Translational Research Principles of an Effectiveness Trial for Diabetes Care in an Urban African American Population

Purpose Large-scale effectiveness trials designed to translate evidence-based diabetes care to community settings are few. Studies describing these methods among high-risk minority populations are particularly limited. Methods The authors describe Project Sugar, a randomized controlled trial conducted in 2 phases: Project Sugar 1 (1994-1999), which piloted a 4-arm clinic and homebased intervention using nurse case management and community health workers in 186 urban African Americans with type 2 diabetes, and Project Sugar 2 (2000-2005), which examined effectiveness of this intervention among 542 diabetic, urban African Americans. Results and Conclusions Project Sugar had success with regard to recruitment and retention, both in phase 1 (80% rate at 24 months) and phase 2 (>90% at 24 months). Using the RE-AIM framework, planning and research design for Project Sugar 2 is described in detail for elements that contributed to the reach, effectiveness, adoption, implementation, and maintenance of this study within a minority community setting. In addition to successful strategies, challenges to conducting effectiveness trials in an inner-city African American community are identified.

Download Full-text

Engaging African American Parents to Develop a Mobile Health Technology for Breastfeeding: KULEA-NET

Journal of Human Lactation ◽

10.1177/0890334420930208 ◽

2020 ◽

Vol 36 (3) ◽

pp. 448-460 ◽

Cited By ~ 1

Author(s):

Loral Patchen ◽

Lindsey Ellis ◽

Cherise B. Harrington ◽

Tony Ma ◽

Rohini Mohanraj ◽

...

Keyword(s):

African American ◽

African Americans ◽

Social Desirability ◽

Mobile Health ◽

Phase 1 ◽

Health Technology ◽

African American Parents ◽

System Usability Scale ◽

System Usability ◽

Public Breastfeeding

Background African Americans breastfeed less than other groups, which has implications for health throughout the life course. Little is known about mobile health technologies to support breastfeeding. Research aims This study proceeded in two phases. The aim of Phase 1 was to identify ideal technological components and content of a mobile health intervention. The aim of Phase 2 was to determine the usability of a prototype, KULEA-NET, based on the Phase 1 findings. Methods For this mixed-methods study, we used community-based participatory research methods and user-centered technology design methods. We used open coding in NVivo 11 to organize data from focus groups and in-depth interviews, then we analyzed the data. We then developed a prototype and tested the prototype’s usability with the System Usability Scale. Fifty pregnant and postpartum African Americans from the District of Columbia participated. Results Participants preferred an app with text messaging technology and identified areas for intervention: self-efficacy, parent-child attachment beliefs, social support, public breastfeeding and social desirability, and returning to work. Desired features included local resources, support person access, baby care logs, identification of public breastfeeding venues, and peer discussions. The System Usability Scale score was 73.8, which indicates above average usability. Conclusions A mobile health technology like KULEA-NET can be used to meet the breastfeeding needs of African Americans, build social desirability, and complement traditional health care. The appeal of an African American-specific intervention is unclear. Responding to mixed feeding practices is challenging. KULEA-NET is a mobile breastfeeding intervention guided by the preferences of African American parents and offers promising usability metrics.

Download Full-text

Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN): study protocol for a randomized controlled trial of a unique a la carte intervention approach to self-management of lupus in African Americans

BMC Health Services Research ◽

10.1186/s12913-016-1580-6 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 11

Author(s):

Edith M. Williams ◽

Kate Lorig ◽

Saundra Glover ◽

Diane Kamen ◽

Sudie Back ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

African American ◽

African Americans ◽

Study Protocol ◽

Controlled Trial ◽

Self Management ◽

Improve Quality ◽

Randomized Controlled

Download Full-text

Genome wide-association study identifies novel loci in the Primary Open-Angle African American Glaucoma Genetics (POAAGG) study

10.1101/2020.02.27.968156 ◽

2020 ◽

Cited By ~ 1

Author(s):

Harini V. Gudiseva ◽

Shefali Setia Verma ◽

Venkata R. M. Chavali ◽

Rebecca J. Salowe ◽

Anastasia Lucas ◽

...

