Study protocol of a randomized controlled trial evaluating the Prime Time Sister Circles (PTSC) program's impact on hypertension among midlife African American women

Chidinma A Ibe, Danielle R Haywood, Ciana Creighton, Yidan Cao, Angel Gabriel, Hossein Zare, Wehmah Jones, Manshu Yang, Michele Balamani, Marilyn Gaston, Gayle Porter, Denise L Woods, Darrell J Gaskin, Chidinma A Ibe, Danielle R Haywood, Ciana Creighton, Yidan Cao, Angel Gabriel, Hossein Zare, Wehmah Jones, Manshu Yang, Michele Balamani, Marilyn Gaston, Gayle Porter, Denise L Woods, Darrell J Gaskin

Abstract

Background: The Prime-Time Sister Circles® (PTSC) program is a multifaceted, community-based peer support intervention targeting African American women who are 40 to 75 years of age. It aims to reduce hypertension disparities observed among African American women by promoting adherence to antihypertensive therapies, including lifestyle modification and therapeutic regimens.

Methods: The PTSC randomized controlled trial will evaluate the effectiveness of the PTSC Program on improved blood pressure control, healthcare utilization attributed to cardiovascular events, and healthcare costs. The study began in 2016 and will end in 2022. African American women who are 40-75 years old, have been diagnosed with hypertension, reside in Washington, D.C. or Baltimore, Maryland, and receive their care from Unity Health Care, a federally qualified health center in Washington, D.C., or Baltimore Medical System, a federally qualified health center in Baltimore, Maryland, are eligible to participate. Those randomized to the intervention group participate in the PTSC Program, which spans 13 weeks and comprises facilitator-led discussions, didactic training about hypertension management, and peer-based problem-solving concerning CVD risk factors and their amelioration. Blood pressure, weight, body mass index, waist circumference, self-reported adherence, physical activity, dietary practices, stress, and healthcare utilization data are collected at baseline, 13 weeks (end of the intervention), 9 months (months post-intervention), and 15 months (one year after the intervention). Healthcare costs will be computed at the end of the study. The study's design is reported in the present manuscript, wherein we employed the SPIRIT checklist to guide its construction.

Discussion: Disparities in hypertension prevalence and management observed among mid-life African American women exist as a result of a confluence of structural determinants of health. Consequently, there is a need to develop, implement, and evaluate culturally appropriate and relevant interventions that are tailored to their lived experiences. The PTSC Trial aims to assess the impact of the program on participants' cardiovascular, psychosocial, and cost outcomes. Its results have implications for advancing the science of designing and implementing culturally relevant interventions for African American women.

Trial registration: Unique identifier: NCT04371614 . Retrospectively registered on April 30, 2020.

Keywords: African American women; Hypertension; Peer support; Stress management.

Conflict of interest statement

No financial competing interests are reported by CAI, DRG, CC, YC, AG, HZ, WJ, MY, and DJG. MB receives consulting fees from the Gaston and Porter Health Improvement Center, Inc., which administers the Prime Time Sister Circle Program and is the intervention that serves as the focus of this paper. MG and GP are the Co-Directors of the Gaston and Porter Health Improvement Center, Inc. DLW is an employee of the Gaston and Porter Health Improvement Center, Inc.

Figures

Fig. 1
Fig. 1
CONSORT Flow Diagram [1]
Fig. 2
Fig. 2
SPIRIT Flow Diagram of the PTSC-RCT Protocol
Fig. 3
Fig. 3
Logic Model for PTSC-RCT

