CHW-intervensjon for å forbedre ernæringssikkerheten til pasienter med hypertensjon (HeartWell)
CHW-intervensjon for å forbedre ernæringssikkerheten til primærhelsepasienter med hypertensjon
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced CHW intervention in primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) that provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. The CHW nutrition intervention curriculum is tailored to the needs and preferences of a food-insecure population with limited resources. Nutrition education materials will be provided to participants, including a booklet of nutrition information and a summarized version of key points on a brochure that they can use as a quick reference when grocery shopping. Nutrition education will focus on reducing sodium, saturated fats, and added sugars and increasing fruits, vegetables, and whole grains. Much of the educational material is based on a traffic-light system. These topics are organized into four modules: nutrition label reading, grocery shopping, meal-planning, and healthy cooking.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Eligible to participate in the Massachusetts General Hospital CHW hypertension program (age 21 years or older, uncontrolled hypertension, patient at one of 5 participating primary care clinics; either identifies as a minoritized race/ethnicty or is low-income); speaks English or Spanish
Exclusion Criteria:
- declines participation in CHW hypertension program; does not speak English or Spanish
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Nutrition-enhanced CHW intervention
This intervention integrates a nutrition component into the Basic CHW hypertension intervention to address gaps in patients' knowledge, skills, and resources for consuming and sustaining a healthful diet. CHWs will administer a 4-part nutrition curriculum that is tailored to the needs and preferences of a food-insecure population with limited resources. The nutrition education materials provided to participants will include a booklet of nutrition information that will serve as the primary educational resource for CHW use with participants. |
CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management. |
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Aktiv komparator: Basic CHW intervention
The CHW provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring. All participants are provided home BP cuffs and remote monitoring free of charge. |
CHW provide usual care for hypertension management. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasiblity
Tidsramme: Baseline
|
Proportion of eligible participants enrolled in study |
Baseline
|
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Feasibility of CHW nutrition intervention (intervention arm only)
Tidsramme: 4 months
|
At least 70% participants complete at least 3 of 4 CHW nutrition education modules |
4 months
|
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Acceptability (intervention arm only)
Tidsramme: 4 months
|
Average of participants' ratings of intervention components on a 10-point scale. |
4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diet quality
Tidsramme: 4 months
|
Change in Healthy Eating Index-20 score |
4 months
|
|
Blood pressure
Tidsramme: 4 months
|
Change in systolic and diastolic blood presure |
4 months
|
|
Secondary feasibility (intervention arm only)
Tidsramme: 4 months
|
At least 70% participants complete 3 of 6 nutrition worksheets |
4 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Anne N Thorndike, MD, MPH, Massachusetts General Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024P000873
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified feasiblity, acceptability, diet quality, and blood pressure data will be shared. The data and details related to the analytic plan and study measures will be deposited in a publicly accessible data repository, such as the Harvard Dataverse, a NIH-approved Scientific Generalist Data Repository free to researchers inside and outside the Harvard community.
IPD-delingstidsramme
Analytic plans and details will be made available no later than the official publication date of a peer-reviewed article that includes the study results, and these will be available for at least 5 years after the study period ends. De-identified data from the study will be made publicly available through the data repository within 90 days of the closeout of the project and made available according to the Harvard Dataverse's data retention policy.
Tilgangskriterier for IPD-deling
In accordance with the data repository methods, completion of a data use agreement form, that stipulates data sharing under an IRB-approved protocol, will be required for accessing the data.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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