Clinical trial NCT01323322: Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Official title: Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes
Cerebrovascular Disease
Age-Associated Decline
Cardiovascular Disease
Keywords: Socioeconomic Status
Longitudinal Study
Health Disparities
Epidemiology
Diversity
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: University of Maryland, Baltimore
name: Rensselaer Polytechnic Institute
name: Johns Hopkins University
name: Massachusetts General Hospital
name: University of Delaware
name: US Department of Housing and Urban Development
First posted: 2011-03-25
Enrollment: 3720
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The baseline HANDLS sample consists of 3720 community-dwelling African American and white adults aged 30-64. Participants were drawn from 13 neighborhoods (groups of contiguous census tracts) in Baltimore City, sampling representatively across a wide range of socioeconomic and income circumstances.

Brief summary: The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study is an interdisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. HANDLS is unique because it assesses physical parameters as well as evaluating genetic, biologic, demographic, and psychosocial parameters of African American and white participants over a wide range of socioeconomic statuses, longitudinally. HANDLS also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, psychology, genomics, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate an understanding of selected underlying factors of persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline.

HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality and Socioeconomic status with Health Status An Interim Follow-up Study began in June 2006 under a separate protocol. It was designed as a follow-up telephone interview approximately 18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim contact with study participants, and important interim information regarding their health. Now completed, waves 3, 4 and 5 were follow-up examinations visits to our mobile Medical Research Vehicles (MRVs). In September 2020, HANDLS initiated wave 6; telephone interviews and limited in-person visits as a COVID-centric protocol. The current protocol outlines Wave 7, the fourth follow-up examination and the participants fifth visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 7 consists of health examinations, questionnaires, sensory assessments (visual and olfactory), health literacy assessment, renal function assessments, environmental assessments, and for a sub-set of participants; structural MRIs, a personality inventory and an examination of sleep and cognition under separate protocols. HANDLS will resume in-person examinations with wave 7 in which we will prioritize contacting participants who were not seen in wave 5.

Detailed description: The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study is an interdisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. HANDLS is unique because it assesses physical parameters as well as evaluating genetic, biologic, demographic, and psychosocial parameters of African American and white participants over a wide range of socioeconomic statuses, longitudinally. HANDLS also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, psychology, genomics, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate an understanding of selected underlying factors of persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline.

HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality and Socioeconomic status with Health Status An Interim Follow-up Study began in June 2006 under a separate protocol. It was designed as a follow-up telephone interview approximately 18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim contact with study participants, and important interim information regarding their health. Now completed, waves 3, 4 and 5 were follow-up examinations visits to our mobile Medical Research Vehicles (MRVs). In September 2020, HANDLS initiated wave 6; telephone interviews and limited in-person visits as a COVID-centric protocol. The current protocol outlines Wave 7, the fourth follow-up examination and the participants fifth visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 7 consists of health examinations, questionnaires, sensory assessments (visual and olfactory), health literacy assessment, renal function assessments, environmental assessments, and for a sub-set of participants; structural MRIs, a personality inventory and an examination of sleep and cognition under separate protocols. HANDLS will resume in-person examinations with wave 7 in which we will prioritize contacting participants who were not seen in wave 5.

Eligibility criteria: * INCLUSION CRITERIA:
* Verified HANDLS participants (age 30-64 at baseline recruitment)
* Able to give informed consent (or has a legal designee); and
* Must have valid picture identification.

EXCLUSION CRITERIA:

* Pregnancy
* Current cancer chemotherapy or radiation therapy
* Positive COVID test at point of care testing on examination visit date.

Inclusion of vulnerable participants:

Adult Participants who Lack Capacity to Consent: Participants who temporarily or permanently lose the capacity to provide consent after initially enrolling in the HANDLS study may continue to participate in follow up visits if they have an executed DPA for research in their study record or are able to provide a copy of a DPA for research executed outside of the study. Procedures for including participants who are decisionally impaired, including assessing capacity to consent and execution of the DPA will follow guidelines set forth in the NIH policy 3014-403 Research Involving Adults Who Lack Decision-making Capacity to Consent to Research Participation and recommendations in the National Institute of Mental Health Human Subjects Research Protections Toolkit.

It is expected over the course of the study that some participants will experience cognitive decline. It will be important to continue to include all participants in the study for as long as is practical because we are studying lifetime trajectories of health and require an unbiased sample to draw reasonable conclusions. Participants are invited to complete a Durable Power of Attorney (DPA) for Research at each study visit. Prior to each follow-up examination visit, assessment of capacity to consent will be (1) initiated at the time of appointment setting (2) reassessed at the pre-visit screening, and (3) final determination at the time of consent. If at any time during the pre-visit activities a participant s capacity to consent is questioned, the Squires Capacity Assessment will be administered, and the study clinician will make the final assessment about whether to initiate consent by using the Legally Authorized Representative (LAR).

Primary outcomes:
measure: To disentangle the relationship between race, SES, and health outcomes.
timeFrame: 4 to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute of Aging, Clinical Research Unit
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Michele K Evans, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claudel SE, Shiroma EJ, Harris TB, Mode NA, Ahuja C, Zonderman AB, Evans MK, Powell-Wiley TM. Cross-Sectional Associations of Neighborhood Perception, Physical Activity, and Sedentary Time in Community-Dwelling, Socioeconomically Diverse Adults. Front Public Health. 2019 Sep 13;7:256. doi: 10.3389/fpubh.2019.00256. eCollection 2019.