Gamification-augmented home-based exercise for peripheral artery disease: Rationale and design of the GAMEPAD Study.

BACKGROUND: Supervised exercise therapy improves walking performance, functional capacity, and quality of life in patients with peripheral artery disease (PAD). However, few patients with PAD are enrolled in supervised exercise programs, and there are a number of logistical and financial barriers to their participation. A home-based walking intervention is likely to be more accessible to patients with PAD, but no fully home-based walking program has demonstrated efficacy. Concepts from behavioral economics have been used to design scalable interventions that increase daily physical activity in patients with atherosclerotic vascular disease, but whether a similar program would be effective in patients with PAD is uncertain. STUDY DESIGN AND OBJECTIVES: GAMEPAD (NCT04536012) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of a gamification strategy informed by concepts from behavioral economics to increase daily physical activity in patients with PAD who are seen in cardiology and vascular surgery clinics affiliated with the University of Pennsylvania Health System. Patients are contacted by email or text message, and complete enrollment and informed consent on the Penn Way to Health online platform. A GAMEPAD substudy will evaluate the effectiveness of opt-in versus opt-out framing when approaching patients for study participation. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 33%-50%, and are randomized 1:1 to the gamification or control arms. Interventions continue for 16 weeks, including a 4-week period during which goal step count is gradually increased in the gamification arm, with follow-up for an additional 8 weeks to evaluate the durability of behavior change. The trial has met its enrollment goal of 102 participants, with a primary endpoint of change from baseline in daily steps over the 16-week intervention period. Key secondary endpoints include change from baseline in daily steps over the 8-week postintervention follow-up period and changes in patient-reported measures of PAD symptoms and quality of life over the intervention and follow-up periods. CONCLUSIONS: GAMEPAD is a virtual, pragmatic randomized clinical trial of a novel, fully home-based walking intervention informed by concepts from behavioral economics to increase physical activity and PAD-specific quality of life in patients with PAD. Its results will have important implications for the application of behavioral economic concepts to scalable home-based strategies to promote physical activity in patients with PAD and other disease processes where physical activity is limited by exertional symptoms. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov; NCT04536012.

Patient Characteristics Associated With Telemedicine Access for Primary and Specialty Ambulatory Care During the COVID-19 Pandemic.

Importance: The coronavirus disease 2019 (COVID-19) pandemic has required a shift in health care delivery platforms, necessitating a new reliance on telemedicine. Objective: To evaluate whether inequities are present in telemedicine use and video visit use for telemedicine visits during the COVID-19 pandemic. