- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00123045
Patient-Physician Partnership to Improve High Blood Pressure Adherence
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
BACKGROUND:
Hypertension is a common, chronic condition that contributes substantially to cardiovascular morbidity and mortality and resource use. Despite the proven efficacy of pharmacologic therapy and lifestyle modification for treatment of hypertension and prevention of its complications, most adults with established hypertension are uncontrolled. Limited access to medical care and financial barriers to obtaining medications play an important role; however, even among patients who receive regular care, blood pressure control remains suboptimal. Patient non-adherence to recommended therapies and problems in physician management of patients with hypertension are critical contributors to poor quality of care and negative health outcomes of hypertension. Of particular concern is the disproportionately high prevalence and incidence of hypertension and its complications among African Americans and socioeconomically disadvantaged persons. Ethnic and social class disparities in patient adherence are frequently based on financial, logistical, environmental, and cultural barriers that, while not unique to ethnic minorities and the poor, have a greater impact on these populations. Patient and physician interventions were designed to address the specific needs of inner city ethnic minorities and persons living in poverty. The study used a patient-centered, culturally tailored, education and activation intervention with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program delivered via an interactive CD-ROM, with tailored feedback to address physicians' individual communication skills needs.
DESIGN NARRATIVE:
The study used a patient-centered, culturally tailored, education and activation intervention with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program delivered via an interactive CD-ROM, with tailored feedback to address physicians' individual communication skills needs. Fifty physicians and 500 of their patients who had uncontrolled hypertension were recruited into a randomized controlled trial with a 2X2 factorial design. The 50 physicians were randomized to receive either a 2-hour CD-ROM based communication skills training or no training. Within each randomized physician, 10 patient-subjects were randomized to either minimal intervention or patient activation (community health worker visit and follow-up calls, plus photo novels and other mailed educational literature). Assessments of primary care appointment keeping, medication possession, medication taking, health status, satisfaction, and numerous other variables were made at baseline, 3 months, and 12 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Physicians - general internists and family physicians who see patients at least 20 hours per week at one of the participating study sites. Physicians are excluded if they intend to leave the practice within 12 months.
Patients - adults aged 18 years and older, with a diagnosis of hypertension (at least one claim with the ICD-9 code 401 in the preceding year), and able to provide contact information for themselves and at least one other person.
Patients who are too acutely ill, disoriented, or unresponsive to complete the baseline assessment and those with medical conditions that might limit their participation in the study (e.g., AIDS/HIV, schizophrenia, cancer (except skin), Alzheimer's or other form of dementia; end-stage renal disease, congestive heart failure, or active tuberculosis) are excluded.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient adherence
Tidsram: 12 months
|
self-report, Morisky measure
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Reduction in systolic blood pressure
Tidsram: 12 months
|
change in systolic blood pressure from baseline to 12 months of follow-up
|
12 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Lisa A Cooper, MD, MPH, Johns Hopkins University
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
- 232
- R01HL069403 (U.S.S. NIH-anslag/kontrakt)
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