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      Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study

      , OTR, PhD 1 , , , OTR, MS 1 , , OTR, MS 1 , , MPH, MD 1 , , PhD 2 , , MD 3 , , MSW, LCSW 3 , , MD 4 , , MS 5 , , PhD 2 , , PhD 6 , , PhD 4 , , BA 6 , , MPH 3 , , RD 3 , , BA 3 , , PhD 4 , 6 , , MFA, PhD 2 , 3 , 7
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      ecological momentary assessments, type 1 diabetes, patient-centered outcomes research, actigraphy, ambulatory monitoring, continuous glucose monitoring, EMA, diabetes, patient-centered outcome, outcome, monitoring, function, emotion, longitudinal, well-being

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          Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D.


          The aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely.


          The FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits.


          The study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection.


          Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D.

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          • Record: found
          • Abstract: found
          • Article: not found

          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
            • Record: found
            • Abstract: found
            • Article: not found

            A brief measure for assessing generalized anxiety disorder: the GAD-7.

            Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
              • Record: found
              • Abstract: found
              • Article: not found

              The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

              A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                October 2021
                22 October 2021
                22 October 2021
                : 10
                : 10
                : e30901
                [1 ] Chan Division of Occupational Science and Occupational Therapy University of Southern California Los Angeles, CA United States
                [2 ] Dornsife Center for Economic & Social Research University of Southern California Los Angeles, CA United States
                [3 ] Keck School of Medicine University of Southern California Los Angeles, CA United States
                [4 ] Division of Endocrinology Department of Medicine Albert Einstein College of Medicine Bronx, NY United States
                [5 ] Suzanne Dworak-Peck School of Social Work University of Southern California Los Angeles, CA United States
                [6 ] Ferkauf Graduate School of Psychology Yeshiva University Bronx, CA United States
                [7 ] Department of Psychology University of Southern California Los Angeles, CA United States
                Author notes
                Corresponding Author: Elizabeth Ann Pyatak beth.pyatak@ 123456usc.edu
                Author information
                ©Elizabeth Ann Pyatak, Raymond Hernandez, Loree T Pham, Khatira Mehdiyeva, Stefan Schneider, Anne Peters, Valerie Ruelas, Jill Crandall, Pey-Jiuan Lee, Haomiao Jin, Claire J Hoogendoorn, Gladys Crespo-Ramos, Heidy Mendez-Rodriguez, Mark Harmel, Martha Walker, Sara Serafin-Dokhan, Jeffrey S Gonzalez, Donna Spruijt-Metz. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.10.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 16 June 2021
                : 11 July 2021
                : 28 July 2021
                : 15 August 2021

                ecological momentary assessments,type 1 diabetes,patient-centered outcomes research,actigraphy,ambulatory monitoring,continuous glucose monitoring,ema,diabetes,patient-centered outcome,outcome,monitoring,function,emotion,longitudinal,well-being


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