References

    1. Fryar CD, Ostchega Y, Hales CM, Zhang G, Kruszon-Moran D. Hypertension prevalence and control among adults: United States, 2015-2016. NCHS Data Brief. 2017;289:1–8.
    1. Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure: The JNC 7 report. JAMA. 2003;289(19):2560–2572. doi: 10.1001/jama.289.19.2560 [doi].
    1. Danaei G, Ding EL, Mozaffarian D, et al. The preventable causes of death in the united states: Comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009;6(4):e1000058. doi: 10.1371/journal.pmed.1000058 [doi].
    1. Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA. 2010;303(20):2043–2050. doi: 10.1001/jama.2010.650.
    1. Chen V, Ning H, Allen N, et al. Lifetime risks for hypertension by contemporary guidelines in African American and White men and women. JAMA Cardiol. 2019;4(5):455–459. doi: 10.1001/jamacardio.2019.0529.
    1. Go AS, Mozaffarian D, Roger VL, et al. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129(3):399–410. doi: 10.1161/01.cir.0000442015.53336.12.
    1. Hill MN, Bone LR, Kim MT, Miller DJ, Dennison CR, Levine DM. Barriers to hypertension care and control in young urban black men. Am J Hypertens. 1999;12(10 Pt 1):951–958. doi: 10.1016/s0895-7061(99)00121-1.
    1. Rodriguez F, Christopher L, Johnson CE, Wang Y, Foody JM. Love your heart: a pilot community-based intervention to improve the cardiovascular health of African American women. Ethn Dis. 2012;22(4):416–421.
    1. Schoenthaler AM, Lancaster KJ, Chaplin W, Butler M, Forsyth J, Ogedegbe G. Cluster randomized clinical trial of FAITH (FAITH-based approaches in the treatment of hypertension) in blacks. Circ Cardiovasc Qual Outcomes. 2018;11(10):e004691. doi: 10.1161/CIRCOUTCOMES.118.004691.
    1. White BM, Rochell JK, Warren JR. Promoting cardiovascular health for African American women: an integrative review of interventions. J Women's Health (Larchmt) 2020;29(7):952–970. doi: 10.1089/jwh.2018.7580.
    1. Schneider RH, Staggers F, Alxander CN, et al. A randomised controlled trial of stress reduction for hypertension in older African Americans. Hypertension. 1995;26(5):820–827. doi: 10.1161/01.hyp.26.5.820.
    1. Feathers JT, Kieffer EC, Palmisano G, et al. The development, implementation, and process evaluation of the REACH Detroit Partnership's diabetes lifestyle intervention. Diabetes Educ. 2007;33(3):509–520. doi: 10.1177/0145721707301371.
    1. Flack JM, Sica DA, Bakris G, et al. Management of high blood pressure in blacks: an update of the international society on hypertension in blacks consensus statement. Hypertension. 2010;56(5):780–800. doi: 10.1161/HYPERTENSIONAHA.110.152892.
    1. Shaya FT, Gu A, Saunders E. Addressing cardiovascular disparities through community interventions. Ethn Dis. 2006;16(1):138–144.
    1. Gaston MH, Porter GK, Thomas VG. Prime time sister circles: evaluating a gender-specific, culturally relevant health intervention to decrease major risk factors in mid-life African-American women. J Natl Med Assoc. 2007;99(4):428–438.
    1. Thomas VG, Gaston MH, Porter GK, Anderson A. Prime time sister circles(®)II: evaluating a culturally relevant intervention to decrease psychological and physical risk factors for chronic disease in mid-life African American women. J Natl Med Assoc. 2016;108(1):6–18. doi: 10.1016/j.jnma.2015.12.001.
    1. Narayan MC. The national standards for culturally and linguistically appropriate services in health care. Care Manag J. 2001;3(2):77–83. doi: 10.1891/1521-0987.3.2.77.
    1. IQ Solutions, Inc. National Standards for Culturally and Linguistically Appropriate Services in Health Care. U.S. Department of Health and Human Services Office of Minority Health (March 2001). . .
    1. Bandura A. Social foundations of thought and action. Englewood Cliffs, NJ. 1986;1986:23–28.
    1. Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12(1):38–48. doi: 10.4278/0890-1171-12.1.38.
    1. Airhihenbuwa CO. Health promotion and disease prevention strategies for African Americans: a conceptual model. Health issues in the Black community. 1992;1:267–280.
    1. Webb MS, Gonzalez LO. The burden of hypertension: mental representations of African American women. Issues Ment Health Nurs. 2006;27(3):249–271. doi: 10.1080/01612840500502742.
    1. Drayton-Brooks S, White N. Health promoting behaviors among African American women with faith-based support. ABNF J. 2004;15(5):84–90.
    1. Geller JL, Salzer MS. Support groups: current perspectives on theory and practice. Psychiatr Serv. 1997;48(9):1211. doi: 10.1176/ps.48.9.1211.
    1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the american college of cardiology/american heart association task force on clinical practice guidelines. J Am Coll Cardiol. 2018;71(19):e127–e248. doi: 10.1016/j.jacc.2017.11.006.
    1. Gaston MH, Porter GK. Prime time: the African American woman's complete guide to midlife health and wellness. One World/Ballantine; 2003.
    1. Ogedegbe G, Tobin JN, Fernandez S, et al. Counseling African Americans to control hypertension (CAATCH) trial: a multi-level intervention to improve blood pressure control in hypertensive blacks. Circ Cardiovasc Qual Outcomes. 2009;2(3):249–256. doi: 10.1161/CIRCOUTCOMES.109.849976.
    1. Carter-Edwards L, Jackson SA, Runaldue MJ, Svetkey LP. Diet- and blood pressure-related knowledge, attitudes, and hypertension prevalence among African Americans: the KDBP study. Knowledge of diet and blood pressure. Ethn Dis. 2002;12(1):S1–82.
    1. Wallston KA, Stein MJ, Smith CA. Form C of the MHLC scales: a condition-specific measure of locus of control. J Pers Assess. 1994;63(3):534–553. doi: 10.1207/s15327752jpa6303_10.
    1. 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;15(3):90–96. doi: 10.1111/j.1751-7117.2000.tb00211.x.
    1. Song Y, Han HR, Song HJ, Nam S, Nguyen T, Kim MT. Psychometric evaluation of hill-bone medication adherence subscale. Asian Nurs Res (Korean Soc Nurs Sci) 2011;5(3):183–188. doi: 10.1016/j.anr.2011.09.007.
    1. Ard JD, Carson TL, Shikany JM, et al. Weight loss and improved metabolic outcomes amongst rural African American women in the deep south: six-month outcomes from a community-based randomized trial. J Intern Med. 2017;282(1):102–113. doi: 10.1111/joim.12622.
    1. Blanks SH, Treadwell H, Bazzell A, et al. Community engaged lifestyle modification research: engaging diabetic and Prediabetic African American women in community-based interventions. J Obes. 2016;2016:3609289. doi: 10.1155/2016/3609289.
    1. Kang AW, Dulin A, Nadimpalli S, Risica PM. Stress, adherence, and blood pressure control: A baseline examination of black women with hypertension participating in the SisterTalk II intervention. Prev Med Rep. 2018;12:25–32. doi: 10.1016/j.pmedr.2018.08.002 [doi].
    1. Villablanca AC, Warford C, Wheeler K. Inflammation and Cardiometabolic risk in African American women is reduced by a pilot community-based educational intervention. J Women's Health (Larchmt) 2016;25(2):188–199. doi: 10.1089/jwh.2014.5109.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit