579-P: Behavioral Outcomes of a Digital Health Coaching Program Stratified by Baseline A1C: A Real-World Retrospective Analysis

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 579-P
Author(s):  
MEGAN MARTIN ◽  
JONATHAN PATTERSON ◽  
VANESSIA T. TRAN ◽  
BLAKELY B. OCONNOR ◽  
MATTHEW ALLISON ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Real World ◽  
Digital Health ◽  
Behavioral Outcomes ◽  
Health Coaching

scholarly journals The influence of baseline A1c on digital health coaching outcomes for adults with type 2 diabetes: A real-world retrospective cohort study (Preprint)

2020 ◽  
Author(s):  
Martin Martin ◽  
Jonathan Patterson ◽  
Matt Allison ◽  
Blakely B O’Connor ◽  
Dhiren Patel
Keyword(s):  
Mental Health ◽  
Type 2 Diabetes ◽  
High Risk ◽  
Real World ◽  
Digital Health ◽  
Health Coaching ◽  
Diabetes Distress ◽  
Physical And Mental Health ◽  
Patient Centered

BACKGROUND Digital health coaching is an increasingly common diabetes self-management support strategy for individuals with type 2 diabetes and has been linked to positive mental and physical health outcomes. However, the relationship between baseline risk and outcomes has yet to be evaluated in a real-world setting. OBJECTIVE The purpose of this real-world study was to evaluate trends in digital health coaching outcomes by baseline A1c to better understand which populations may experience the greatest clinical and psychosocial benefit. METHODS Participants were referred to a 12-week digital health coaching program, administered by Pack Health, through their healthcare provider, payer or employer. The program included patient-centered lifestyle counseling and psychosocial support delivered via telephone, text and/or email. Self-reported A1c and weight were collected at baseline and completion. Physical and mental health were assessed using the PROMIS Global Health short form and the Diabetes Distress Scale-2. A retrospective cohort study design was used to evaluate program effect in a convenience sample of participants. Changes in Alc, weight, BMI, physical and mental health were analyzed within three participant cohorts stratified by baseline A1c level. RESULTS Participants with complete A1c datasets (n = 226) were included in the analysis. Participants were 71.68% female, with 61.50% identifying as white and 34.07% as black. Most participants (81.41%) reported a baseline A1c ≥ 7%, and 20.35% were classified as high-risk (A1c > 9%). Across A1c cohorts, the average baseline BMI was 35.83 (SD = 7.79), and the moderate risk cohort (7% ≤ A1c ≤ 9%) reported the highest average (36.6; SD = 7.77). At 12 weeks, patients reported a significant decrease in Alc, and high-risk participants reduced their levels by the greatest margin (2.28 points; P < .0001). Across cohorts, BMI improved by 0.82 (P < .0001), with the moderate risk cohort showing the greatest reduction (-0.88; P < .0001). Overall, participants reported significant improvements for PROMIS scores, with the greatest change occurring in the high-risk cohort for whom physical health improved 3.84 points (P < .001) and mental health improved 3.3 points (P < .001). However, the lowest risk cohort showed the greatest improvements in diabetes distress (-0.76; P < .0052). CONCLUSIONS Acknowledging the limitations in this real-world study design, the results reported here suggest that adults with type 2 diabetes with a high baseline A1c or high BMI may benefit the most from patient-centered digital health coaching programs when compared to their lower risk counterparts. While all participants improved in physical and mental health categories, participants with high A1c experienced the greatest A1c reduction, while individuals with the highest baseline BMI lost the most weight. These results may be used to inform referrals for patients who are more likely to benefit from digital health coaching.

scholarly journals Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

2021 ◽  
pp. 026988112110085
Author(s):  
Robin L Carhart-Harris ◽  
Anne C Wagner ◽  
Manish Agrawal ◽  
Hannes Kettner ◽  
Jerold F Rosenbaum ◽  
...  
Keyword(s):  
Real World ◽  
Best Practice ◽  
Digital Health ◽  
Real World Data ◽  
Treatment Protocols ◽  
World Data ◽  
Cost Efficient ◽  
Personalised Treatment ◽  
New Research ◽  
Confirmatory Trials

Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.

scholarly journals Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015

Drug Safety ◽  
2021 ◽  
Vol 44 (4) ◽  
pp. 447-454 ◽  
Author(s):  
Yasser Albogami ◽  
Amir Sarayani ◽  
Juan M. Hincapie-Castillo ◽  
Almut G. Winterstein
Keyword(s):  
United States ◽  
Retrospective Analysis ◽  
Real World ◽  
The United States ◽  
Fetal Exposure

scholarly journals Real-world data on metabolic effects of PCSK9 inhibitors in a tertiary care center in patients with and without diabetes mellitus

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Laurenz T. Fischer ◽  
Daniel A. Hochfellner ◽  
Lisa Knoll ◽  
Tina Pöttler ◽  
Julia K. Mader ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Real World ◽  
Cardiovascular Events ◽  
Care Center ◽  
Tertiary Care ◽  
Lipid Lowering ◽  
Tertiary Care Center ◽  
Pcsk9 Inhibitors ◽  
Real World Data ◽  
Pcsk9 Inhibitor

