Heart Failure
Conditions
Keywords
indigenous, food is medicine, Traditional Foods, Nutrition Security, Navajo
Brief summary
Study subjects with heart failure will receive either pre-prepared, home-delivered DASH/SRD-compliant meals incorporating local Navajo traditional foods or usual care for 30 days (14 meals weekly).
Detailed description
The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the U.S. \[1\] Heart failure, in particular, causes significant morbidity and mortality in Navajo Nation. For many Navajo patients, similar to other American Indian populations, food insecurity is a major driver of health disparities. \[2\]\[3\] In fact, qualitative data from our heart failure patient advisory committee have found that 89% of patients with heart failure believe nutrition insecurity is a major barrier to optimal health. Dietary factors are believed to be an important cause of hospitalizations in patients with heart failure and cardiovascular outcomes. There is increasing evidence that direct dietary support, such as produce prescription or provision of medically tailored meals may improve cardiovascular outcomes and disease-specific quality of life. Furthermore, there has been an increased focus in Indigenous communities to reclaim traditional indigenous foods to improve health. However, more evidence of the benefit of traditional Indigenous foods for cardiovascular health is needed. We, therefore, in discussion with community members and tribal partners at two Indian Health Service (IHS) sites in Navajo Nation, will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation. This study will include two phases, with a phase I pilot feasibility study, followed by phase II-a comparativeness effectiveness randomized controlled trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care. For phase I, we will conduct a one-arm pilot trial of the MUTTON-HF intervention to determine 1) feasibility of the intervention and outcome assessment and 2) acceptability of the intervention and 3) fidelity of the intervention. We will enroll 20 patients to receive medically tailored meals (14 meals weekly) for 30 days to inform the phase II comparativeness effectiveness trial. Phase I outcomes will include implementation outcomes such as feasibility and acceptability of the intervention including the various delivery mechanisms and meals as measured by quantitative (i.e. % meals delivered and % meals received by patient) and qualitative methods, of outcome assessment including surveys and laboratory evaluation (% with completed outcome assessment), and fidelity of intervention as measured by quantitative (% meals consumed). We will additionally measure feasibility and acceptability of supporting local food systems by measuring % meals with locally sourced produce and meat, and % sourced from Navajo farmers and ranchers specifically. We will also explore implementation outcomes with community partners including farmers, growers, ranchers, food pantry.
Interventions
Patients will receive medically-tailored meals incorporating local traditional Navajo foods
Sponsors
Indian Health Service (IHS)
Brigham and Women's Hospital
American Heart Association
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years * ICD I50\* diagnosis * Clinical encounter in last 12 months * Primary care physician at the two IHS sites * Hospitalization (any-cause) within last 12 months
Exclusion criteria
* Hospice care * Living in acute rehabilitation or skilled nursing facility * Living outside the Gallup Service Unit (outside 50-mile catchment area)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percentage of meals successfully received by the patient | 30 days | Proportions of meals that were successfully picked up or received by the patient. We have determined that \>70% would count as success/feasibility of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cultural Connectedness Scale-California | Baseline, 30 Days | The Cultural Connectedness Scale (CCS) was developed in Canada by First Nations/Indigenous persons for First Nations/Indigenous persons. The 29-item CCS consists of three sub-scales: identity, traditions, and spirituality. This scale ranges from 0-40, with 40 indicating higher levels of cultural connectiveness. |
| Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | Baseline, 30 Days | This is a validated score for evaluating quality of life and symptom measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status. |
| USDA Adult Food Security: Six Item short Form survey | Baseline, 30 Days | The six-item short form of the survey module and the associated Six-Item Food Security Scale were developed by researchers at the National Center for Health Statistics in collaboration with Abt Associates Inc. |
| Hospitalization or Emergency Department Visit | 90 Days | Hospitalization or Visit to Emergency Department (All-cause) |
| Laboratory Biomarker Data | Baseline, 30 Days | Albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP |
| Weight/Body Mass Index | Baseline, 30 Days | weight and BMI |
| Emergency Room Visits | 90 Days | ER visits: All cause |
| ER visits or hospitalizations | 180 days | All cause |
| ER visit for Heart Failure | 90 Days | ER visit for volume overload or HF symptoms |
| Heart Failure Hospitalizations | 90 days | Hospitalizations for heart failure specifically |
| Feasibility: Percentage of meals delivered successfully to the Gallup Food Pantry | 30 days | Proportions of meals that were successfully delivered to the Gallup Food Pantry by our community partner and Native-run Kitchen |
