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Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

15. juni 2016 opdateret af: Julien Dedier, Boston Medical Center

Interactive Multirisk-Factor Intervention for HTN Blacks

The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:

  1. TLC-HTN-AA use will improve medication regiment adherence
  2. TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
  3. TLC-HTN-AA will improve levels of regular exercise
  4. Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

337

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Medical Information Systems Unit/Boston Medical Center

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

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study
  • have a physician diagnosis of hypertension
  • be African American by self-report
  • be 35 years of age or older
  • be prescribed at least one medication for hypertension
  • have poorly controlled blood pressure
  • be non-adherent to at least one hypertensive medication
  • understand spoken English
  • have a home telephone

Exclusion Criteria:

  • patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate
  • patients with a terminal illness
  • patients with severe medical or psychiatric illness
  • patients with cognitive difficulty

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Automated Telephone Program
The intervention was a totally automated, computer-based, interactive telephone counseling system called Telephone- Linked-Care, designed to monitor, educate, and counsel African-American adults with hypertension and to provide summary data regularly to the patient's primary care provider.
Adfærdsmæssigt: Automated Telephone Program
The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.). These participants also received the same health behavior education those in the control condition received.
Adfærdsmæssigt: Health Behavior Education
Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).
Placebo komparator: Health Behavior Education
The comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care.
Adfærdsmæssigt: Health Behavior Education
Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period
Tidsramme: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
8 months
2-consumption of more than 5 servings of fruits and vegetables a day, less than 30% of calories from fat, and less than 2400 mg of sodium a day at the end of the intervention period
Tidsramme: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
8 months
3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
Tidsramme: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
8 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1-TLC-HTN-AA use will reduce the mean blood pressure and the proportion of the treatment group having uncontrolled hypertension at the end of the intervention period
Tidsramme: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
8 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Medical Center

Efterforskere

  • Ledende efterforsker: Robert Friedman, MD, Boston Medical Center
  • Studieleder: Jeffrey Migneault, PhD, Boston University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. oktober 2001

Primær færdiggørelse (Faktiske)

1. august 2007

Studieafslutning (Faktiske)

1. august 2007

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier

12. september 2005

Først opslået (Skøn)

21. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HL 69395

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

Kliniske forsøg med Automated Telephone Program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo, DR of

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner