- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01145742
Controlling Hypertension in Diabetes- Feasibility Study (COACH-D)
10. december 2018 opdateret af: Diane Mckee, Albert Einstein College of Medicine
A Collaborative Approach to Control Hypertension in Diabetes
Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control.
There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system.
We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings.
Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals.
There are three specific aims.
First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each.
Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention.
Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care.
Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures.
We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients.
This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Bronx, New York, Forenede Stater, 10705
- Albert Einstein College of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- type 2 diabetes,
- BP above 140/90 on two health center visits,
- home touch tone phone
Exclusion Criteria:
- dementia,
- homelessness,
- language other than English or Spanish
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: self-management support and BP telemonitoring
collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors
|
self-management support and telemonitoring of BP and blood glucose
|
|
Ingen indgriben: usual care
usual primary care management of BP. lipids, and glucose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood pressure
Tidsramme: baseline and 6 months
|
Change in blood pressure, measured at partipants' homes, between baseline and 6 months
|
baseline and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemoglobin A1c
Tidsramme: baseline and 6 months
|
Change in A1c from baseline to 6 months
|
baseline and 6 months
|
|
LDL Cholesterol
Tidsramme: baseline and 6 months
|
Change in LDL cholesterol from baseline to 6 months
|
baseline and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Melissa Diane McKee, MD, MS, Albert Einstein College of Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2006
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
15. juni 2010
Først indsendt, der opfyldte QC-kriterier
16. juni 2010
Først opslået (Skøn)
17. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2006-232
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 .