| Feasibility of Intervention: Delivery/Pick-Up | 30 days | We will survey patients post-intervention with question to assess feasibility: I would rate getting the meals (either picking up or delivery): Very easy, Somewhat easy, Neither easy nor difficult, Somewhat difficult, Very difficult. |
| Acceptability of the Intervention (AIM) Measure | 30 days | We will evaluate acceptability of the intervention among the patients through quantitative assessment using the validated acceptability of the intervention (AIM) measure |
| Net Promoter Score | 30 days | We will also assess acceptability of the intervention through assess the Net Promoter Score (i.e. how likely is it that you would recommend this program to a community member?), which is a scale 1 (highly unlikely) to 10 (highly likely). |
| Fidelity: Consumption | 30 days | Patients will also rate meals from 1-5 and the amount of the meal they consumed (none \[or only a few bites\], less than half, about half, most, or all) |
| Qualitative measures of feasibility and acceptability | 30 days | We will also perform semi-structured interviews of patients to assess feasibility and acceptability through qualitative methods. Semi-structured interviews will be guided by the Consolidated Framework for Implementation Research (CFIR), and we will explore multiple constructs within each CFIR domain that are hypothesized by the study team and based on existing literature to be relevant to acceptability and feasibility of the program |
| Feasibility of Supporting Local Food Systems | 30 days | We will assess feasibility among our community partners by assessing the validated feasibility of the intervention measure (FIM) among our food pantry partners. |
| Feasibility: Local Food Sourcing | 30 days | We will also assess the % of meals that include locally sourced ingredients, % of meals sourced by Native suppliers/farmers (produce), % of meals soured by Native ranchers (meat) |
| Feasibility of Outcome Assessment | 30 days | We will determine the proportion of patients that completes baseline, as well as post-implementation survey and laboratory data. We will consider ≥ 80% completion rates as a success. |
| Fidelity of Intervention | 30 days | We will assess fidelity of the intervention by evaluating: * We will have patients' complete food diaries for 3 days during week 1 and week 4 of the intervention. * % of meals consumed: Patients will also fill out meal cards weekly with percent consumed (None \[or a few bites\], ¼, ½, ¾, all \[or nearly all\]). § We will stratify meals consumed by whether the meal used traditional Diné ingredients or not. * We will additionally survey participants post-intervention the following: * In terms of leftovers, how much of the meals were not eaten and had to be thrown out? (all, most, about half, less than half, none). * We will consider ≥ 70% meals consumed (at least ½ or more of the meal) or ≥70% indicating they ate most or more of the meals as a success |
| Adoption of Intervention | 30 days | We will survey participants post-intervention the following using a Likert scale: * How likely is it that this program will change your diet to be healthier moving forward? (very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely) * How likely is it that you will add any of the meals or recipes from this program to your on-going diet in the future? (very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely) |
| Diet Quality | Baseline and 30 days | We will assess diet quality using the 10-item DSQ \[10\] with an addition question to assess traditional Dine food intake (During the past month, how often did you eat traditional Diné foods (such as blue corn mush, steamed, roasted or dried corn, sumac berries, mutton, local varieties of squash or beans) at baseline and at the end of the intervention. |
| Physical Activity | Baseline and 30 days | We will evaluate how much physical activity/exercise patients are participating in weekly at baseline, and at 30 days by asking patients to estimate the number of minutes weekly that they are participating in formal exercise or physical activity. |
| General Health Status | Baseline and 30 days | We will evaluate patients' general health status using a single general health status question (would you say that in general your health is excellent, very good, good, fair, or poor) at baseline and post-intervention |
| KCCW12-PL Physical Limitation Score | 30 days | Subsection of KCCQ-12 Summary |
| KCCQ12-PL Physical Limitation Score | 30 days | Subsection of KCCQ12 looking at physical limitation |
| KCCQ12-SF Symptom Frequency Score | 30 Days | Subsection of KCCQ-12 looking at frequency of symptoms |
| KCCQ-QL | 30 Days | Subsection of KCCQ-12 that looks at quality of life |
| KCCQ-SL Social Limitation Score | 30 days | Subsection of KCCQ-12 looking at social limitation |
| Acceptability: Taste | 30 days | Patients will also be surveyed post-intervention the following questions to assess acceptability: How would you rate the meals overall, in terms of taste (excellent, good, average, below average, bad? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication and Medical Therapy Adherence | 30 days | Additional exploratory outcomes will prescription rates for all medication as well as guideline-directed medical therapy specifically (for heart failure with reduced ejection fraction this would include ACEi/ARB/ARNI, Beta-blocker, SGLT2 inhibitors, and mineralocorticoid receptor antagonist; for HFpEF this would include SGLT2 inhibitors). |
Countries
United States
Outcome results
None listed