- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00195182
Psychosocial Determinants of Medication Adherence in Hypertensive African Americans
The specific aims for this study are:
- To examine the relationship between perceived racism and medication adherence among hypertensive African-American patients.
- To determine if psychological stress and depression mediate the relationship between perceived racism and medication adherence.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Achieving and maintaining recommended blood pressure goals in hypertensive African Americans is paramount to addressing racial disparities in hypertension-related morbidity and mortality. Because antihypertensive therapy is the cornerstone of hypertension management, good medication adherence is the key to adequate blood pressure control. Successful approaches to racial disparities must address how to increase adherence to anti-hypertensive medications.
Adherence to anti-hypertensive medications is likely multifactorial, and not solely related to SES or access to medical care. Psychosocial factors such as stress and depression have been implicated as important determinants of medication adherence. However, little is known about how other psychosocial factors such as perceived racism impact anti-hypertensive medication adherence. Understanding these relationships may assist in the development of targeted strategies to achieve good medication adherence in hypertensive patients.
The objective is to understand the relationships between perceived racism and medication adherence, while examining the role of depression, psychological stress, and self-efficacy in a population of hypertensive African-American patients. 262 African American adult hypertensive patients will be recruited from an urban academic general medicine practice. Baseline data collection will include assessments of demographics and socioeconomic status, clinical history and hypertension characteristics, depressive symptoms, perceived stress, and medication adherence. Patients will be followed for 1 year, when final evaluations will take place, including assessment of hypertension, stress, depression, medication adherence and level of perceived racism (measured by a validated instrument). The primary outcome is the change in medication adherence scores from baseline to 12 months. Statistical models will be developed to determine if level of perceived racism is associated with medication adherence, and whether stress and depression play a role in this relationship.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10021
- New York Presbyterian Hospital-Weill Medical College
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients must be self-identified as African American.
- All patients must be aged 18 years or older.
- All patients must be diagnosed as having hypertension (for this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, specifically a systolic blood pressure >140 mm hg or a diastolic blood pressure >90 mm hg) or if patients are taking any prescribed anti-hypertensive medication.
- Patients must be able to provide informed consent in English.
Exclusion Criteria:
- Patients who are unable to walk several blocks for any reason.
- Patients who refused to participate.
- Patients who are unable to provide informed consent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
1. No intervention
This group received follow-up every 2-months for one year.
Follow-up included questions about their blood pressure and how well they had been able to adhere to their medication goal.
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During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group.
The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence.
Patient also received small token gifts to remind them of their participation in the study and to induce positive affect.
The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
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2. Experimental
This group received follow-up every 2-months for one year.
Follow-up included questions about their blood pressure and how well they had been able to engage adhere to their medication goal.
The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level.
|
During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group.
The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence.
Patient also received small token gifts to remind them of their participation in the study and to induce positive affect.
The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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To evaluate intervention of induced positive affect and induced self-affirmation will increase medication adherence among African-American hypertensive patients.
Lasso di tempo: every two months for one year
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every two months for one year
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Joseph E Ravenell, MD, MS, University of Texas Southwestern Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
- Ravenell JE, Charlson ME. Stressed out: Definitions of stress among hypertensive African American men. Journal of General Internal Medicine 20(S1):128, 2005.
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Inizio studio
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0302006001
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