Keyword(s):

African American ◽

African Americans ◽

Large Scale ◽

Genome Wide Association Study ◽

Open Angle Glaucoma ◽

Retinal Ganglion ◽

Open Angle ◽

Chromosome 11 ◽

Disease Biology ◽

Genome Wide

AbstractPrimary open-angle glaucoma (POAG), the leading cause of irreversible blindness worldwide, disproportionately affects African Americans. Large-scale POAG genetic studies have focused on individuals of European and Asian ancestry, limiting our understanding of disease biology. Here we report genetic analysis of the largest-ever deeply phenotyped African American population (n=5950), identifying a novel POAG-associated SNP on chromosome 11 near the TRIM66 gene (rs112369934). POAG trait association also implicated SNPs in genes involved in trabecular meshwork homeostasis and retinal ganglion cell maintenance. These new loci deepen our understanding of the pathophysiology of POAG in African Americans.

Download Full-text

Associations between Perceived Racial Discrimination and Tobacco Cessation among Diverse Treatment Seekers

Ethnicity & Disease ◽

10.18865/ed.30.3.411 ◽

2020 ◽

Vol 30 (3) ◽

pp. 411-420

Author(s):

Monica Webb Hooper ◽

Patricia Calixte-Civil ◽

Christina Verzijl ◽

Karen O. Brandon ◽

Taghrid Asfar ◽

...

Keyword(s):

African American ◽

African Americans ◽

Tobacco Cessation ◽

Perceived Discrimination ◽

Controlled Trial ◽

Ethnic Discrimination ◽

Post Intervention ◽

American Black ◽

Prospective Longitudinal ◽

Racial Ethnic

Objectives: This study investigated a) racial/ethnic differences in past-year discrimination experiences and b) associations between discrimination and smoking abstinence.Design: Prospective, longitudinal analysis of smoking status. Perceived past-year discrimination was assessed at baseline. ANCOVAs and intent-to-treat hierarchical logistic regressions were conducted.Setting: Dual-site (Tampa, FL and Miami, FL) randomized controlled trial testing the effects of a group cessation intervention plus pharmacotherapy.Participants: Treatment-seeking adult smokers (N=347; non-Hispanic White, non-Hispanic African American/Black, or Hispanic).Main Outcome Measures: Biochemically verified 7-day point prevalence abstinence (7-day ppa) was assessed immediately post-intervention and at 6-month follow-up.Results: After controlling for covariates, African Americans/Blacks reported greater perceived discrimination compared with non-Hispanic Whites (P=.02), and Hispanics (P=.06). Non-Hispanic Whites and Hispanics did not differ in perceived racial/ethnic discrimination experiences over the past year. Irrespective of race/ ethnicity, past-year perceived discrimination was inversely associated with 7-day ppa, both post-intervention (AOR=.97, CI: .95-.99) and at 6-months (AOR=.98, CI: .96-.99). Among African Americans/Blacks, past-year perceived discrimination was inversely associated with 7-day ppa, both post-intervention (AOR=.95, CI: .92-.97) and at 6-months (AOR=.97, CI: .94-.99). Perceived discrimination was unrelated to 7-day ppa among Hispanics. Among non-Hispanic Whites, past-year perceived discrimination was inversely associated with post-intervention 7-day ppa (AOR=.95, CI: .91-.99), but not 6-months.Conclusions: Perceived racial/ethnic discrimination was greater among African American/Black smokers compared with non-Hispanic Whites. Perceived discrimination was negatively associated with tobacco cessation in the full sample, and for African Americans at 6-months post-intervention. These data have implications for intervention delivery and health disparities.Ethn Dis. 2020;30(3):411-420; doi:10.18865/ed.30.3.411

Download Full-text

Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression in Primary Care in India: Findings from a Randomized Pilot Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17176368 ◽

2020 ◽

Vol 17 (17) ◽

pp. 6368 ◽

Cited By ~ 1

Author(s):

Shital S. Muke ◽

Deepak Tugnawat ◽

Udita Joshi ◽

Aditya Anand ◽

Azaz Khan ◽

...

