To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education.
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SUBMITTER: Schinckus L
PROVIDER: S-EPMC8069177 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPatients with type 2 diabetes require recommendations for self-management education and support.ObjectiveIn this study, we aim to design the Diabetes Engagement and Activation Platform (DEAP)-an automated patient education tool integrated into primary care workflow-and examine its implementation and effectiveness.MethodsWe invited patients aged 18-85 years with a hemoglobin A1c (HbA1c) level ≥8 to participate in a randomized controlled trial comparing DEAP with usual care. DEAP modules addressing type 2 diabetes self-management education and support domains were programmed into patient portals, each with self-guided educational readings, videos, and questions. Care teams received patient summaries and were alerted to patients with low confidence or requesting additional help. HbA1c, BMI, and systolic and diastolic blood pressure (DBP) were measured.ResultsOut of the 680 patients invited to participate, 337 (49.5%) agreed and were randomized. All of the 189 intervention patients accessed the first module, and 140 patients (74.1%) accessed all 9 modules. Postmodule knowledge and confidence scores were high. Only 18 patients requested additional help from the care team. BMI was lower for intervention patients than controls at 3 months (31.7 kg/m2 vs 32.1 kg/m2; P=.04) and 6 months (32.5 kg/m2 vs 33.0 kg/m2; P=.003); improvements were even greater for intervention patients completing at least one module. There were no differences in 3- or 6-month HbA1c or blood pressure levels in the intent-to-treat analysis. However, intervention patients completing at least one module compared with controls had a better HbA1c level (7.6% vs 8.2%; P=.03) and DBP (72.3 mm Hg vs 75.9 mm Hg; P=.01) at 3 months.ConclusionsThe findings of this study concluded that a significant proportion of patients will participate in an automated virtual diabetes self-management program embedded into patient portals and health systems show promise in helping patients manage their diabetes, weight, and blood pressure.Trial registrationClinicalTrials.gov NCT02957721; https://clinicaltrials.gov/ct2/show/NCT02957721.
| S-EPMC8088852 | biostudies-literature
Project description:Objectives: Marshallese are a Pacific Islander community that experience a disproportionate rate of type 2 diabetes. The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an Adapted-Family Diabetes Self-Management Education (DSME) intervention among Marshallese adults diagnosed with type 2 diabetes and their family members when delivered in a clinical setting. Methods: Marshallese patients (primary participants) with type 2 diabetes (n = 10) and their family members (n = 10) enrolled in a pilot study deigned to evaluate an Adapted-Family DSME curriculum conducted by community health workers and a certified diabetes educator in a clinical setting. Primary and family participants' health information and biometric data (HbA1c, blood pressure, cholesterol, and body mass index) were collected at preintervention and 12 weeks postintervention. Results: All 10 primary participants and 8 of the family members received all 10 hours of the education intervention. Nine of the 10 primary participants and 8 of the 10 family members completed the pre- and postintervention data collection events. Primary participants demonstrated a mean decrease in HbA1c of 0.7%, from pre- to postintervention, as well as improved blood pressure and cholesterol. Family members demonstrated minor improvements in HbA1c and blood pressure. Conclusions: Results suggest preliminary effectiveness and feasibility of the Adapted-Family DSME in a clinic setting and will inform implementation of a fully powered study.
| S-EPMC7288836 | biostudies-literature
Project description:BackgroundHealthcare professionals' person-centered communication skills are pivotal for delivering successful diabetes education. Many healthcare professionals favor person-centeredness as a concept, but implementation in practice remains challenging. Today, programs have often a fixed curriculum dominated by biomedical issues. Most person-centered methods are developed targeting individual consultations, although group-based programs are a widespread and efficient method of support. Person-centeredness in group-based programs requires a change in practice towards addressing biopsychosocial issues and facilitating group processes. The objective of this study was to explore how healthcare professionals implement new approaches to facilitate group-based, person-centered diabetes education targeting people with type 2 diabetes.MethodsThe study was guided by action research and divided into three studies: investigation, development, and pilot using a variety of qualitative methods. In the first study; observations across five settings were conducted. Forty-nine group participants and 13 professionals took part; the focus was to investigate approaches that supported or hindered person-centeredness in groups. Observations were supplemented by interviews (n = 12) and two focus groups (n = 16) with group participants, as well as interviews (n = 5) with professionals. In the second study; 14 professionals collaborated in two workshops to develop new approaches. In the third study, new approaches were pilot-tested using observations in three settings. Twenty-five group participants and five professionals took part. The analysis of the pilot test led to the final workshop where six professionals took part.ResultsImplementation was characterized by three categories. Some professionals chose not to implement the methods because they conflicted with their practice relying on the biomedical model. Other incorporated some approaches but was unable to structure the process, leaving participants uncertain about the aim. Finally, one setting succeeded with implementation, tailoring content and processes to group participants' needs.ConclusionThe use of action research created context-sensitive approaches and increased professionals' readiness to implement. More attention should be paid to systematic training of professionals. Training should be structured stepwise incorporating techniques directed towards existing skills including ample time to train and reiterate skills.
