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Shared Medical Appointments and Mindfulness for Type 2 Diabetes-A Mixed-Methods Feasibility Study.

ABSTRACT: Introduction:Type 2 diabetes (T2DM) is a major health concern with significant personal and healthcare system costs. There is growing interest in using shared medical appointments (SMAs) for management of T2DM. We hypothesize that adding mindfulness to SMAs may be beneficial. This study aimed to assess the feasibility and acceptability of SMAs with mindfulness for T2DM within primary care in Australia. Materials and Methods:We conducted a single-blind randomized controlled feasibility study of SMAs within primary care for people with T2DM living in Western Sydney, Australia. People with T2DM, age 21 years and over, with HbA1c > 6.5% or fasting glucose >7.00 mmol/L within the past 3 months were eligible to enroll. The intervention group attended six 2-h programmed SMAs (pSMAs) which were held fortnightly. pSMAs included a structured education program and mindfulness component. The control group received usual care from their healthcare providers. We collected quantitative and qualitative data on acceptability as well as glycemic control (glycated hemoglobin and continuous glucose monitoring), lipids, anthropometric measures, blood pressure, self-reported psychological outcomes, quality of life, diet, and physical activity using an ActiGraph accelerometer. Results:Over a 2-month period, we enrolled 18 participants (10 females, 8 males) with a mean age of 58 years (standard deviation 9.8). We had 94.4% retention. All participants in the intervention group completed at least four pSMAs. Participants reported that attending pSMAs had been a positive experience that allowed them to accept their diagnosis and empowered them to make changes, which led to beneficial effects including weight loss and better glycemic control. Four pSMA participants found the mindfulness component helpful while two did not. All of the seven participants who contributed to qualitative evaluation reported improved psychosocial wellbeing and found the group setting beneficial. There was a significant difference in total cholesterol levels at 12 weeks between groups (3.86 mmol/L in intervention group vs. 4.15 mmol/L in the control group; p = 0.025) as well as pain intensity levels as measured by the PROMIS-29 (2.11 vs. 2.38; p = 0.034). Conclusion:pSMAs are feasible and acceptable to people with T2DM and may result in clinical improvement. A follow-up fully-powered randomized controlled trial is warranted. Clinical Trial Registration:Australia and New Zealand Clinical Trial Registry, identifier ACTRN12619000892112.

SUBMITTER: Ee C

PROVIDER: S-EPMC7573307 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Shared Medical Appointments and Mindfulness for Type 2 Diabetes-A Mixed-Methods Feasibility Study.

Ee Carolyn C de Courten Barbora B Avard Nicole N de Manincor Michael M Al-Dabbas Mahmoud A MA Hao Jie J McBride Kate K Dubois Shamieka S White Rhiannon Lee RL Fleming Catharine C Egger Garry G Blair Angela A Stevens John J MacMillan Freya F Deed Gary G Grant Suzanne S Templeman Kate K Chang Dennis D

Frontiers in endocrinology 20201006

<h4>Introduction</h4>Type 2 diabetes (T2DM) is a major health concern with significant personal and healthcare system costs. There is growing interest in using shared medical appointments (SMAs) for management of T2DM. We hypothesize that adding mindfulness to SMAs may be beneficial. This study aimed to assess the feasibility and acceptability of SMAs with mindfulness for T2DM within primary care in Australia.<h4>Materials and methods</h4>We conducted a single-blind randomized controlled feasibi ...[more]

PMID: 33123089

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Project description:ObjectivesShared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes.Data sourcesMEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from January 1996 through April 2012. PubMed search updated June 2013.Study selectionEnglish-language peer-reviewed publications of randomized controlled trials (RCTs), nonrandomized cluster controlled trials, controlled before-and-after studies, or interrupted time-series designs conducted among adult patients with diabetes. Two independent reviewers used prespecified criteria to screen titles and abstracts for full text review.Study appraisal and synthesis methodsTwo different reviewers abstracted data and rated study quality and strength of evidence. When possible, we used random-effects models to synthesize the effects quantitatively, reporting by a weighted difference of the means when the same scale was used across studies, and a standardized mean difference when the scales differed. We measured heterogeneity in study effects using Forest Plots, Cochran's Q, and I(2), and explored heterogeneity by using subgroup analyses for categorical variables and meta-regression analyses for continuous or discrete variables. Outcomes not suitable to meta-analysis were summarized qualitatively.ResultsTwenty-five articles representing 17 unique studies compared SMA interventions with usual care. Among patients with diabetes, SMAs improved hemoglobin A1c (? = -0.55 percentage points [95 % CI, -0.11 to -0.99]); improved systolic blood pressure (? = -5.2 mmHg [95 % CI, -3.0 to -7.4]); and did not improve LDL cholesterol (? = -6.6 mg/dl [95 % CI, 2.8 to -16.1]). Nonbiophysical outcomes, including economic outcomes, were reported too infrequently to meta-analyze, or to draw conclusions from. The A1c result had significant heterogeneity among studies, likely secondary to the heterogeneity among included SMA interventions.LimitationHeterogeneity among the components of diabetes SMAs leads to uncertainty about what makes a particular SMA successful.ConclusionSMA interventions improve biophysical outcomes among patients with diabetes. There was inadequate literature to determine SMA effects on patient experience, utilization, and costs.

