Improving diabetic patients’ adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice—IMPACT Study)—a cluster randomized controlled effectiveness trial

Abstract

Background Despite nationwide improvements in cardiovascular disease (CVD) mortality and morbidity, CVD deaths in adults with type 2 diabetes (T2DM) are 2–4 times higher than among those without T2DM. A key contributor to these poor health outcomes is medication non-adherence. Twenty-one to 42% of T2DM patients do not take blood sugar, blood pressure (BP), or statin medications as prescribed. Interventions that foster and reinforce patient-centered communication show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in real-life primary care settings. Methods This pragmatic cluster-randomized trial randomizes 17 teams in 12 Federally Qualified Healthcare Centers (FQHCs) to two experimental groups: intervention (group 1): Office-Gap + Texting vs. control (group 2): Texting only. Office-GAP (Office-Guidelines Applied to Practice) is a patient activation intervention to improve communication and patient-provider partnerships through brief patient and provider training in shared decision-making (SDM) and use of a guideline-based checklist. The texting intervention (Way2Health) is a cell phone messaging service that informs and encourages patients to adhere to goals, adhere to medication use and improve communication. After recruitment, patients in groups 1 and 2 will both attend (1) one scheduled group visit, (90–120 min) conducted by trained research assistants, and (2) follow-up visits with their providers after group visit at 0–1, 3, 6, 9, and 12 months. Data will be collected over 12-month intervention period. Our primary outcome is medication adherence measured using eCAP electronic monitoring and self-report. Secondary outcomes are (a) diabetes-specific 5-year CVD risk as measured with the UK Prospective Diabetes Study (UKPDS) Engine score, (b) provider engagement as measured by the CollaboRATE Shared-Decision Making measure, and (c) patient activation measures (PAM). Discussion This study will provide a rigorous pragmatic evaluation of the effectiveness of combined mHealth, and patient activation interventions compared to mHealth alone, targeting patients and healthcare providers in safety net health centers, in improving medication adherence and decreasing CVD risk. Given that 20–50% of adults with chronic illness demonstrate medication non-adherence, increasing adherence is essential to improve CVD outcomes as well as healthcare cost savings. Trial registration The ClinicalTrials.gov registration number is NCT04874116.

What is meant by ‘integrated personalized diabetes management’: A view into the future and what success should look like

“…All this technology generates data that might be useful in managing diabetes and could potentially help with diet and exercise, symptom management and coordinating self‐care 82–84 . Several smartphone apps use these data to support glucose monitoring and lifestyle management such as diet, exercise, sleep and therapy adherence 85,86 . Regardless of the methodological limitations mentioned in the literature, most of the reviewed smartphone apps have shown a positive effect on outcomes, including glycated haemoglobin (HbA1c) levels and hypoglycaemia rates 87–89 …”

“…[82][83][84] Several smartphone apps use these data to support glucose monitoring and lifestyle management such as diet, exercise, sleep and therapy adherence. 85,86 Regardless of the methodological limitations mentioned in the literature, most of the reviewed smartphone apps have shown a positive effect on outcomes, including glycated haemoglobin (HbA1c) levels and hypoglycaemia rates. [87][88][89] F I G U R E 2 Classification and stratification of patient with diabetes mellitus according to risk level, complexity and characterization of care provision.…”

Effects of a medication adherence app among medically underserved adults with chronic illness: a randomized controlled trial

“…If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright use and using hands-on exercises, as well as prescribing an app have all been suggested to increase patient success (Chan et al, 2017). Keeping staff informed and trained to participate in app interventions can be challenging due to high staff turnover (Olomu et al, 2022). It has been suggested that implementation and monitoring of apps in FQHC primary care settings should be assigned to individuals other than physicians or nurse practitioners (Mares et al, 2016).…”

Glucocentric and cardiocentric approaches to achieving type 2 diabetes compensation

“…У фармакотерапії ЦД2 спостерігається зміщення акцентів у бік комбінації цукрознижувальних препаратів з різним механізмом дії [8,9]. Доведена й обґрунтована необхідність широкого використання комбінованої терапії для ефективного контролю глікемії.…”