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Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy
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-determin...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609201/ https://www.ncbi.nlm.nih.gov/pubmed/33079068 http://dx.doi.org/10.2196/20191 |
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author | Idalski Carcone, April Ellis, Deborah A Eggly, Susan MacDonell, Karen E Ghosh, Samiran Buggs-Saxton, Colleen Ondersma, Steven J |
author_facet | Idalski Carcone, April Ellis, Deborah A Eggly, Susan MacDonell, Karen E Ghosh, Samiran Buggs-Saxton, Colleen Ondersma, Steven J |
author_sort | Idalski Carcone, April |
collection | PubMed |
description | 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(1c) (HbA(1c)), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA(1c)≥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(1c). 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 |
format | Online Article Text |
id | pubmed-7609201 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-76092012020-11-16 Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy Idalski Carcone, April Ellis, Deborah A Eggly, Susan MacDonell, Karen E Ghosh, Samiran Buggs-Saxton, Colleen Ondersma, Steven J JMIR Res Protoc Protocol 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(1c) (HbA(1c)), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA(1c)≥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(1c). 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 JMIR Publications 2020-10-20 /pmc/articles/PMC7609201/ /pubmed/33079068 http://dx.doi.org/10.2196/20191 Text en ©April Idalski Carcone, Deborah A Ellis, Susan Eggly, Karen E MacDonell, Samiran Ghosh, Colleen Buggs-Saxton, Steven J Ondersma. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.10.2020. https://creativecommons.org/licenses/by/4.0/ 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 http://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Idalski Carcone, April Ellis, Deborah A Eggly, Susan MacDonell, Karen E Ghosh, Samiran Buggs-Saxton, Colleen Ondersma, Steven J Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy |
title | Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy |
title_full | Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy |
title_fullStr | Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy |
title_full_unstemmed | Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy |
title_short | Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy |
title_sort | improving diabetes management in emerging adulthood: an intervention development study using the multiphase optimization strategy |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609201/ https://www.ncbi.nlm.nih.gov/pubmed/33079068 http://dx.doi.org/10.2196/20191 |
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