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OBJECTIVE: This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). RESEARCH DESIGN AND METHODS: A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS: All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS: This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.
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Diabetes Mellitus Tipo 2 , Tutoria , Atenção Primária à Saúde , Humanos , Diabetes Mellitus Tipo 2/terapia , Masculino , Feminino , Pessoa de Meia-Idade , Tutoria/métodos , Idoso , Adulto , Hemoglobinas Glicadas/metabolismo , Pessoal Técnico de SaúdeRESUMO
BACKGROUND: Hispanic individuals have higher type 2 diabetes (T2D) prevalence, poorer outcomes, and are disproportionately affected by COVID-19. Culturally-tailored, diabetes educational text messaging has previously improved HbA1c in this population. METHODS: During the pandemic, hospitalized Hispanic adults with T2D (N = 172) were randomized to receive Dulce Digital-COVID Aware ("DD-CA") texting platform upon discharge plus diabetes transition service (DTS) or DTS alone. DD-CA includes diabetes educational messaging with additional COVID-safe messaging (e.g., promoting masking; social distancing; vaccination). FINDINGS: Among adults with poorly-controlled diabetes (Mean HbA1c = 9.6 ± 2.2 %), DD-CA did not reduce 30- or 90-day readmissions compared to standard care (28 % vs 15 %, p = .06; 37 % vs 35 %, p = .9, respectively). However, the improvement in HbA1c was larger among those in the DD-CA compared to DTS at 3 months (n = 56; -2.69 % vs. -1.45 %, p = .0496) with reduced effect at 6 months (n = 64; -2.03 % vs -0.91 %, p = .07). Low follow-up completion rates and the addition of covariates (to control for baseline group differences that existed despite randomization) impacted statistical power. INTERPRETATION: During the pandemic, DD-CA offered an alternative digital approach to diabetes and COVID education and support for a high-risk Hispanic population and achieved trends toward improvement in glycemic control despite relatively low engagement and not reducing hospital readmissions.
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COVID-19 , Diabetes Mellitus Tipo 2 , Envio de Mensagens de Texto , Adulto , Humanos , COVID-19/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Hemoglobinas Glicadas , Hispânico ou Latino , México/epidemiologia , Alta do Paciente , Estados UnidosRESUMO
BACKGROUND: Glycemic control in the hospital setting is imperative for improving outcomes among patients with diabetes. Bedside point-of-care (POC) glucose monitoring has remained the gold standard for decades, while only providing momentary glimpses into a patient's glycemic control. Continuous glucose monitoring (CGM) has been shown to improve glycemic control in the ambulatory setting. However, a paucity of inpatient experience and data remains a barrier to US Food and Drug Administration (FDA) approval and expanded/non-research use in the hospital setting. METHOD: Amid the COVID-19 pandemic, the FDA exercised its enforcement discretion to not object to the use of CGM systems for the treatment of patients in hospital settings to support COVID-19 health care-related efforts to reduce viral exposure of health care workers. Following this announcement, Scripps Health, a large not-for-profit health care system in San Diego, California, implemented CGM as the new "standard of care" (CGM as SOC) for glucose monitoring and management in the hospital. RESULTS: The present report serves to (1) detail the implementation procedures for employing this new SOC; (2) describe the patients receiving CGM as SOC, their glycemic control, and hospital outcomes; and (3) share lessons learned over two years and nearly 900 hospital encounters involving CGM. CONCLUSIONS: Here, we conclude that CGM is feasible in the hospital setting by using a dedicated diabetes care team and the CGM technology with remote monitoring.
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COVID-19 , Diabetes Mellitus Tipo 1 , Diabetes Mellitus , Humanos , Glicemia , Automonitorização da Glicemia/métodos , Pandemias , Diabetes Mellitus/terapia , Hospitais , Diabetes Mellitus Tipo 1/tratamento farmacológicoRESUMO
Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.
Type 2 diabetes disproportionately impacts ethnic minorities, including Hispanic individuals; however, these populations are often underrepresented in clinical research, especially in studies using digital technologies. The Dulce Digital-Me study was developed to provide diabetes self-management education and support using mobile health technologies with the goal of improving clinical outcomes by reducing barriers to accessing support. This analysis revealed that the Dulce Digital-Me study was successful at reaching the target population and engaging them with the intervention, while also delivering the study intervention with high fidelity. This process evaluation provides critical context for understanding the study's clinical outcomes and the potential for further dissemination.
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Diabetes Mellitus Tipo 2 , Telemedicina , Humanos , Diabetes Mellitus Tipo 2/terapia , Pessoal de Saúde , Telemedicina/métodos , Hispânico ou Latino , Educação em SaúdeRESUMO
BACKGROUND: Multimorbidity frequently co-occurs with behavioral health concerns and leads to increased healthcare costs and reduced quality and quantity of life. Unplanned readmissions are a primary driver of high healthcare costs. OBJECTIVE: We tested the effectiveness of a culturally appropriate care transitions program for Latino adults with multiple cardiometabolic conditions and behavioral health concerns in reducing hospital utilization and improving patient-reported outcomes. DESIGN: Randomized, controlled, single-blind parallel-groups. PARTICIPANTS: Hispanic/Latino adults (N=536; 75% of those screened and eligible; M=62.3 years (SD=13.9); 48% women; 73% born in Mexico) with multiple chronic cardiometabolic conditions and at least one behavioral health concern (e.g., depression symptoms, alcohol misuse) hospitalized at a hospital that serves a large, mostly Hispanic/Latino, low-income population. INTERVENTIONS: Usual care (UC) involved best-practice discharge processes (e.g., discharge instructions, assistance with appointments). Mi Puente ("My Bridge"; MP) was a culturally appropriate program of UC plus inpatient and telephone encounters with a behavioral health nurse and community mentor team who addressed participants' social, medical, and behavioral health needs. MAIN MEASURES: The primary outcome was 30- and 180-day readmissions (inpatient, emergency, and observation visits). Patient-reported outcomes (quality of life, patient activation) and healthcare use were also examined. KEY RESULTS: In intention-to-treat models, the MP group evidenced a higher rate of recurrent hospitalization (15.9%) versus UC (9.4%) (OR=1.91 (95% CI 1.09, 3.33)), and a greater number of recurrent hospitalizations (M=0.20 (SD=0.49) MP versus 0.12 (SD=0.45) UC; P=0.02) at 30 days. Similar trends were observed at 180 days. Both groups showed improved patient-reported outcomes, with no advantage in the Mi Puente group. Results were similar in per protocol analyses. CONCLUSIONS: In this at-risk population, the MP group experienced increased hospital utilization and did not demonstrate an advantage in improved patient-reported outcomes, relative to UC. Possible reasons for these unexpected findings are discussed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02723019. Registered on 30 March 2016.
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Doenças Cardiovasculares , Assistência à Saúde Culturalmente Competente , Transição do Hospital para o Domicílio , Transtornos Mentais , Doenças Metabólicas , Multimorbidade , Feminino , Humanos , Masculino , Hispânico ou Latino , Transferência de Pacientes/métodos , Qualidade de Vida , Método Simples-Cego , Pessoa de Meia-Idade , Idoso , Fatores de Risco Cardiometabólico , Readmissão do Paciente , Avaliação das Necessidades , Assistência AmbulatorialRESUMO
Background: The majority of individuals referred to diabetes self-management education and support (DSMES) programs do not access this resource. Of those who do, attrition is high, with anecdotal reports pointing to the didactic and impersonal nature of these programs contributing to low utilization and completion rates. In an effort to develop a more engaging form of DSMES for adults with type 2 diabetes (T2D), we constructed a nondidactic "discovery learning"-based DSMES program centered on real-time flash glucose monitoring (FGM). Methods: In this single-arm pilot study, 35 adults with T2D duration 1-5 years, ages 21-75 years, not using insulin and HbA1c ≥8.0% were introduced to FGM and participated in five weekly group sessions. DSMES content was personalized, emerging from the concerns and questions arising from participants' FGM discoveries. The primary outcome was glycemic change as assessed by blinded FGM at baseline and month 3. Secondary outcomes included psychosocial and behavioral measures. Results: There was a significant gain in percentage time in range (% TIR) 70-180 mg/dL from baseline (55%) to month 3 (74%), and a parallel drop-in percentage time above range (TAR) >180 mg/dL from 44% to 25% (Ps = 0.01). Overall well-being rose significantly (P = 0.04), whereas diabetes distress showed a nonsignificant drop. Participants reported improvements in healthy eating (P < 0.001) and physical activity, although the latter did not reach statistical significance. Conclusions: These findings support a new approach to DSMES, a method that integrates FGM with a highly interactive and engaging patient-driven "discovery learning" approach to education.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Autogestão , Adulto , Humanos , Adulto Jovem , Pessoa de Meia-Idade , Idoso , Diabetes Mellitus Tipo 1/psicologia , Glicemia , Automonitorização da Glicemia/métodos , Projetos PilotoRESUMO
OBJECTIVE: The objective of the study is to identify predictors of utilization of a type 2 diabetes (T2D) management App over time for insulin users (IUs) and noninsulin users (NIUs). RESEARCH DESIGN AND METHODS: We followed over 16 weeks a national sample of unselected T2D adults who independently elected to download and pair a CONTOUR DIABETES App with their CONTOUR NEXT ONE glucose meter. App use and frequency of glucose testing were recorded. Baseline surveys recorded participant demographic, disease status, distress, medication taking, and views of technology to predict utilization. RESULTS: Mean age was 51.6 years (108 IUs; 353 NIUs), 48% were female, time with diabetes was 6.9 years, and self-reported HbA1c was 8.1% (36.3 mmol/mol). Mean duration of App use was 85.4 days and 40% stopped using the App before 16 weeks. Continuous users were older and reported higher distress, better medication taking, and more positive attitudes toward technology (all P < .01). IUs tested more frequently than NIUs, but frequency and intensity of testing decreased markedly for both groups over time. More predictors of App use frequency and testing occurred for NIUs than IUs: older age, higher HbA1c, lower distress, more medication taking (all P < .05). CONCLUSIONS: App use and testing decreased markedly over time. Variations in the predictors of frequency of App use suggest that the utilization of mobile technologies requires a tailored approach that addresses the specific needs of individual users, compared with adopting a one-size-fits-all strategy, and that IUs and NIUs may require very different strategies of customization.
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Diabetes Mellitus Tipo 2 , Aplicativos Móveis , Humanos , Adulto , Feminino , Pessoa de Meia-Idade , Masculino , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas , Insulina , GlucoseRESUMO
OBJECTIVE: Evaluations of technology to help adults manage type 2 diabetes (T2D) have yielded mixed results. We analyzed the effectiveness of a free app linked to a glucose meter to study reductions in glucose levels over time among a self-selected sample of adults with T2D. RESEARCH DESIGN AND METHODS: Adults with T2D >12 months, >21 years, ability to read English (insulin using-IU and non-insulin using-NIU) who independently elected to pair their CONTOUR NEXT ONE meter with the CONTOUR DIABETES App were invited to participate. Glucose data from baseline to 16 weeks were uploaded to the cloud (N = 461). Assessment of diabetes distress, medication taking, quality of life, and hypoglycemia concerns occurred at baseline, six, and 16 weeks. RESULTS: Findings indicated a significant decrease in weekly glucose levels over time: baseline mean = 169 (62.0) (9.4 mmol/L; 3.44); 16-week mean = 146.5 (36.0) (8.1 mmol/L; 2.0) (P < .001), with no IU and NIU differences. Largest reductions occurred during the first six weeks, with no later rebound effects. Significant, though modest, improvements in global quality of life (P = .03), hypoglycemia concerns (P = .01), and diabetes distress (P < .001) occurred over 16 weeks. CONCLUSIONS: Making an App for monitoring glucose easily available for download with a glucose meter can be helpful for self-selected adults with T2D. Effective utilization assumes that users are sufficiently motivated and engaged, are comfortable and trusting of the technology, and have sufficient knowledge of how to make use of the glucose data.
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Background: To explore whether regularly reviewing one's own retrospective continuous glucose monitoring (CGM) data might be linked with perceived quality of life (QoL) and glycemic benefits. Methods: Adults with type 1 diabetes (N = 300) or insulin-using type 2 diabetes (N = 198) using the Dexcom G5 Mobile or G6 Real-Time CGM (RT-CGM) system and receiving the weekly CLARITY summary report of their glucose data completed a survey exploring their use of the report and its perceived value and impact on QoL and glycemic outcomes. Regression analyses examined whether personal use of the report was associated with QoL, perceived glycemic outcomes, and RT-CGM metrics. Results: The majority reported that receiving and viewing the report contributed to improved hypoglycemic confidence (75.9%) and overall well-being (50.0%), reduced diabetes distress (59.3%-74.1%), and helped to improve A1C (73.1%) and reduce problems with hypoglycemia (61.8%) and chronic hyperglycemia (73.1%). Regularly reviewing the report with family or friends (positive predictor) and doing nothing with the report's information (negative predictor) were independently associated with QoL and perceived glycemic outcomes. Surprisingly, both predictors were also associated with poorer glycemic control (e.g., greater % time above range >180). Conclusions: These findings suggest that receiving a weekly RT-CGM summary report may contribute to QoL and health benefits, especially if the individual chooses to actively review and make use of the report's findings and openly reviews the findings with family or friends. Prospective studies are needed to more precisely determine how retrospective RT-CGM data summaries can best be presented and utilized effectively by adults with diabetes to enhance health outcomes.
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Automonitorização da Glicemia , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Adulto , Glicemia , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas/análise , Humanos , Avaliação de Resultados em Cuidados de Saúde , Qualidade de Vida , Estudos RetrospectivosRESUMO
BACKGROUND: By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change. METHODS: This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions. DISCUSSION: Our comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability. TRIAL REGISTRATION: NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .
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Diabetes Mellitus Tipo 2 , Telemedicina , Envio de Mensagens de Texto , Adulto , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Hemoglobinas Glicadas/análise , Hispânico ou Latino , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Team-based models that use medical assistants (MAs) to provide self-management support for adults with type 2 diabetes (T2D) have not been pragmatically tested in diverse samples. This cluster-randomized controlled trial compares MA health coaching with usual care in adults with T2D and poor clinical control ("MAC Trial"). The purpose was to conduct a multi-method process evaluation of the MAC Trial using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach was assessed by calculating the proportion of enrolled participants out of the eligible pool and examining representativeness of those enrolled. Key informant interviews documented adoption by MA Health Coaches. We examined implementation from the research and patient perspectives by evaluating protocol adherence and the Patient Perceptions of Chronic Illness Care (PACIC-SF) measure, respectively. Findings indicate that the MAC Trial was efficient and effective in reaching patients who were representative of the target population. The acceptance rate among those approached for health coaching was high (87%). Both MA Health Coaches reported high satisfaction with the program and high levels of confidence in their role. The intervention was well-implemented, as evidenced by the protocol adherence rate of 79%; however, statistically significant changes in PACIC-SF scores were not observed. Overall, if found to be effective in improving clinical and patient-reported outcomes, the MAC model holds potential for wider-scale implementation given its successful adoption and implementation and demonstrated ability to reach patients with poorly controlled T2D who are at-risk for diabetes complications in diverse primary care settings.
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Diabetes Mellitus Tipo 2 , Tutoria , Autogestão , Adulto , Diabetes Mellitus Tipo 2/terapia , Humanos , Atenção Primária à Saúde/métodosRESUMO
BACKGROUND: To examine caregivers' experiences with real-time continuous glucose monitoring (RT-CGM) data sharing and its impact on quality of life (QoL) and health outcomes. METHODS: Parents of children with type 1 diabetes (T1D) (N = 303) and spouses/partners of T1D adults (N = 212) using the Dexcom G5 Mobile or G6 RT-CGM system and who were actively following their T1Ds' RT-CGM data completed a survey examining their perceived value of data sharing, the impact of sharing on their own QoL and their child/partner's health, and how they used RT-CGM data to support their T1Ds' diabetes management. Regression analyses examined whether their actions were linked to reported changes in QoL and health outcomes. RESULTS: Respondents were predominantly non-Hispanic White (91.1% parents; 88.7% partners), female (78.2% parents; 54.7% partners), and college-educated (65.3% parents; 61.8% partners). The majority reported that data sharing had enhanced hypoglycemic confidence (97.7% parents; 98.1% partners), overall well-being (60.4% parents; 63.2% partners), and sleep quality (78.0% parents; 61.3% partners). Of note, three positive caregiver actions were broadly consistent and significant predictors of QoL and health benefits for both parents and partners: celebrating success related to glycemic control, providing encouragement when glycemic control is challenging, and teamwork discussions about how the caregiver should respond to out-of-range values. CONCLUSIONS: RT-CGM data sharing was associated with a range of QoL and health benefits for caregivers. Degree of benefits was influenced by the collaborative actions taken by caregivers to support their child's or partner's diabetes management. To determine the most effective strategies for collaborative data sharing, longitudinal trials are needed.
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Diabetes Mellitus Tipo 1 , Qualidade de Vida , Adulto , Glicemia , Automonitorização da Glicemia , Cuidadores , Criança , Diabetes Mellitus Tipo 1/complicações , Feminino , Humanos , Disseminação de InformaçãoRESUMO
In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. "Team-based" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or "health coaching." While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among Nâ¯=â¯600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (nâ¯=â¯300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.
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Diabetes Mellitus Tipo 2 , Tutoria , Adulto , Pessoal Técnico de Saúde , Diabetes Mellitus Tipo 2/terapia , Etnicidade , Humanos , Grupos Minoritários , Atenção Primária à Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , AutocuidadoRESUMO
Background: To examine experiences with real-time continuous glucose monitoring (RT-CGM) data sharing and its impact on health-related outcomes. Methods: Adults with type 1 diabetes (T1D) (N = 302) using the Dexcom G5 Mobile or G6 RT-CGM system and sharing data with ≥1 family/friend follower completed a survey exploring their perceived value of data sharing, the impact of sharing on health and quality of life (QoL) outcomes, and how their chief follower (CF) used shared data to support their diabetes management. Regression analyses examined whether CF actions were linked to reported changes in health and QoL outcomes for the T1D adult. Results: The majority had lived with T1D >10 years, (76.5%), used RT-CGM >1 year (58.0%), and identified their spouse/partner as CF (51.9%). Data sharing reportedly contributed to improved hypoglycemic confidence (for 89.4% of respondents), improved overall well-being (54.3%), and reduced diabetes distress (36.1%). Benefits related to data sharing included fewer episodes of severe hypoglycemia (62.2%), better sleep (52.4%), and A1C improvement (47.3%). In particular, three positive CF actions were independent predictors of health and QoL benefits: celebrating success related to glycemic control, providing encouragement when glycemic control is challenging, and teamwork discussions about how CF should respond to out-of-range values. Conclusions: RT-CGM data sharing was associated with a range of health and QoL-related benefits. The occurrence of benefits was influenced by the collaborative management approaches taken by RT-CGM users and their data-sharing followers. Longitudinal trials are needed to determine the most effective patterns of collaborative data sharing, leading to their implementation into routine diabetes management.
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Diabetes Mellitus Tipo 1 , Qualidade de Vida , Adulto , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Hipoglicemiantes , Disseminação de Informação , Avaliação de Resultados em Cuidados de SaúdeRESUMO
OBJECTIVE: The current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial of real-time continuous glucose monitoring (RT-CGM) compared with POC in a non-intensive care unit (ICU) hospital setting. RESEARCH DESIGN AND METHODS: A total of 110 adults with type 2 diabetes on a non-ICU floor received RT-CGM with Dexcom G6 versus usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions. RESULTS: The RT-CGM group demonstrated significantly lower mean glucose (M∆ = -18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (-11.41%) and higher time in range 70-250 mg/dL (+11.26%) compared with UC (P values <0.05). Percentage of time in hypoglycemia was very low. CONCLUSIONS: RT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management. Continuously streaming glucose readings may truly be the fifth vital sign.