Keyword(s):

Primary Care ◽

Large Scale ◽

Training Programs ◽

Health Workers ◽

Psychological Treatment ◽

Controlled Trial ◽

Pilot Trial ◽

Course Content ◽

Face To Face ◽

Digital Training

Introduction: Task sharing holds promise for scaling up depression care in countries such as India, yet requires training large numbers of non-specialist health workers. This pilot trial evaluated the feasibility and acceptability of a digital program for training non-specialist health workers to deliver a brief psychological treatment for depression. Methods: Participants were non-specialist health workers recruited from primary care facilities in Sehore, a rural district in Madhya Pradesh, India. A three-arm randomized controlled trial design was used, comparing digital training alone (DGT) to digital training with remote support (DGT+), and conventional face-to-face training. The primary outcome was the feasibility and acceptability of digital training programs. Preliminary effectiveness was explored as changes in competency outcomes, assessed using a self-reported measure covering the specific knowledge and skills required to deliver the brief psychological treatment for depression. Outcomes were collected at pre-training and post-training. Results: Of 42 non-specialist health workers randomized to the training programs, 36 including 10 (72%) in face-to-face, 12 (86%) in DGT, and 14 (100%) in DGT+ arms started the training. Among these participants, 27 (64%) completed the training, with 8 (57%) in face-to-face, 8 (57%) in DGT, and 11 (79%) in DGT+. The addition of remote telephone support appeared to improve completion rates for DGT+ participants. The competency outcome improved across all groups, with no significant between-group differences. However, face-to-face and DGT+ participants showed greater improvement compared to DGT alone. There were numerous technical challenges with the digital training program such as poor connectivity, smartphone app not loading, and difficulty navigating the course content—issues that were further emphasized in follow-up focus group discussions with participants. Feedback and recommendations collected from participants informed further modifications and refinements to the training programs in preparation for a forthcoming large-scale effectiveness trial. Conclusions: This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.

Download Full-text

The Feasibility of a Strategy for the Remote Recruitment, Consenting and Assessment of Recent Referrals: A Protocol for Phase 1 of the on-line Parent Training for the Initial Management of ADHD Referrals (OPTIMA).

10.21203/rs.3.rs-735069/v1 ◽

2021 ◽

Author(s):

Katarzyna Kostyrka-Allchorne ◽

Claire Ballard ◽

Sarah Byford ◽

Samuele Cortese ◽

David Daley ◽

...

Keyword(s):

Data Collection ◽

Parent Training ◽

Large Scale ◽

Low Cost ◽

Controlled Trial ◽

Phase 1 ◽

Online Data ◽

Parenting Support ◽

Disruptive Behaviours ◽

Randomised Controlled

Abstract Background: In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waiting list. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children’s health services to implement a remote strategy for recruitment, screening, and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here we present the protocol for Phase 1 of OPTIMA – a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). Methods: This is a single arm observational feasibility study. Parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. Discussion: Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely. Trial registration: N/A

Download Full-text

Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial

BMC Health Services Research ◽

10.1186/s12913-015-0695-5 ◽

2015 ◽

Vol 15 (1) ◽

Cited By ~ 26

Author(s):

Robyn A McDermott ◽

Barbara Schmidt ◽

Cilla Preece ◽

Vickie Owens ◽

Sean Taylor ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Community Health Workers ◽

Diabetes Care ◽

Health Workers ◽

Controlled Trial ◽

Indigenous Communities ◽

Randomized Controlled ◽

Cluster Randomized ◽

Improve Diabetes Care

Download Full-text

Feasibility and Acceptability of a Tailored Infant Safe Sleep Coaching Intervention for African American Families

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18084133 ◽

2021 ◽

Vol 18 (8) ◽

pp. 4133

Author(s):

Trina C. Salm Ward ◽

Jane McPherson ◽

Steven M. Kogan

Keyword(s):

