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Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico

4. oktober 2019 oppdatert av: Daniel Palazuelos, Brigham and Women's Hospital

Evaluation of a Community Health Worker Intervention on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico

This study evaluates the effectiveness of community health workers when added to routine care for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It does so by recording information on adherence to therapy, blood pressure and hemoglobin A1c while a non-governmental organization working in Mexico trains and introduces a community health worker program.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Compañeros en Salud (CES), an affiliate project of Partners in Health, has been working in the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the local Ministry of Health to rehabilitate and staff existing government primary care clinics. Each community's clinic is staffed by one CES project physician year-round. CES activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and hypertension. CES currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and consists of monthly in-clinic visits by primary care physicians.

Over 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health worker program called "Acompañantes" to its project communities to augment care of patients with NCDs. Acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of NCDs, their treatments, and adherence to therapy. The introduction of Acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The investigators' project will document their experience over this time, and for one year after introduction of the Acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.

Studietype

Observasjonsmessig

Registrering (Faktiske)

174

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02130
        • Brigham and Women's Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients with Diabetes Mellitus, Type 2, or Hypertension, taking daily therapy, living in one of seven study communities in rural Chiapas, Mexico.

Beskrivelse

Inclusion Criteria:

  • Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both
  • Daily medications required for patient's condition
  • Residence and receipt of therapy within the study catchment area
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • Known or suspected secondary hypertension
  • Known or suspected Type 1 diabetes
  • Pregnancy
  • Chronic use of glucocorticoids.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Patients with Diabetes or Hypertension
All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hemoglobin A1c
Tidsramme: Every-three months, until one year after all communities receive intervention
Percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay
Every-three months, until one year after all communities receive intervention
Systolic blood pressure
Tidsramme: Every-three months, until one year after all communities receive intervention
Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor
Every-three months, until one year after all communities receive intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence to daily medications
Tidsramme: Every-three months, until one year after all communities receive intervention
Self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions
Every-three months, until one year after all communities receive intervention
Diastolic blood pressure
Tidsramme: Every-three months, until one year after all communities receive intervention
Diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure
Every-three months, until one year after all communities receive intervention
Disease control
Tidsramme: Every-three months, until one year after all communities receive intervention
Diabetes and/or hypertension control. Disease control among patients with hypertension was defined according to Mexican national guidelines: blood pressure <140/90 mm Hg for patients with hypertension and no diabetes; blood pressure <130/80 mm Hg for patients with hypertension and diabetes and blood pressure < 150/90 mm Hg for patients over the age of 80. Disease control for patients with diabetes defined as glycated hemoglobin (HbA1c) < 7% per national guidelines.
Every-three months, until one year after all communities receive intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Studieleder: Patrick M Newman, MD, Brigham and Women's Hospital
  • Hovedetterforsker: Daniel Palazuelos, MD, MPH, Brigham and Women's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2013

Primær fullføring (Faktiske)

1. april 2018

Studiet fullført (Faktiske)

1. juni 2019

Datoer for studieregistrering

Først innsendt

17. april 2015

Først innsendt som oppfylte QC-kriteriene

13. september 2015

Først lagt ut (Anslag)

15. september 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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