scholarly journals Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy (Preprint)

2020 ◽  
Author(s):  
April Idalski Carcone ◽  
Deborah A Ellis ◽  
Susan Eggly ◽  
Karen E MacDonell ◽  
Samiran Ghosh ◽  
...  

BACKGROUND Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults’ innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. OBJECTIVE This research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA<sub>1c</sub>≥9.0%). METHODS A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA<sub>1c</sub>. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome. RESULTS A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023. CONCLUSIONS At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D. CLINICALTRIAL ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20191

10.2196/20191 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e20191
Author(s):  
April Idalski Carcone ◽  
Deborah A Ellis ◽  
Susan Eggly ◽  
Karen E MacDonell ◽  
Samiran Ghosh ◽  
...  

Background Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults’ innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. Objective This research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%). Methods A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome. Results A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023. Conclusions At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D. Trial Registration ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959 International Registered Report Identifier (IRRID) DERR1-10.2196/20191


2020 ◽  
Vol 8 (1) ◽  
pp. e001125
Author(s):  
Cheryl Pritlove ◽  
Benjamin Markowitz ◽  
Geetha Mukerji ◽  
Andrew Advani ◽  
Janet A Parsons

IntroductionWhereas it is widely recognized that emerging adulthood can be a difficult time in the life of an individual living with type 1 diabetes, relatively little is known about the experiences of their parents or guardians. These individuals once shouldered much of the burden for their child’s diabetes ‘self’-management, yet their contribution is often overlooked by the adult healthcare system. Here, we set out to gain an understanding of the perspectives of parents of emerging adults living with type 1 diabetes.Research design and methodsSemi-structured interviews were performed with a purposeful sample of parents of emerging adults with type 1 diabetes recruited from two urban young adult diabetes clinics and through a national diabetes charity. Thematic coding was derived using a constant comparative approach.ResultsAnalysis of interviews with 16 parents of emerging adults with type 1 diabetes identified three themes: parental experiences of the transition to adult care; negotiating parent–child roles, responsibilities and relationships; and new and evolving fears. Parents spoke in detail about the time surrounding their child’s diagnosis of type 1 diabetes to emphasize the complexity of diabetes care and the need to establish a ‘new normal’ for the family. In turn, adolescence and emerging adulthood required a renegotiation of roles and responsibilities, with many parents continuing to play a role in high-level diabetes management. Several parents of emerging adults with type 1 diabetes (particularly those of young men) vocalized worries about their child’s readiness to assume responsibility for their self-care, and some expressed frustration with the apparent dichotomy in the role expectations of parents between the pediatric and adult care settings.ConclusionsAdult healthcare providers should recognize both the ongoing involvement of parents in the ‘self’-management of emerging adults with type 1 diabetes and the unique aspects of the caregiver burden that they experience.


2020 ◽  
Author(s):  
Yuexia Gao ◽  
Yarong Han ◽  
Xin Zou ◽  
Judy Xu ◽  
Dean Getrude Mawen ◽  
...  

Abstract Background: Diabetes distress has been distinguished from depressive symptoms in the linkages to type 2 diabetes management and glycemic control. There are few evidences in rural China untangled the underlying pathways among them. The aim of our study was to examine whether self-efficacy reduced the detrimental effects of psychological variables on diabetes outcomes such as self-care behaviors, glycemic control and health-related quality of life (HRQoL).Methods: 1574 adults diagnosed with type 2 diabetes from 31 rural clinics in China were assessed for psychological variables, self-management and HRQoL. Hemoglobin A1c (HbA1c) data at 6 months after the survey were extracted from electronic medical records. Hierarchical regression model examined independent effects of psychological variables, self-efficacy on diabetes outcomes. KHB method and bootstrapping confidence intervals were employed to test the mediating effect of self-efficacy.Results: Hierarchical regression analysis showed both diabetes distress and depressive symptoms were significantly related to diet and HRQoL, but not related to glycemic control and medication adherence. Depressive symptoms, but not diabetes distress, was directly associated with physical activity. Mediation analysis demonstrated self-efficacy mediated the relationships of both diabetes distress and depressive symptoms on self-care behaviors, glycemic control and HRQoL.Conclusions: Self-efficacy may contribute to better diabetes outcome by ameliorating the effects of diabetes distress and depressive symptoms. Patients with psychological conditions may need tailored intervention that enhance self-efficacy to improve diabetes management.


2012 ◽  
Vol 38 (3) ◽  
pp. 247-254 ◽  
Author(s):  
N. W. Stupiansky ◽  
K. M. Hanna ◽  
J. E. Slaven ◽  
M. T. Weaver ◽  
J. D. Fortenberry

2020 ◽  
Author(s):  
Janine FJ Meijerink ◽  
Marieke Pronk ◽  
Birgit I Lissenberg-Witte ◽  
Vera Jansen ◽  
Sophia E Kramer

BACKGROUND Hearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives. OBJECTIVE The goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older. METHODS Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]). RESULTS Linear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; <i>P</i>=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; <i>P</i>=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; <i>P</i>=.03), which was not sustained at 12 months. CONCLUSIONS This study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain. CLINICALTRIAL ISRCTN77340339; http://www.isrctn.com/ISRCTN77340339 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2016-015012


2020 ◽  
Author(s):  
Yuexia Gao ◽  
Yarong Han ◽  
Xin Zou ◽  
Judy Xu ◽  
Dean Getrude Mawen ◽  
...  