African American ◽

Behavioral Interventions ◽

Large Scale ◽

Controlled Trial ◽

Text Message ◽

The United States ◽

African American Families ◽

Safe Sleep ◽

Complex Needs ◽

American Families

Background: Approximately 3600 infants die suddenly and unexpectedly annually in the United States. Research suggests limitations of current behavioral interventions to reduce the risk for sleep-related deaths among African American families living in under-resourced neighborhoods. Guided by the theory of planned behavior and the socio-ecological model, the My Baby’s Sleep (MBS) intervention intends to reduce the risk for sleep-related infant deaths while addressing complex needs of African American families living in under-resourced neighborhoods. Objective: To assess feasibility and acceptability of MBS, a 7-month intervention that includes four home visits and multiple check-ins via phone and text message. Methods: This was a single-arm feasibility and acceptability study with quantitative and qualitive measures. African American families were recruited from community agencies that served an under-resourced metropolitan area. Results: Eight families (eight mothers, nine co-caregivers) completed the intervention. Families reported high acceptability of MBS content, process, and format, as evidenced by qualitative data and mean evaluation scores. Conclusion: MBS is feasible and acceptable among African American families living in under-resourced neighborhoods. These results suggest further investigation of MBS intervention efficacy in a large-scale randomized controlled trial.

Download Full-text

Behavioural activation delivered by the non-specialist: phase II randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.110.079111 ◽

2011 ◽

Vol 198 (1) ◽

pp. 66-72 ◽

Cited By ~ 112

Author(s):

David Ekers ◽

David Richards ◽

Dean McMillan ◽

J. Martin Bland ◽

Simon Gilbody

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Mental Health Professionals ◽

Social Adjustment ◽

Large Scale ◽

Health Workers ◽

Controlled Trial ◽

Behavioural Activation ◽

Cognitive Behaviour ◽

Randomised Controlled

BackgroundBehavioural activation appears as effective as cognitive– behaviour therapy (CBT) in the treatment of depression. If equally effective, then behavioural activation may be the preferred treatment option because it may be suitable for delivery by therapists with less training. This is the first randomised controlled trial to look at this possibility.AimsTo examine whether generic mental health workers can deliver effective behavioural activation as a step-three high-intensity intervention.MethodA randomised controlled trial (ISRCTN27045243) comparing behavioural activation (n = 24) with treatment as usual (n = 23) in primary care.ResultsIntention-to-treat analyses indicated a difference in favour of behavioural activation of –15.79 (95% CI –24.55 to –7.02) on the Beck Depression Inventory–II and Work and Social Adjustment Scale (mean difference –11.12, 95% CI –17.53 to –4.70).ConclusionsEffective behavioural activation appears suitable for delivery by generic mental health professionals without previous experience as therapists. Large-scale trial comparisons with an active comparator (CBT) are needed.

Download Full-text

Development of a Participatory Capacity- Building Program for Congregational Health Leaders in African American Churches in the US South

Ethnicity & Disease ◽

10.18865/ed.28.1.11 ◽

2018 ◽

Vol 28 (1) ◽

pp. 11 ◽

Cited By ~ 3

Author(s):

Mercedes M. Morales-Aleman ◽

Artisha Moore ◽

Isabel C. Scarinci

Keyword(s):

Colorectal Cancer ◽

African American ◽

African Americans ◽

Capacity Building ◽

Culturally Relevant ◽

Health Workers ◽

Lifestyle Changes ◽

Congregational Health ◽

Building Program ◽

Capacity Building Program

African Americans are disproportionately affected by diabetes and colorectal cancer. Although studies have shown the effectiveness of spiritually based health interventions delivered by community health workers to African Americans, few have described the development of the capacity-building component. This article describes this process. The development of the Healthy Congregations Healthy Communities Program (HCHC) was guided through a community-based participatory research lens and included: 1) establishment of a community coalition; 2) identification by coalition members of churches as the best venues for health promotion strategies among African Americans; 3) recruitment of churches; 4) development of a training manual; 5) recruitment and training of congregational health leaders (CHLs); and 6) “Passing of the torch” from the coalition to the CHLs who implemented the intervention in their congregations. We trained 35 CHLs to promote awareness about diabetes and colorectal cancer using a culturally relevant, spiritually based curriculum. Pre- and post-test paired t-tests showed significant increases in CHLs’ knowledge of wellness (P<.001), colorectal cancer (P<.002), nutrition (P<.004), and lifestyle changes (P<.005). The community-academic partnership was successful in developing a culturally relevant, spiritually based capacity-building program for African American CHLs to implement health promotion strategies in their congregations and communities.Ethn Dis.2018;28(1):11-18; doi:10.18865/ed.28.1.11.

Download Full-text