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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02118
- Medical Information Systems Unit/Boston Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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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).
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Placebo-vergelijker: 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.
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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).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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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
Tijdsspanne: 8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
Tijdsspanne: 8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Robert Friedman, MD, Boston Medical Center
- Studie directeur: Jeffrey Migneault, PhD, Boston University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HL 69395
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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