Project description:BackgroundShared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes.MethodsThis study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability.DiscussionPractice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model.Trial registrationClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

Project description:BackgroundImmersive virtual reality (VR) is a promising therapy to improve the experience of patients with critical illness and may help avoid postdischarge functional impairments. However, the determinants of interest and usability may vary locally and reports of uptake in the literature are variable.ObjectiveThe aim of this mixed methods feasibility study was to assess the acceptability and potential utility of immersive VR in critically ill patients at a single institution.MethodsAdults without delirium who were admitted to 1 of 2 intensive care units were offered the opportunity to participate in 5-15 minutes of immersive VR delivered by a VR headset. Patient vital signs, heart rate variability, mood, and pain were assessed before and after the VR experience. Pre-post comparisons were performed using paired 2-sided t tests. A semistructured interview was administered after the VR experience. Patient descriptions of the experience, issues, and potential uses were summarized with thematic analysis.ResultsOf the 35 patients offered the chance to participate, 20 (57%) agreed to partake in the immersive VR experience, with no difference in participation rate by age. Improvements were observed in overall mood (mean difference 1.8 points, 95% CI 0.6-3.0; P=.002), anxiety (difference of 1.7 points, 95% CI 0.8-2.7; P=.001), and pain (difference of 1.3 points, 95% CI 0.5-2.1; P=.003) assessed on 1-10 scales. The heart rate changed by a mean of -1.1 (95% CI -0.3 to -1.9; P=.008) beats per minute (bpm) from a baseline of 86.1 (SD 11.8) bpm and heart rate variability, assessed by the stress index (SI), changed by a mean of -5.0 (95% CI -1.5 to -8.5; P=.004) seconds-2 from a baseline SI of 40.0 (SD 23) seconds-2. Patients commented on the potential for the therapy to address pain, lessen anxiety, and facilitate calmness. Technical challenges were minimal and there were no adverse effects observed.ConclusionsPatient acceptance of immersive VR was high in a mostly medical intensive care population with little prior VR experience. Patients commented on the potential of immersive VR to ameliorate cognitive and emotional symptoms. Investigators can consider integrating minimally modified commercial VR headsets into the existing intensive care unit workflow to further assess VR's efficacy for a variety of endpoints.

Project description:BackgroundCancer is highly prevalent worldwide and can cause high levels of distress in patients, which is often neglected in medical care. Smartphone apps are readily available and therefore seem promising to deliver distress-reducing interventions such as mindfulness and relaxation programs.ObjectiveThis study aimed to evaluate the feasibility of a mindfulness and relaxation app for cancer patients. We looked at characteristics of participating patients in a mobile health (mHealth) study, including adherence to the app intervention, predictors for adherence, and patients' feedback regarding the app.MethodsIn this prospective observational study with a mixed-methods approach, cancer patients received a mindfulness and relaxation self-care app. Cancer patients were recruited online and through hospitals in Switzerland. We assessed self-reported measures (eg, quality of life, anxiety, depressive symptoms, openness to experience, resistance to change) at baseline, and the app gathered data on patients' practicing time. With 8 semistructured interviews, we obtained patients' feedback about the app and recommendations for improvements. We looked at 3 dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework (reach, adoption, and maintenance) and analyzed data for adherence for the first 10 weeks of the app intervention. We report descriptive statistics for patient characteristics and app use. For the prediction of adherence, we used Kaplan-Meier analyses with log-rank tests and a Cox proportional hazards regression.ResultsData from 100 cancer patients (74 female) showed that 54 patients were using the app exercises continuously until week 10. In continuous app users, the median number of exercises per week dropped from 4 (interquartile range, IQR 1-7) at week 1 to a median of 2 (IQR 1-4) at week 10. Our analyses revealed 4 significant predictors for better adherence: female gender, higher openness to experience, higher resistance to change, and more depressive symptoms. Interviews revealed that the patients generally were satisfied with the app but also made suggestions on how to improve it.ConclusionsOur study indicates that a mindfulness and relaxation mHealth intervention for cancer patients is feasible with acceptable adherence and largely positive feedback from patients.Trial registrationGerman Clinical Trials Register DRKS00010481; https://www.drks.de/drks_web/navigate.do?navigation Id=trial.HTML&TRIAL_ID=DRKS00010481 (Archived by WebCite at http://www.webcitation.org/73xGE1B0P).

Dataset Information

Shared Medical Appointments and Mindfulness for Type 2 Diabetes-A Mixed-Methods Feasibility Study.

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Shared Medical Appointments and Mindfulness for Type 2 Diabetes-A Mixed-Methods Feasibility Study.

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