Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults

ObjectiveHispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics.Methods and analysisThe Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial to be performed as a community-based participatory research study performed in a Primary Care Setting in Northern Manhattan (New York City). 360 Hispanic adults with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >8%), aged 35–70 years, will be randomised at a 1:1 ratio, within Primary Care Provider clusters. The two study arms are (1) a 12-month CHW intervention and (2) enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls). The end points, assessed after 12 months, are primary = haemoglobin A1c and secondary = blood pressure and low-density lipoprotein-cholesterol levels. In addition, the study will describe the CHW intervention in terms of components and intensity and will assess its effects on (1) medication adherence, (2) medication intensification, (3) diet and (4) physical activity.Ethics and disseminationAll participants will provide informed consent; the study protocol has been approved by the Institutional Review Board of Columbia University Medical Center. CHW interventions hold great promise in improving the well-being of minority populations who suffer from diabetes mellitus. The NOCHOP study will provide valuable information about the efficacy of those interventions vis-à-vis clinically relevant end points and will inform policy makers through a detailed characterisation of the programme and its effects.Clinical trial registration numberNCT00787475 at clinicaltrials.gov

Item and Scale Differential Functioning of the Mini-Mental State Exam Assessed Using the Differential Item and Test Functioning (DFIT) Framework

To illustrate the application of the Differential Item and Test Functioning (DFIT) method using English and Spanish versions of the Mini-Mental State Examination (MMSE)

Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial

Background: Racial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management. Methods/Design: This 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC + NP) or UHC complemented by an NP plus health coach (UHC + NP + HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients’/caregivers’ ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient’s reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP + HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment. Discussion: This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes. Trial registration: ClinicalTrials.gov NCT01918891; Registered 5 August 2013

Mild Cognitive Dysfunction Does Not Affect Diabetes Mellitus Control in Minority Elderly Adults

To determine whether older adults with type 2 diabetes mellitus and cognitive dysfunction have poorer metabolic control of glycosylated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol than those without cognitive dysfunction

Plasma Amyloid and in vivo Brain Amyloid in Late Middle-Aged Hispanics

BACKGROUND: Determining amyloid positivity is possible with cerebrospinal fluid and brain imaging of amyloid, but these methods are invasive and expensive. OBJECTIVE: To relate plasma amyloid-β (Aβ), measured using Single-molecule array (Simoatrademark) assays, to in vivo brain Aβ, measured using positron emission tomography (PET), examine the accuracy of plasma Aβ to predict brain Aβ positivity, and the relation of APOE ɛ4 with plasma Aβ. METHODS: We performed a cross-sectional analysis in a cohort of 345 late middle-aged Hispanic men and women (age 64 years, 72% women). Our primary plasma variable was Aβ 42/Aβ 40 ratio measured with Simoa. Brain Aβ burden was measured as global SUVR with 18F-Florbetaben PET examined continuously and categorically. RESULTS: Plasma Aβ 42/Aβ 40 ratio was inversely associated with global Aβ SUVR (β= -0.13, 95% Confidence Interval (CI): -0.23, -0.03; p = 0.013) and Aβ positivity (Odds Ratio: 0.59, 95% CI: 0.38, 0.91; p = 0.016), independent of demographics and APOE ɛ4. ROC curves (AUC = 0.73, 95% CI: 0.64, 0.82; p <  0.0001) showed that the optimal threshold for plasma Aβ 42/Aβ 40 ratio in relation to brain Aβ positivity was 0.060 with a sensitivity of 82.4% and specificity of 62.8% . APOE ɛ4 carriers had lower Aβ 42/Aβ 40 ratio and a higher Aβ positivity determined with the Aβ 42/Aβ 40 ratio threshold of 0.060. CONCLUSION: Plasma Aβ 42/Aβ 40 ratio assayed using Simoa is weakly correlated with in vivo brain amyloid and has limited accuracy in screening for amyloid positivity and for studying risk factors of brain amyloid burden when in vivo imaging is not feasible

Depression is not associated with diabetes control in minority elderly

We investigated the longitudinal association of depression, with and without cognitive dysfunction, with hemoglobin A1c (HbA1c), systolic blood pressure (SBP), and low-density lipoprotein (LDL) in a predominantly minority cohort

A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial

Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion. This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice. Trial Registration: Clinicaltrials.gov NCT0107005

Advancing PROMIS’s methodology: results of the Third Patient-Reported Outcomes Measurement Information System (PROMIS ® ) Psychometric Summit

In 2002, the NIH launched the ‘Roadmap for Medical Research’. The Patient-Reported Outcomes Measurement Information System (PROMIS®) is one of the Roadmap’s key aspects. To create the next generation of patient-reported outcome measures, PROMIS utilizes item response theory (IRT) and computerized adaptive testing. In 2009, the NIH funded the second wave of PROMIS studies (PROMIS II). PROMIS II studies continue PROMIS’s agenda, but also include new features, including longitudinal analyses and more sociodemographically diverse samples. PROMIS II also includes increased emphasis on pediatric populations and evaluation of PROMIS item banks for clinical research and population science. These aspects bring new psychometric challenges. To address this, investigators associated with PROMIS gathered at the Third Psychometric Summit in September 2010 to identify, describe and discuss pressing psychometric issues and new developments in the field, as well as make analytic recommendations for PROMIS. The summit addressed five general themes: linking, differential item functioning, dimensionality, IRT models for longitudinal applications and new IRT software. In this article, we review the discussions and presentations that occurred at the Third PROMIS Psychometric Summit