Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings
Background: Type 1 diabetes (T1D) management is demanding and can impact quality of life among persons with diabetes (PWDs) and their family members. Behavioral intervention research has largely focused on adolescents, and previous interventions that have benefitted quality of life have limited pote...
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| Language: | English |
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Elsevier
2025-06-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000651 |
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| author | Marisa E. Hilliard Wendy Levy Ruth S. Weinstock Korey K. Hood Paula M. Trief Daniel J. DeSalvo Yuliana Rojas Kyrah Holland Aika K. Schneider-Utaka Selma A. Alamarie Lynn Agostini Se-Kang Kim Maartje de Wit Meghan E. McGrady Laurel H. Messer Barbara J. Anderson |
| author_facet | Marisa E. Hilliard Wendy Levy Ruth S. Weinstock Korey K. Hood Paula M. Trief Daniel J. DeSalvo Yuliana Rojas Kyrah Holland Aika K. Schneider-Utaka Selma A. Alamarie Lynn Agostini Se-Kang Kim Maartje de Wit Meghan E. McGrady Laurel H. Messer Barbara J. Anderson |
| author_sort | Marisa E. Hilliard |
| collection | DOAJ |
| description | Background: Type 1 diabetes (T1D) management is demanding and can impact quality of life among persons with diabetes (PWDs) and their family members. Behavioral intervention research has largely focused on adolescents, and previous interventions that have benefitted quality of life have limited potential for implementation in routine care. This trial is piloting a brief behavioral intervention that targets health-related quality of life (HRQOL), which can be implemented with PWDs of all ages in a range of clinical care settings. The aims are to (1) evaluate intervention feasibility and acceptability, (2) explore pre-post change in psychosocial and clinical outcomes, and (3) explore costs related to intervention development and implementation. Methods: Participants are PWD of all ages who receive T1D care in pediatric subspecialty, adult specialty, and primary care settings (target n = 120, 40/site) and a parent (for children) or partner (for adults). Certified diabetes care and education specialists deliver the intervention during two ∼30-45-min remote sessions over 6 months. In the sessions, interventionists review a “quality of life profile” generated from participants’ pre-session responses to a measure of T1D-specific HRQOL, and provide behavioral strategies and resources tailored to their individual strengths and challenges. Feasibility and acceptability data include recruitment/enrollment/retention rates, intervention fidelity, satisfaction surveys, and qualitative interviews. Pre-post measures of psychosocial and clinical outcomes are collected at baseline and 6 months. Conclusion: This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members, designed for implementation across a range of care settings. |
| format | Article |
| id | doaj-art-e107d6b0f8ae4a2ca2866c41bcea7717 |
| institution | OA Journals |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-e107d6b0f8ae4a2ca2866c41bcea77172025-08-20T02:05:10ZengElsevierContemporary Clinical Trials Communications2451-86542025-06-014510149110.1016/j.conctc.2025.101491Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settingsMarisa E. Hilliard0Wendy Levy1Ruth S. Weinstock2Korey K. Hood3Paula M. Trief4Daniel J. DeSalvo5Yuliana Rojas6Kyrah Holland7Aika K. Schneider-Utaka8Selma A. Alamarie9Lynn Agostini10Se-Kang Kim11Maartje de Wit12Meghan E. McGrady13Laurel H. Messer14Barbara J. Anderson15Baylor College of Medicine, Department of Pediatrics, USA; Texas Children's Hospital, USA; Corresponding author. 1102 Bates Avenue, Suite 940, Houston, TX, 77030, USA.Baylor College of Medicine, Department of Pediatrics, USA; Texas Children's Hospital, USASUNY Upstate Medical University, Department of Medicine, USAStanford University School of Medicine, Division of Pediatric Endocrinology and Diabetes, Stanford Diabetes Research Center, USASUNY Upstate Medical University, Department of Psychiatry and Behavioral Sciences, USABaylor College of Medicine, Department of Pediatrics, USA; Texas Children's Hospital, USABaylor College of Medicine, Department of Pediatrics, USA; Texas Children's Hospital, USABaylor College of Medicine, Department of Pediatrics, USA; Texas Children's Hospital, USAStanford University School of Medicine, Division of Pediatric Endocrinology and Diabetes, Stanford Diabetes Research Center, USAStanford University School of Medicine, Division of Pediatric Endocrinology and Diabetes, Stanford Diabetes Research Center, USASUNY Upstate Medical University, Department of Medicine, USABaylor College of Medicine, Department of Pediatrics, USA; Texas Children's Hospital, USAAmsterdam UMC, Location VUMC Amsterdam, the NetherlandsCincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, USA; University of Cincinnati College of Medicine, Department of Pediatrics, USABarbara Davis Center for Diabetes, University of Colorado School of Medicine, Department of Pediatrics, USA; Tandem Diabetes, Inc, USABaylor College of Medicine, Department of Pediatrics, USABackground: Type 1 diabetes (T1D) management is demanding and can impact quality of life among persons with diabetes (PWDs) and their family members. Behavioral intervention research has largely focused on adolescents, and previous interventions that have benefitted quality of life have limited potential for implementation in routine care. This trial is piloting a brief behavioral intervention that targets health-related quality of life (HRQOL), which can be implemented with PWDs of all ages in a range of clinical care settings. The aims are to (1) evaluate intervention feasibility and acceptability, (2) explore pre-post change in psychosocial and clinical outcomes, and (3) explore costs related to intervention development and implementation. Methods: Participants are PWD of all ages who receive T1D care in pediatric subspecialty, adult specialty, and primary care settings (target n = 120, 40/site) and a parent (for children) or partner (for adults). Certified diabetes care and education specialists deliver the intervention during two ∼30-45-min remote sessions over 6 months. In the sessions, interventionists review a “quality of life profile” generated from participants’ pre-session responses to a measure of T1D-specific HRQOL, and provide behavioral strategies and resources tailored to their individual strengths and challenges. Feasibility and acceptability data include recruitment/enrollment/retention rates, intervention fidelity, satisfaction surveys, and qualitative interviews. Pre-post measures of psychosocial and clinical outcomes are collected at baseline and 6 months. Conclusion: This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members, designed for implementation across a range of care settings.http://www.sciencedirect.com/science/article/pii/S2451865425000651Type 1 diabetesPilot studyBehavioral interventionTelehealthQuality of life |
| spellingShingle | Marisa E. Hilliard Wendy Levy Ruth S. Weinstock Korey K. Hood Paula M. Trief Daniel J. DeSalvo Yuliana Rojas Kyrah Holland Aika K. Schneider-Utaka Selma A. Alamarie Lynn Agostini Se-Kang Kim Maartje de Wit Meghan E. McGrady Laurel H. Messer Barbara J. Anderson Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings Contemporary Clinical Trials Communications Type 1 diabetes Pilot study Behavioral intervention Telehealth Quality of life |
| title | Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings |
| title_full | Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings |
| title_fullStr | Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings |
| title_full_unstemmed | Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings |
| title_short | Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings |
| title_sort | design of the type 1 diabetes and life t1dal pilot and feasibility study a brief telehealth intervention targeting health related quality of life across clinical settings |
| topic | Type 1 diabetes Pilot study Behavioral intervention Telehealth Quality of life |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000651 |
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