| S-EPMC6558764 | biostudies-literature
Project description:OBJECTIVE:To compare the effectiveness of different approaches to nutrition education in diabetes self-management education and support (DSME/S). METHODS:We randomized 150 adults with type 2 diabetes to either certified diabetes educator (CDE)-delivered DSME/S with carbohydrate gram counting or the modified plate method versus general health education. The primary outcome was change in HbA1C over 6 months. RESULTS:At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34]. Change in HbA1C from baseline between the control and intervention groups was not significant at 6 months (carbohydrate counting, P=0.36; modified plate method, P=0.08). In a pre-specified subgroup analysis of patients with a baseline HbA1C 7-10%, change in HbA1C from baseline improved in the carbohydrate counting [-0.86% (-1.47, -0.26), P=0.006] and plate method groups [-0.76% (-1.33, -0.19), P=0.01] compared to controls. CONCLUSION:CDE-delivered DSME/S focused on carbohydrate counting or the modified plate method improved glycemic control in patients with an initial HbA1C between 7 and 10%. PRACTICE IMPLICATIONS:Both carbohydrate counting and the modified plate method improve glycemic control as part of DSME/S.
| S-EPMC4931976 | biostudies-literature
Project description:BackgroundComplex interventions such as self-management courses are difficult to evaluate due to the many interacting components. The way complex interventions are delivered can influence the effect they have for patients, and can impact the interpretation of outcomes of clinical trials. Implementation fidelity evaluates whether complex interventions are delivered according to protocol. Such assessments have been used for one-to-one psychological interventions; however, the science is still developing for group interventions.MethodsWe developed and tested an instrument to measure implementation fidelity of a two-day self-management course for people with epilepsy, SMILE(UK). Using audio recordings, we looked at adherence and competence of course facilitators. Adherence was assessed by checklists. Competence was measured by scoring group interaction, an overall impression score and facilitator "didacticism". To measure "didacticism", we developed a novel way to calculate facilitator speech using computer software. Using this new instrument, implementation fidelity of SMILE(UK) was assessed on three modules of the course, for 28% of all courses delivered.ResultsUsing the instrument for adherence, scores from two independent raters showed substantial agreement with weighted Kappa of 0.67 and high percent agreement of 81.2%. For didacticism, the results from both raters were highly correlated with an intraclass coefficient of 0.97 (p < 0.0001). We found that the courses were delivered with a good level of adherence (> 50% of scored items received the maximum of 2 points) and high competence. Groups were interactive (mean score: 1.9-2.0 out of 2) and the overall impression was on average assessed as "good". Didacticism varied from 42% to 93% of total module time and was not associated with the other competence scores.ConclusionThe instrument devised to measure implementation fidelity was reproducible and easy to use. The courses for the SMILE(UK) study were delivered with a good level of adherence to protocol while not compromising facilitator competence.Trial registrationISRCTN57937389 .
| S-EPMC5504680 | biostudies-literature
Project description:BackgroundNative Hawaiians and Pacific Islanders (NHPIs) experience a disproportionate burden of type 2 diabetes and related complications. Although diabetes self-management education and support (DSMES) interventions have generally yielded positive results, few NHPIs have been included in these studies, and even fewer studies have been evaluated using a randomized controlled trial design and/or implementation research methods. The purpose of this pilot study was to evaluate implementation outcomes of a culturally adapted diabetes self-management education intervention delivered by peer educators to Native Hawaiians and Pacific Islanders residing in Honolulu, Hawai'i.MethodsIn three study sites, the peer educators and 48 participants randomized to the intervention were invited to participate in the mixed methods implementation research. We used a convergent parallel design to collect implementation data including fidelity, feasibility, acceptability, appropriateness, adoption, and sustainability. Data were collected from class observations, participants' class feedback, and post-intervention focus groups with participants and peer educators.ResultsIn 314 end-of-class feedback surveys, 97% of respondents expressed that they were satisfied or highly satisfied with the class content and activities, 98% reported that the classes and materials were very useful, 94% reported very applicable, and 93% reported materials were culturally appropriate. Respondents identified several aspects of the program as especially enjoyable: interactions with peer educators, meeting in groups, learning about other participants' experiences with diabetes, and the information presented in each class. Major themes that emerged from the end-of-intervention focus groups were the relevance of the educational materials, strategies to manage blood glucose, hands-on activities, cultural aspects of the program, including the stories and analogies used to convey information, and appreciation of the group format and peer educators.ConclusionsResults from this research support a culturally tailored, peer educator approach to DSMES among NHPIs. Delivery of the Partners in Care program is feasible in health care and community settings and is a reimbursable DSMES program.Trial registrationClinicaltrials.gov Identifier: NCT01093924 prospectively registered 01.20.09.
