared to those receiving meals for 2 weeks.
Specific Aim 2: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will improve general well-being and functional status measured by Katz's Activities of Daily Living (ADL).
Hypothesis 2: Patients receiving meals for 4 weeks will have a clinically significant increase in their sense of well-being and ADLs at 60 days compared to those receiving meals for 2 weeks.
Specific Aim 3: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will decrease a composite outcome of rehospitalizations and emergency department (ED) visits at 60 days in comparison to: a) meals provided for 2 weeks to members discharged from two hospitals; and b) a concurrent prospective control group not receiving meals at two other KPCO-contracted hospitals.
Hypothesis 3: Patients receiving meals for 4 weeks will have a decreased composite rate of rehospitalizations and ED visits at 60 days compared to those receiving meals for 2 weeks or the non-randomized control group.
Specific Aim 4: To determine the feasibility, acceptability and scalability of the Meals Matter Program to KP members, their households, and hospital leadership and staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a randomized trial to compare two approaches to meal delivery. Group 1 will receive meal delivery for 2 weeks (1 meal per day for a total of 14 days) and Group 2 will receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). A concurrent propensity matched control group which will not receive an intervention will also be used.
| Arm | Type | Receives |
|---|---|---|
| Meals - 2 weeks | Active comparator | Other: Medically Tailored MealsReceive meal delivery for 2 weeks (1 meal per day for a total of 14 days). The medically tailored meal ordered for each participant will depend on their medical conditions. |
| Meals - 4 weeks | Active comparator | Other: Medically Tailored MealsReceive meal delivery for 4 weeks (1 meal per day for a total of 28 days). The medically tailored meal ordered for each participant will depend on their medical conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older, with no upper age limit
- Hospitalized at Saint Joseph Hospital or Good Samaritan Medical Center with the anticipation that they will be discharged home
- Member of a KP health plan
- Have one or more of the following conditions:
Key exclusion criteria (11 listed)
- Patient discharged to a nursing home, an assisted living facility, or another setting where meals are institutionally provided
- Patient has a health condition which is incompatible with the diet choices offered by Project Angel Heart (PAH - food service vendor)
- Patient refuses the type of meal best for their medical condition
- Patient has dementia
- Patient is pregnant or hospitalized peri-partum
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 2 and 4 weeks of meal delivery | Other | Meals - 2 weeks, Meals - 4 weeks |
Primary outcome
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
Time frame: A change in score from baseline to 60 days
Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.
2 secondary outcomes
Functional Status measured through the Katz Activities of Daily Living Scale
Time frame: A change in score from baseline to 60 days
Re-hospitalization and Emergency Department Visits
Time frame: 60 days from hospital discharge
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 17 Feb 2022.
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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.
Rebecca S Boxer, MD, MS principal investigator
KP Institute for Health Research
John Steiner, MD, MPH study director
KP Institute for Health Research
2 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 Copd, run by Kaiser Permanente at 2 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 10 inclusion and 11 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale (time frame: A change in score from baseline to 60 days). 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 17 Feb 2022.