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PURPOSE: The purpose of this study was to examine whether baseline levels of diabetes distress (DD) impacted clinical benefit from a mobile health (mHealth) diabetes self-management education and support (DSME/S) intervention ("Dulce Digital"). METHODS: This secondary analysis included the full sample of 126 Hispanic adults (mean age = 48.43 years, SD = 9.80) with type 2 diabetes and glycosylated hemoglobin A1C >7.5% enrolled from a Federally Qualified Health Center in a randomized, nonblinded clinical trial that compared Dulce Digital to usual care. Dulce Digital participants received educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months. RESULTS: Baseline levels of DD prospectively moderated the effect of Dulce Digital (vs usual care) on glycemic control over 6 months, such that Dulce Digital participants with higher DD experienced relatively greater benefit from the intervention. The effect of the intervention on A1C change was 178% larger among individuals experiencing moderate/high versus no/low DD. CONCLUSIONS: Although research has found DD to be associated with poorer self-management and clinical outcomes, individuals already distressed about their diabetes may benefit from a lower-burden mHealth DSME/S approach.
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Diabetes Mellitus Tipo 2/psicologia , Controle Glicêmico/psicologia , Autogestão/psicologia , Estresse Psicológico/sangue , Telemedicina/estatística & dados numéricos , Adulto , Automonitorização da Glicemia/psicologia , Automonitorização da Glicemia/estatística & dados numéricos , Diabetes Mellitus Tipo 2/sangue , Feminino , Hemoglobinas Glicadas/análise , Controle Glicêmico/métodos , Educação em Saúde/métodos , Hispânico ou Latino/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Autogestão/métodos , Estresse Psicológico/etiologia , Envio de Mensagens de Texto , Resultado do TratamentoRESUMO
BACKGROUND: Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafter, Latinos) and other ethnic minorities are more vulnerable to these conditions, and face structural, social, and cultural barriers to obtaining quality physical and behavioral healthcare. We report the protocol for a randomized controlled trial that will compare Mi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to which Mi Puente produces superior reductions in hospital utilization at 30 and 180 days (primary aim) and better patient-reported outcomes (quality of life/physical health; barriers to healthcare; engagement with outpatient care; patient activation; resources for chronic disease management), and will examine the cost effectiveness of the Mi Puente intervention relative to usual care. METHODS: Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings. After providing written informed consent and completing self-report assessments, participants randomized to usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance) as required. Those randomized to Mi Puente receive usual-care materials and processes, along with inpatient visits and up to 4 weeks of follow-up phone calls from the intervention team to address their integrated physical-behavioral health needs and support the transition to outpatient care. DISCUSSION: The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns. If shown to be effective, close linkages with outpatient healthcare and community organizations will help maximize uptake, dissemination, and scaling of the Mi Puente intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02723019. Registered on 30 March 2016.
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Transtornos de Ansiedade/terapia , Assistência à Saúde Culturalmente Competente/métodos , Hispânico ou Latino , Transtornos do Humor/terapia , Multimorbidade , Transferência de Pacientes/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Análise Custo-Benefício , Feminino , Seguimentos , Comportamentos Relacionados com a Saúde/etnologia , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Medidas de Resultados Relatados pelo Paciente , Transferência de Pacientes/economia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Encaminhamento e Consulta , Provedores de Redes de Segurança , Telefone , Estados Unidos , Adulto JovemRESUMO
Despite significant treatment advances, diabetes outcomes remain suboptimal and health care costs continue to rise. There are limited data on the feasibility and financial implications of integrating a diabetes-specific care team in the primary care setting (ie, where the majority of diabetes is treated). This pragmatic quality improvement project investigated whether a cardiometabolic care team intervention (CMC-TI) could achieve greater improvements in clinical, behavioral, and cost outcomes compared to usual diabetes care in a large primary care group in Southern California. Over 12 months, n = 236 CMC-TI and n = 239 usual care patients with type 1 or 2 diabetes were identified using the electronic medical record. In the CMC-TI group, a registered nurse (RN)/certified diabetes educator care manager, medical assistant health coach, and RN depression care manager utilized electronic medical record-based risk stratification reports, standardized decision-support tools, live and remote tailored treatments, and coaching to manage care. Results indicated that the CMC-TI group achieved greater improvements in glycemic and lipid control, diabetes self-management behaviors, and emotional distress over 1 year compared with the usual care group (all P < .05). The CMC-TI group also had a significant 12.6% reduction in total health care costs compared to a 51.7% increase in the usual care group during the same period and inclusive of CMC-TI program costs. Patients and providers reported high satisfaction with CMC-TI. These findings highlight that team-based care management interventions that utilize nurses, medical assistant health coaches, and behavioral specialists to support diabetes patients can help primary care practices achieve value-based targets of improved health, cost, and patient experience.
