- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00005706
Urban African-American Community Hypertension Control
Studieoversikt
Status
Detaljert beskrivelse
BACKGROUND:
This population based study was significant because it offered a multidisciplinary, community HBP control program to help close the gap in health status for African Americans. The study was conducted in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.
DESIGN NARRATIVE:
The two and a half year intervention trial sought to extend and test the generalizability of prior work in a similar inner city African American community, which demonstrated the efficacy of planned health education programs that were culturally-sensitive, community-based and owned, and built upon appropriate behavioral and community activation theory and principles, in improving the control of HBP and decreasing related morbidity and mortality.
Five hundred men and 500 women were recruited from households in neighborhood blocks randomly assigned to a more or less intensive educational-behavioral intervention. Both groups received usual medical care, community HBP education, and HBP patient education materials. In addition, the more intensive group received 1) individualized educational counseling sessions with the CHW to increase understanding of HBP and to address barriers to control of HBP; 2) outreach and follow-up to address inadequate health care resources and health behavior related skills through interim monitoring and education "booster" sessions; and 3) mobilization of social support from a family member/friend identified by the participant as the primary source of daily reinforcement.
Statistical analysis focused on BP change in all adults with HBP on randomized blocks whether or not they participated in either of the intervention groups (program effectiveness), as well as BP change in all adults participating in the two interventions regardless of their level of compliance (intervention efficacy). In addition, the analysis focused on differences in the two groups regarding individuals' adherence to HBP lowering recommendations to enter/re-enter care, remain in care, modify lifestyle, and take HBP medication. Multiple regression was done to determine the contribution of the changes in the major independent variables (perceived barriers, use of health care resources and health care skills, and social support) to changes in the outcome and intervening variables which included adherence to HBP lowering recommendations.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Studietype
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Bone LR, Hill MN, Stallings R, Gelber AC, Barker A, Baylor I, Harris EC, Zeger SL, Felix-Aaron KL, Clark JM, Levine DM. Community health survey in an urban African-American neighborhood: distribution and correlates of elevated blood pressure. Ethn Dis. 2000 Winter;10(1):87-95.
- Kim MT, Hill MN, Bone LR, Levine DM. Development and testing of the Hill-Bone Compliance to High Blood Pressure Therapy Scale. Prog Cardiovasc Nurs. 2000 Summer;15(3):90-6. doi: 10.1111/j.1751-7117.2000.tb00211.x.
- Clark JM, Bone LR, Stallings R, Gelber AC, Barker A, Zeger S, Hill MN, Levine DM. Obesity and approaches to weight in an urban African-American community. Ethn Dis. 2001 Fall;11(4):676-86.
- Gelber AC, Wigley FM, Stallings RY, Bone LR, Barker AV, Baylor I, Harris CW, Hill MN, Zeger SL, Levine DM. Symptoms of Raynaud's phenomenon in an inner-city African-American community: prevalence and self-reported cardiovascular comorbidity. J Clin Epidemiol. 1999 May;52(5):441-6. doi: 10.1016/s0895-4356(99)00015-3.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
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
- 4915
- R01HL051111 (U.S. NIH-stipend/kontrakt)
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