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| ID | Type | Description | Link |
|---|---|---|---|
| N01HC25196 | U.S. NIH Grant/Contract | View source |
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The long-term objective is to determine whether better adherence to prescribed medications can be achieved through positive affect induction and self-affirmation leading to reduction in hypertension-related outcomes such as end-stage renal disease, stroke, and cardiovascular mortality among African American patients with poorly controlled hypertension.
The objective of this randomized trial is to evaluate, among African American patients with poorly controlled hypertension, whether a novel intervention of positive affect induction and self-affirmation is more effective than usual care in increasing adherence to prescribed antihypertensive medications. The main outcome will be the change in medication adherence rate from enrollment to 12 months, which is defined as percentage (%) of prescribed doses taken by the patient during the interval of observation as measured by electronic medication event monitoring system (MEMS).
2. Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | 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. | |
| Intervention Group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Within patient change in medication adherence as measured by the MEMS cap. | Every two months for one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Boutin-Foster, MD,MS | Weill Medical College of Cornell University | Principal Investigator |
| Gbenga Ogedegbe, MD, MS | Columbia University | Principal Investigator |
| Mary E Charlson, MD | Weill Medical College of Cornell University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New York Presbyterian Hospital-Weill Medical Center | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19375264 | Background | Boutin-Foster C, Ravenell JE, Greenfield VW, Medmim B, Ogedegbe G. Applying qualitative methods in developing a culturally tailored workbook for black patients with hypertension. Patient Educ Couns. 2009 Oct;77(1):144-7. doi: 10.1016/j.pec.2009.03.008. Epub 2009 Apr 16. | |
| 17274206 | Background | Boutin-Foster C, Ogedegbe G, Ravenell JE, Robbins L, Charlson ME. Ascribing meaning to hypertension: a qualitative study among African Americans with uncontrolled hypertension. Ethn Dis. 2007 Winter;17(1):29-34. |
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No Plan to Share IPD
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| 22269592 | Result | Ogedegbe GO, Boutin-Foster C, Wells MT, Allegrante JP, Isen AM, Jobe JB, Charlson ME. A randomized controlled trial of positive-affect intervention and medication adherence in hypertensive African Americans. Arch Intern Med. 2012 Feb 27;172(4):322-6. doi: 10.1001/archinternmed.2011.1307. Epub 2012 Jan 23. |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |