- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00207194
Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks
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:
- TLC-HTN-AA use will improve medication regiment adherence
- TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
- TLC-HTN-AA will improve levels of regular exercise
- Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02118
- Medical Information Systems Unit/Boston Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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.
|
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.
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-jämförare: 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.
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: 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
Tidsram: 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
Tidsram: 8 months
|
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
|
8 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: 8 months
|
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
|
8 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Robert Friedman, MD, Boston Medical Center
- Studierektor: Jeffrey Migneault, PhD, Boston University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HL 69395
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Hypertoni
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Avslutad
-
NovartisAvslutad
-
NovartisAvslutadMETABOLISKT SYNDROM | HYPERTENSION | PRE-HYPERTENSIONFörenta staterna
-
Centre Chirurgical Marie LannelongueOkändKronisk trombo-embolisk pulmonell hypertension och pulmonell arteriell hypertensionFrankrike
-
NovartisAvslutadHYPERTENSION | HYPERKOLESTEROLEMIFörenta staterna
-
University Hospital, BonnRekryteringKardiomyopatier | Hypertoni, PortalTyskland
-
University Hospital, ToursAvslutadCirrhotic Portal HypertensionFrankrike
-
Assistance Publique - Hôpitaux de ParisAktiv, inte rekryterandeIntrahepatisk icke-cirrhotisk portalhypertoniFrankrike
-
Ain Shams UniversityAvslutad
Kliniska prövningar på Automated Telephone Program
-
Datascope Patient MonitoringAvslutadHjärthändelseFörenta staterna
-
HippocreatesRekryteringAllergiBelgien, Tyskland
-
Queen Astrid Military HospitalRekryteringVuxen militär personalBelgien
-
The University of Texas at DallasAvslutadStroke | Perifer neuropati | Kronisk hjärnskadaFörenta staterna
-
Mayo ClinicAvslutadMedfödd diafragmabråck | Neuralrörsdefekter | Tvilling till tvillingtransfusionssyndrom | Nedre urinvägsinfektionFörenta staterna
-
Diego BassaniCanadian Red CrossAvslutad
-
Cardica, IncAvslutadKranskärlssjukdomFörenta staterna
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)AvslutadLungsjukdom, kronisk obstruktivFörenta staterna
-
HippocreatesAvslutadAllergipollen | Allergi mot husdammBelgien
-
University of Maryland, BaltimoreThe Broad Foundation; University of Maryland, College Park; Baltimore VA... och andra samarbetspartnersAvslutadUlcerös kolit | Inflammatorisk tarmsjukdomFörenta staterna