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

4 oktober 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

174

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02130
        • Brigham and Women's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hemoglobin A1c
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence to daily medications
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2013

Primärt slutförande (Faktisk)

1 april 2018

Avslutad studie (Faktisk)

1 juni 2019

Studieregistreringsdatum

Först inskickad

17 april 2015

Först inskickad som uppfyllde QC-kriterierna

13 september 2015

Första postat (Uppskatta)

15 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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