NDLI: An observational study protocol to explore loneliness and systemic inflammation in an older adult population with chronic venous leg ulcers

Content Provider	Springer Nature : BioMed Central
Author	Kelechi, Teresa J. Muise-Helmericks, Robin C. Theeke, Laurie A. Cole, Steven W. Madisetti, Mohan Mueller, Martina Prentice, Margaret A.
Abstract	Background Chronic venous leg ulcers (CVLUs) are the most common type of lower extremity wound. Even when treated with evidenced-based care, 30–50% of CVLUs fail to heal. A specific gap exists about the association between psychosocial stressors, particularly loneliness, and biomarkers of inflammation and immunity. Loneliness is highly prevalent in persons with CVLUs, has damaging effects on health, and contributes to the development of multiple chronic conditions, promotes aberrant inflammation, and diminishes healing. However, the confluence of loneliness, inflammation and the wound healing trajectory has not been elucidated; specifically whether loneliness substantially mediates systemic inflammation and alters healing over time. This study seeks to address whether there is a specific biomarker profile associated with loneliness, CVLUs, and wound healing that is different from non-lonely persons with CVLUs. Methods An observational prospective study will identify, characterize and explore associations among psychosocial stressors, symptoms and biomarkers between 2 CVLU groups, with loneliness+ (n = 28) and without loneliness- (n = 28) during 4 weeks of wound treatment, measured at 3 time points. We will examine psychosocial stressors and symptoms using psychometrically-sound measures include PROMIS® and other questionnaires for loneliness, social isolation, depression, anxiety, stigma, sleep, fatigue, pain, quality of life, cognition, and function. Demographics data including health history, sex, age, wound type and size, wound age, and treatment will be recorded from the electronic health record. We will characterize a biomarker panel of inflammatory genes including chemotaxic and growth factors, vascular damage, and immune regulators that express in response to loneliness to loneliness and CVLUs using well-established RNA sequence and PCR methods for whole blood samples. In an exploratory aim we will explore whether age and sex/psychological stressors and symptoms indicate potential moderation/mediation of the effect of loneliness on the biomarker profile over the study period. Discussion This study will provide insight into the influence of psychosocial stressors, symptoms, and biological mechanisms on wound healing, towards advancing a future healing prediction model and interventions to address these stressors and symptoms experienced by persons with CVLUs.
Related Links	https://bmcgeriatr.biomedcentral.com/counter/pdf/10.1186/s12877-021-02060-w.pdf
Ending Page	11
Page Count	11
Starting Page	1
File Format	HTM / HTML
ISSN	14712318
DOI	10.1186/s12877-021-02060-w
Journal	BMC Geriatrics
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2021-02-10
Access Restriction	Open
Subject Keyword	Geriatrics Gerontology Aging Rehabilitation Loneliness Chronic venous leg ulcers Inflammation Social genomics Geriatrics/Gerontology
Content Type	Text
Resource Type	Article
Subject	Geriatrics and Gerontology
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	4.1/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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