- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03159533
Project IMPACT: CHW Intervention (IMPACT)
Project IMPACT: Community Health Care Worker (CHW) Intervention
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The Goal of this study is that:
- EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care;
- A combined EHR-CHW intervention will be more effective in improving hypertension control for South Asian patients compared to standard care and the EHR-based intervention
Investigators hope to implement and assess the efficacy of CHW-led coaching through promotion of team-based care and use of culturally tailored education to improve hypertension control and mitigate risk factors related to CVD among South Asian patients with uncontrolled hypertension. Study findings can provide translatable and scalable models for other limited English proficient communities.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10016
- New York University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
CHW Intervention
- Diagnosis of hypertension or at least two systolic blood pressure measurements of 140 mm Hg or greater, or at least two diastolic BP 90 mm Hg or greater in the past 12 months.
Focus Group
- Any clinical patients meeting the inclusion criteria for the CHW Intervention who participated in the CHW Intervention Pilot Round.
Exclusion Criteria:
- Pregnant patients are excluded.
- No children or vulnerable subjects will be enrolled in this study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: CHW Intervention
CHW lead Sessions Session1: BP and the Cardiovascular System Session 2: Nutrition and food labels Session 3: Physical Activity and Stress Management Session 4: CVD Risk factors: cholesterol, blood sugar, & Smoking Session 5: Health Communication, Healthcare access & Review
|
Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit.
At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW.
CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits.
The CHW will make necessary referrals to other services available in the community (i.e.
exercise classes, social services, mental health, tobacco cessation, etc.).
|
Placebo komparator: Control Group
Wait-list
|
4 education sessions beginning 6-12 months later.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months
Tidsramme: 6 Months
|
6 Months
|
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months
Tidsramme: 12 months
|
12 months
|
Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months
Tidsramme: 6 months
|
6 months
|
Percent of patients without hypertension having valid BP measurement, last 12 months
Tidsramme: 12 months
|
12 months
|
Percent of current hypertensive patients screened for diabetes in last year
Tidsramme: 12 months
|
12 months
|
Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity
Tidsramme: 12 months
|
12 months
|
Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year
Tidsramme: 12 months
|
12 months
|
Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-00969
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forhøjet blodtryk
-
BayerAfsluttet
-
National Taiwan University Hospital Hsin-Chu BranchRekrutteringHypertension, essentiel | Hypertension, maskeretTaiwan
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldAfsluttetIdiopatisk pulmonal arteriel hypertension | Kronisk tromboembolisk pulmonal hypertensionDet Forenede Kongerige
-
University of Kansas Medical CenterRekrutteringPulmonal arteriel hypertension | Pulmonal hypertension | Kronisk tromboembolisk pulmonal hypertension | Pulmonal hypertension på grund af venstre hjertesygdom | Pulmonal hypertension, primær, 4 | Pulmonal hypertension, primær, 2 | Pulmonal hypertension, primær, 3 | Pulmonal hypertension, primær | Pulmonal...Forenede Stater
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCAfsluttet
-
Centre Chirurgical Marie LannelongueUkendtKronisk trombo-embolisk pulmonal hypertension og pulmonal arteriel hypertensionFrankrig
-
University of South FloridaTrukket tilbagePulmonal arteriel hypertension | Familiær primær pulmonal hypertension | Idiopatisk pulmonal arteriel hypertension | Primær pulmonal hypertensionForenede Stater
-
Heidelberg UniversityMerck Sharp & Dohme LLCRekrutteringKronisk tromboembolisk pulmonal hypertension | Primær pulmonal arteriel hypertensionTyskland
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertension, essentielForenede Stater
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentUkendt
Kliniske forsøg med CHW Intervention
-
Public Health - Seattle and King CountyCenters for Disease Control and PreventionAfsluttet
-
University of FloridaAfsluttet
-
NYU Langone HealthNational Institute on Minority Health and Health Disparities (NIMHD)Afsluttet
-
University of MinnesotaIkke rekrutterer endnu
-
Johns Hopkins Bloomberg School of Public HealthMakerere UniversityAfsluttetSundhedsadfærd | Udnyttelse af sundhedsvæsenet | IncitamenterUganda
-
University of Texas Southwestern Medical CenterNational Institute on Drug Abuse (NIDA); National Institutes of Health...Afsluttet
-
St. John's Research InstituteNational Heart and Lung InstituteAfsluttetAkut koronarsyndromIndien
-
The University of Texas Health Science Center,...Cancer Prevention Research Institute of TexasAfsluttetLivmoderhalskræft | BrystkræftForenede Stater
-
Harvard School of Public Health (HSPH)Elton John AIDS Foundation; Management and Development for Health, Tanzania og andre samarbejdspartnereAfsluttetGraviditet | Mor-til-barn Overførsel af HIVTanzania
-
Columbia UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Afsluttet