Assuntos
Diabetes Mellitus Tipo 2 , Glicemia , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Equipe de Assistência ao Paciente , Atenção Primária à SaúdeRESUMO
Background: Hypoglycemic confidence (HC) represents the degree to which an individual feels secure regarding his or her ability to stay safe from hypoglycemia-related problems. Self-report scales assessing HC in adults with type 1 diabetes (T1D) have found that greater HC is associated with better glycemic control and that HC rises significantly after real-time continuous glucose monitoring is introduced. To determine whether HC might be similarly meaningful in the partners of T1D adults, we developed the Hypoglycemic Confidence Scale for Partners (Partner-HCS). This article describes the construction and validation of the Partner-HCS and examines how HC in T1D partners is related to hypoglycemia-related experience and key psychosocial constructs. Methods: Items were developed from interviews with seven T1D partners, resulting in 12 self-report items. Exploratory factor analysis (EFA) was then conducted on data collected from T1D partners (n = 218). Variables to establish construct validity for the Partner-HCS included partner-reported diabetes distress, hypoglycemic fear, generalized anxiety, and confidence regarding glucagon use, as well as frequency of recent severe hypoglycemia in the T1D adult. Hierarchical regression analyses examined the unique contribution of Partner-HCS scores, independent of hypoglycemic fear, to key psychosocial constructs and hypoglycemia-related factors. Results: EFA of the 12 items yielded a single-factor solution, accounting for 51.2% of the variance. Construct validity was demonstrated by significant univariate associations with key psychosocial constructs. Importantly, Partner-HCS total score was, independent of hypoglycemic fear, significantly associated with diabetes distress (P < 0.05), overall relationship satisfaction (P = 0.004), number of severe hypoglycemic episodes in the last 6 months (P < 0.05), and confidence using glucagon (P = 0.007). In total, 38.5% of T1D partners indicated relatively low HC. Conclusions: HC is an important facet of the experiences of T1D partners. It is related to, yet distinct from, hypoglycemic fear. The Partner-HCS is a reliable, valid method for assessing HC in partners of T1D adults.
Assuntos
Ansiedade/psicologia , Automonitorização da Glicemia/psicologia , Diabetes Mellitus Tipo 1/psicologia , Hipoglicemia/prevenção & controle , Cônjuges/psicologia , Estresse Psicológico/psicologia , Adulto , Ansiedade/diagnóstico , Diabetes Mellitus Tipo 1/complicações , Análise Fatorial , Medo , Feminino , Glucagon/uso terapêutico , Humanos , Hipoglicemia/psicologia , Hipoglicemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Escalas de Graduação Psiquiátrica , Pesquisa Qualitativa , Análise de Regressão , Reprodutibilidade dos Testes , Autorrelato , Estresse Psicológico/diagnósticoRESUMO
IN BRIEF In the United States, Hispanics have a 66% greater risk of developing type 2 diabetes and, once diagnosed, exhibit worse outcomes than non-Hispanic whites. It is therefore imperative to ensure that interventions meet the specific needs of this at-risk group. This article provides a selective review of the evidence on innovative, real-world approaches (both live and technology-based) to improving behavioral, psychosocial, and clinical outcomes in underserved Hispanics with type 2 diabetes. Key aspects of successful live interventions have included multimodal delivery, greater dosage/attendance, and at least some in-person delivery; effective technology-based approaches involved frequent but intermittent communication, bi-directional messaging, tailored feedback, multimodal delivery, and some human interaction. Across modalities, cultural tailoring also improved outcomes. Additional research is needed to address methodological limitations of studies to date and pinpoint the most efficacious components and optimal duration of interventions. Future efforts should also attend to variability within the U.S. Hispanic population to ensure acceptability and sustainability of interventions in this diverse group.