Dataset Information

Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity.

ABSTRACT:

Introduction

Although physical activity (PA) reduces cardiovascular disease (CVD) risk, physical inactivity remains a pressing public health concern, especially among African American (AA) women in the USA. PA interventions focused on AA women living in resource-limited communities with scarce PA infrastructure are needed. Mobile health (mHealth) technology can increase access to PA interventions. We describe the development of a clinical protocol for a multilevel, community-based, mHealth PA intervention for AA women.

Methods and analysis

An mHealth intervention targeting AA women living in resource-limited Washington, DC communities was developed based on the socioecological framework for PA. Over 6?months, we will use a Sequential Multi-Assignment, Randomized Trial approach to compare the effects on PA of location-based remote messaging (named 'tailored-to-place') to standard remote messaging in an mHealth intervention. Participants will be randomised to a remote messaging intervention for 3?months, at which point the intervention strategy will adapt based on individuals' PA levels. Those who do not meet the PA goal will be rerandomised to more intensive treatment. Participants will be followed for another 3?months to determine the contribution of each mHealth intervention to PA level. This protocol will use novel statistical approaches to account for the adaptive strategy. Finally, effects of PA changes on CVD risk biomarkers will be characterised.

Ethics and dissemination

This protocol has been developed in partnership with a Washington, DC-area community advisory board to ensure feasibility and acceptability to community members. The National Institutes of Health Intramural IRB approved this research and the National Heart, Lung, and Blood Institute provided funding. Once published, results of this work will be disseminated to community members through presentations at community advisory board meetings and our quarterly newsletter.

Trial registration number

NCT03288207.

SUBMITTER: Tamura K

PROVIDER: S-EPMC7754642 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity.

Tamura Kosuke K Vijayakumar Nithya P NP Troendle James F JF Curlin Kaveri K Neally Sam J SJ Mitchell Valerie M VM Collins Billy S BS Baumer Yvonne Y Gutierrez-Huerta Cristhian A CA Islam Rafique R Turner Briana S BS Andrews Marcus R MR Ceasar Joniqua N JN Claudel Sophie E SE Tippey Kathryn G KG Giuliano Shayne S McCoy Regina R Zahurak Jessica J Lambert Sharon S Moore Philip J PJ Douglas-Brown Mary M Wallen Gwenyth R GR Dodge Tonya T Powell-Wiley Tiffany M TM

BMJ open 20201221 12

<h4>Introduction</h4>Although physical activity (PA) reduces cardiovascular disease (CVD) risk, physical inactivity remains a pressing public health concern, especially among African American (AA) women in the USA. PA interventions focused on AA women living in resource-limited communities with scarce PA infrastructure are needed. Mobile health (mHealth) technology can increase access to PA interventions. We describe the development of a clinical protocol for a multilevel, community-based, mHeal ...[more]

PMID: 33371027

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Project description:IntroductionClinical guidelines are crucial for assisting health professionals to make correct clinical decisions. However, manual clinical guidelines are not accessible, and this increases the workload. So, a mobile-based clinical guideline application is needed to provide real-time information access. Hence, this study aimed to assess health professionals' intention to accept mobile-based clinical guideline applications and verify the unified theory of acceptance and technology utilization model.MethodsInstitutional-based cross-sectional study design was used among 803 study participants. The sample size was determined based on structural equation model parameter estimation criteria with stratified random sampling. Amos version 23 software was used for analysis. Internal consistency of latent variable items, and convergent and divergent validity, were evaluated using composite reliability, AVE, and a cross-loading matrix. Model fitness of the data was assessed based on a set of criteria, and it was achieved. P-value < 0.05 was considered for assessing the formulated hypothesis.ResultsEffort expectancy and social influence had a significant effect on health professionals' attitudes, with path coefficients of (β = 0.61, P-value < 0.01), and (β = 0.510, P-value < 0.01) respectively. Performance expectancy, facilitating condition, and attitude had significant effects on health professionals' acceptance of mobile-based clinical guideline applications with path coefficients of (β = 0.37, P-value < 0.001), (β = 0.44, P-value < 0.001) and (β = 0.57, P-value < 0.05) respectively. Effort expectancy and social influence were mediated by attitude and had a significant partial relationship with health professionals' acceptance of mobile-based clinical guideline application with standardized estimation coefficients of (β = 0.22, P-value = 0.027), and (β = 0.19, P-value = 0.031) respectively. All the latent variables accounted for 57% of health professionals' attitudes, and latent variables with attitudes accounted for 63% of individuals' acceptance of mobile-based clinical guideline applications.ConclusionsThe unified theory of acceptance and use of the technology model was a good model for assessing individuals' acceptance of mobile-based clinical guidelines applications. So, enhancing health professionals' attitudes, and computer literacy through training are needed. Mobile application development based on user requirements is critical for technology adoption, and people's support is also important for health professionals to accept and use the application.

Project description:The new 2010 World Health Organization (WHO) HIV treatment guidelines recommend earlier antiretroviral therapy (ART) initiation (CD4<350 cells/µl instead of CD4<200 cells/µl), multiple sequential ART regimens, and replacement of first-line stavudine with tenofovir. This paper considers what to do first in resource-limited settings where immediate implementation of all of the WHO recommendations is not feasible.We use a mathematical model and local input data to project clinical and economic outcomes in a South African HIV-infected cohort (mean age?=?32.8 y, mean CD4?=?375/µl). For the reference strategy, we assume that all patients initiate stavudine-based ART with WHO stage III/IV disease and receive one line of ART (stavudine/WHO/one-line). We rank-in survival, cost-effectiveness, and equity terms-all 12 possible combinations of the following: (1) stavudine replacement with tenofovir, (2) ART initiation (by WHO stage, CD4<200 cells/µl, or CD4<350 cells/µl), and (3) one or two regimens, or lines, of available ART. Projected life expectancy for the reference strategy is 99.0 mo. Considering each of the guideline components separately, 5-y survival is maximized with ART initiation at CD4<350 cells/µl (stavudine/<350/µl/one-line, 87% survival) compared with stavudine/WHO/two-lines (66%) and tenofovir/WHO/one-line (66%). The greatest life expectancies are achieved via the following stepwise programmatic additions: stavudine/<350/µl/one-line (124.3 mo), stavudine/<350/µl/two-lines (177.6 mo), and tenofovir/<350/µl/two-lines (193.6 mo). Three program combinations are economically efficient: stavudine/<350/µl/one-line (cost-effectiveness ratio, US$610/years of life saved [YLS]), tenofovir/<350/µl/one-line (US$1,140/YLS), and tenofovir/<350/µl/two-lines (US$2,370/YLS).In settings where immediate implementation of all of the new WHO treatment guidelines is not feasible, ART initiation at CD4<350 cells/µl provides the greatest short- and long-term survival advantage and is highly cost-effective.

Dataset Information

Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity.

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