| S-EPMC7576821 | biostudies-literature
Project description:IntroductionAchieving glycaemic targets for people living with diabetes (PLWD) is challenging, especially in settings with limited resources. Programmes need to address gaps in knowledge, skills and self-management. Diabetes Self-Management Education (DSME) is an evidence-based intervention to educate and empower PLWD to improve self-management activities. This protocol describes a pilot study assessing the feasibility, acceptability and effect on clinical outcomes of implementing DSME in clinics caring for people living with insulin-dependent diabetes in Liberia.Methods and analysisOur protocol is a three-phased, mixed-methods, quasi-experimental prospective cohort study. Phase 1 focuses on (a) establishing a Patient Advisory Board and (b) training providers in DSME who provide care for PLWD. In phase 2, clinicians will implement DSME. In phase 3, we will train additional providers who interact with PLWD.We will assess whether this DSME programme can lead to increased provider knowledge of DSME, improvements in diabetes self-management behaviours, glycaemic control, diabetes knowledge and psychosocial well-being, and a reduction in severe adverse events. Primary outcomes of interest are implementation outcomes and change in frequency of self-management behaviours by patients. Secondary outcomes include change in haemoglobin A1c, psychosocial well-being, severe adverse events and change in provider knowledge of DSME.Ethics and disseminationEthical approval was obtained from the University of Liberia Institutional Review Board (IRB) and the Brigham and Women's Hospital IRB. Findings from the study will be shared with local and national clinical and programmatic stakeholders and published in an open-access, peer-reviewed journal.
| S-EPMC9577905 | biostudies-literature
Project description:ObjectiveMarshallese adults experience high rates of type 2 diabetes. Previous diabetes self-management education (DSME) interventions among Marshallese were unsuccessful. This study compared the extent to which two DSME interventions improved glycemic control, measured on the basis of change in glycated hemoglobin (HbA1c).Research design and methodsA two-arm randomized controlled trial compared a standard-model DSME (standard DSME) with a culturally adapted family-model DSME (adapted DSME). Marshallese adults with type 2 diabetes (n = 221) received either standard DSME in a community setting (n = 111) or adapted DSME in a home setting (n = 110). Outcome measures were assessed at baseline, immediately after the intervention, and at 6 and 12 months after the intervention and were examined with adjusted linear mixed-effects regression models.ResultsParticipants in the adapted DSME arm showed significantly greater declines in mean HbA1c immediately (-0.61% [95% CI -1.19, -0.03]; P = 0.038) and 12 months (-0.77% [95% CI -1.38, -0.17]; P = 0.013) after the intervention than those in the standard DSME arm. Within the adapted DSME arm, participants had significant reductions in mean HbA1c from baseline to immediately after the intervention (-1.18% [95% CI -1.55, -0.81]), to 6 months (-0.67% [95% CI -1.06, -0.28]), and to 12 months (-0.87% [95% CI -1.28, -0.46]) (P < 0.001 for all). Participants in the standard DSME arm had significant reductions in mean HbA1c from baseline to immediately after the intervention (-0.55% [95% CI -0.93, -0.17]; P = 0.005).ConclusionsParticipants receiving the adapted DSME showed significantly greater reductions in mean HbA1c immediately after and 12 months after the intervention than the reductions among those receiving standard DSME. This study adds to the body of research that shows the potential effectiveness of culturally adapted DSME that includes participants' family members.
| S-EPMC6489107 | biostudies-literature
Project description:BackgroundDelivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health.ObjectiveThis study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months.MethodsThis randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models.ResultsA total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (-0.04%, 95% CI -0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).ConclusionsThe MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users' HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement.Trial registrationAustralia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662.
| S-EPMC7677021 | biostudies-literature
Project description:BACKGROUND:Self-management is the cornerstone of diabetes care, however, despite the numerous recommendations available for self-management, type-2 diabetes mellitus (T2DM) patients' performance is suboptimal in China. This study aimed to explore the association between self-efficacy and self-management behaviors among Chinese T2DM patients, which might provide evidence to inform effective self-management interventions for these patients. METHODS:A cross-sectional survey was conducted using a multi-stage stratified randomized sampling in Shandong Province, China. The Diabetes Empowerment Scale-Short Form (DES-SF) was used to measure patients' self-efficacy to manage diabetes. Latent class analysis (LCA) was used to explore the observed classes of self-management behaviors (dietary control, physical exercise, regular medication and self-monitoring of blood glucose). A two-class solution for self-management behaviors was tested to be the fittest based on LCA; we labelled active and inactive self-management groups. Univariate and multivariate logistic regression analysis were used to examine the associations between self-efficacy and self-management behaviors. RESULTS:A total of 2166 T2DM patients were included in the analysis. The mean DES-SF score was 31.9 (standard deviation: 5.2). The estimated proportions of T2DM in the active and inactive groups were 54.8% and 45.2%, respectively. The multivariate logistic regression showed that higher DES-SF score was significantly associated with higher possibility of active self-management behaviors (odds ratio = 1.06; 95% confidence interval: 1.04-1.08). CONCLUSIONS:Self-efficacy in managing diabetes is associated with self-management behaviors among Chinese T2DM patients. To improve self-management behaviors, multiple strategies should be conducted to improve patients' self-efficacy.
| S-EPMC6844544 | biostudies-literature