- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02549495
Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Evaluation of a Community Health Worker Intervention on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02130
- Brigham and Women's Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Hemoglobin A1c
Časové okno: Every-three months, until one year after all communities receive intervention
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Percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay
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Every-three months, until one year after all communities receive intervention
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Systolic blood pressure
Časové okno: Every-three months, until one year after all communities receive intervention
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Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor
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Every-three months, until one year after all communities receive intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Adherence to daily medications
Časové okno: Every-three months, until one year after all communities receive intervention
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Self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions
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Every-three months, until one year after all communities receive intervention
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Diastolic blood pressure
Časové okno: Every-three months, until one year after all communities receive intervention
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Diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure
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Every-three months, until one year after all communities receive intervention
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Disease control
Časové okno: Every-three months, until one year after all communities receive intervention
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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.
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Every-three months, until one year after all communities receive intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Patrick M Newman, MD, Brigham and Women's Hospital
- Vrchní vyšetřovatel: Daniel Palazuelos, MD, MPH, Brigham and Women's Hospital
Publikace a užitečné odkazy
Obecné publikace
- Worster DT, Franke MF, Bazua R, Flores H, Garcia Z, Krupp J, Maza J, Palazuelos L, Rodriguez K, Newman PM, Palazuelos D. Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico. BMJ Open. 2020 Mar 8;10(3):e034749. doi: 10.1136/bmjopen-2019-034749.
- Newman PM, Franke MF, Arrieta J, Carrasco H, Elliott P, Flores H, Friedman A, Graham S, Martinez L, Palazuelos L, Savage K, Tymeson H, Palazuelos D. Community health workers improve disease control and medication adherence among patients with diabetes and/or hypertension in Chiapas, Mexico: an observational stepped-wedge study. BMJ Glob Health. 2018 Feb 15;3(1):e000566. doi: 10.1136/bmjgh-2017-000566. eCollection 2018.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2013P000711
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