Abstract BackgroundDiabetes distress has been distinguished from depressive symptoms in the linkages to type 2 diabetes management and glycemic control. There are few evidences in rural China untangled the underlying pathways among them. The aim of our study was to examine whether self-efficacy reduced the detrimental effects of psychological variables on diabetes outcomes such as self-care behaviors, glycemic control and health-related quality of life (HRQoL).Methods1574 adults diagnosed with type 2 diabetes from 31 rural clinics in China were assessed for psychological variables, self-management and HRQoL. Hemoglobin A1c (HbA1c) data at 6 months after the survey were extracted from electronic medical records. Hierarchical regression model examined independent effects of psychological variables, self-efficacy on diabetes outcomes. KHB method and bootstrapping confidence intervals were employed to test the mediating effect of self-efficacy.ResultsHierarchical regression analysis showed both diabetes distress and depressive symptoms were significantly related to diet and HRQoL, but not related to glycemic control and medication adherence. Depressive symptoms, but not diabetes distress, was directly associated with physical activity. Mediation analysis demonstrated self-efficacy mediated the relationships of both diabetes distress and depressive symptoms on self-care behaviors, glycemic control and HRQoL.ConclusionsSelf-efficacy may contribute to better diabetes outcome by ameliorating the effects of diabetes distress and depressive symptoms. Patients with psychological conditions may need tailored intervention that enhance self-efficacy to improve diabetes management.


2019 ◽  
Author(s):  
Sarabeth Broder-Fingert ◽  
Jocelyn Lara Kuhn ◽  
Radley Christopher Sheldrick ◽  
Andrea Chu ◽  
Lisa Fortuna ◽  
...  

Abstract Background Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions - and furthermore understanding the impact of each strategy on effectiveness - has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST) – a novel framework developed to optimize interventions - to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation. Methods/Design The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The preparation phase for this study occurred previously. The current study consists of the optimization and evaluation phases. Children ages three-to-twelve years-old who are detected as “at-risk” for behavioral health disorders (n=304) at a large, urban federally qualified community health center will be referred to a Family Partner – a bi-cultural, bi-lingual member of the community with training in behavioral health and systems navigation – who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2x2x2x2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost. Discussion In this protocol paper, we describe how the MOST Framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation.


Healthcare ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1736
Author(s):  
Pao-Yu Lin ◽  
Tzu-Ying Lee ◽  
Chieh-Yu Liu ◽  
Yann-Jinn Lee

To understand the relationship among glycemic control, self-efficacy in diabetes management, and diabetes distress in young people with type 2 diabetes, a cross-sectional descriptive study with convenience sampling was designed. A total of 60 young people who had type 2 diabetes (T2D), with 24 (40%) males and 36 (60%) females were included. The mean age was 17.2 and ranged from 10.5 to 24.5 years, and they completed a Perceived Diabetes Self-Management Scale, the Problem Areas in Diabetes Scale and their pharmacologic management and life adjustment. Glycated hemoglobin (HbA1c) was routinely drawn before the outpatient visit. HbA1c and diabetic distress were positively correlated. Self-efficacy was negatively correlated with HbA1c and diabetic distress. In the hierarchical multiple regression analysis, only the duration of illness and self-efficacy remained significant in the final model. The variance for the overall model was 64%, with self-efficacy alone explaining 30% of the variance. In addition, 31.6% of participants had extremely high levels of psychological distress. Conclusions: T2D is an early onset chronic disease, and the young people may have had other health problems, which made the diabetes management a complex process. Nursing staff should regularly assess both the confidence and ability to manage treatment regimen of young people with type 2 diabetes and their psychological distress.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Sarabeth Broder-Fingert ◽  
Jocelyn Kuhn ◽  
Radley Christopher Sheldrick ◽  
Andrea Chu ◽  
Lisa Fortuna ◽  
...  

Abstract Background Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions—and furthermore understanding the impact of each strategy on effectiveness—has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation. Methods/design The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as “at-risk” for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner—a bicultural, bilingual member of the community with training in behavioral health and systems navigation—who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost. Discussion In this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation. Trial registration ClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.


2019 ◽  
Vol 42 (6) ◽  
pp. 446-453
Author(s):  
Kathleen M. Hanna ◽  
Jed R. Hansen

To provide insight into poorly understood diabetes self-management among emerging adults with type 1 diabetes (TID) experiencing transitions, this study described their diabetes self-management-related habits, routines, and disruptions as well as explored relationships among habits and routines. A qualitative study, guided by critical incidence technique, was conducted. Participants were asked to describe situations when they did and did not check blood glucose, administer insulin, eat meals, and exercise as planned. They were also asked to describe activities in a typical day and in association with diabetes self-management. Content analysis with a priori definitions of habits and routines was performed. Participants described diabetes self-management-related transitional disruption as forgetting and disorder. They described habits associated with checking a blood glucose, giving an insulin dose, eating a meal, and initiating exercise. They described routines in association with meals, exercise, and overall diabetes management. These findings provide information on variables to target in intervention research.


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