- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03159533
Project IMPACT: CHW Intervention (IMPACT)
Project IMPACT: Community Health Care Worker (CHW) Intervention
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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New York
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New York, New York, Forente stater, 10016
- New York University School of Medicine
-
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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:
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
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4 education sessions beginning 6-12 months later.
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Hva måler studien?
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
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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
|
Samarbeidspartnere og etterforskere
Sponsor
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
- 16-00969
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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