Abstract Background The lipid-lowering and positive cardiovascular effect of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors was shown in several studies, hence, they are more widely used in the lipid-lowering management of individuals with high cardiovascular risk. As real-world data are still scarce, specifically in patients with type 2 diabetes (T2D), the aim of this retrospective analysis was to investigate the efficacy of PCSK9 inhibitors in lowering low-density lipoprotein cholesterol (LDL-C) in an outpatient clinic of a tertiary care center in routine care. Methods A retrospective analysis of data extracted from the electronic patient record was performed. Patients who were routinely prescribed with PCSK9 inhibitor therapy (alirocumab or evolocumab) during the years 2016 and 2019 were included in the analysis. Characteristics of the patient population, the effects on LDL-C and HbA1c levels as well as subsequent cardiovascular events were assessed over an observation period of 18 months. Results We identified 237 patients treated with PCSK9 inhibitors between January 2016 and September 2019. Almost all patients (97.5%) received PCSK9 inhibitors for secondary prevention. 26.2% of the population had a concomitant diabetes diagnosis. Intolerance to statins (83.1%), ezetimibe (44.7%) or both agents (42.6%) was reported frequently. Three months after initiation of PCSK9 inhibitor therapy, 61.2% of the patients achieved LDL-C levels < 70 mg/dl, and 44.1% LDL-C levels < 55 mg/dl. The median LDL-C was lowered from 141 mg/dl at baseline, to 60 mg/dl after 3 months and 66 mg/dl after 12 months indicating a reduction of LDL-C as follows: 57.5% after 3 months and 53.6% after 12 months. After 3 months of observation, target achievement of LDL-C was higher in patients with T2D compared to non-diabetes patients; < 55 mg/dl: 51% vs. 41.5%; < 70 mg/dl 69.4 vs. 58.5%. After 12 months even more pronounced target LDL achievement in T2D was demonstrated < 55 mg/dl: 58.8% vs. 30.1%; < 70 mg/dl 70.6 vs. 49.6%. Patients with insufficiently controlled T2D (HbA1c > 54 mmol/mol) had a higher reduction in LDL-C but still were more likely to subsequent cardiovascular events. Conclusions Significant reductions in LDL-C and a high percentage of patients achieving recommended treatment targets were observed. The percentage of patients with T2D meeting recommended LDL-C targets was higher than in those without T2D. Still some patients did not achieve LDL-C levels as recommended in current guidelines. Special attention to the characteristics of these patients is required in the future to enable achievement of treatment goals and avoid adverse cardiovascular outcomes.

Implementation of the Vinehealth application, a digital health tool, into the care of patients living with brain cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13582-e13582
Author(s):  
Andrew Gvozdanovic ◽  
Riccardo Mangiapelo ◽  
Rayna Patel ◽  
Georgina Kirby ◽  
Neil Kitchen ◽  
...  
Keyword(s):  
Real World ◽  
Brain Cancer ◽  
Care Delivery ◽  
Digital Health ◽  
Patient Empowerment ◽  
Initial Step ◽  
Mixed Methodology ◽  
Structured Interviews ◽  
Strong Basis ◽  
Eortc Qlq

e13582 Background: Cancers of the brain lead to significant neurocognitive, physical and psychological morbidities. Digital technologies provide a novel platform to capture and evaluate these needs. Mobile health (mHealth) applications typically focus on one aspect of care rather than addressing the multimodal needs of the demographic of these patients. The Vinehealth application aims to address this by tracking symptoms, delivering machine learning-based personalised educational content, and facilitating reminders for medications and appointments. Where mHealth interventions traditionally lack the evidence-based approach of pharmaceuticals, this study acts as an initial step in the rigorous assessment of a new digital health tool. Methods: A mixed methodology approach was applied to evaluate the Vinehealth application as a care delivery adjunct. Patients with brain cancer were recruited from the day of their procedure ± 7 days. Over a 12-week period, we collected real-world and ePRO data via the application. We assessed qualitative feedback from mixed-methodology surveys and semi-structured interviews at onboarding and after two weeks of application use. Results: Six participants enrolled of whom four downloaded the application; four completed all interviews. One patient set up their device incorrectly and so couldn't receive the questionnaires; excluding this patient, the EQ-5D-5L and EORTC QLQ-BN20 completion rates were 100% and 83% respectively. Average scores (±SD) at onboarding and offboarding were EQ-5D-5L: 2.07±1.28 and 1.73±1.22, and QLQ-BN20: 13.33 and 22.5. In total: 212 symptoms, 174 activity, and 47 medication data points were captured, and 113 educational articles were read. Participants were generally optimistic about application use. All users stated they would recommend Vinehealth and expressed subjective improvements in care. Accessibility issues in the ePRO delivery system which impacted completion rate were identified and have subsequently been fully addressed. Conclusions: This feasibility study showed acceptable patient use, led to a subjective improvement in care, and demonstrated effective collection of real-world and validated ePRO data. This provides a strong basis to further explore the integration of the Vinehealth application into brain cancer care. This study will inform the design of a larger, more comprehensive trial continuing to evaluate improvements in care delivery through data collection, educational support and patient empowerment.

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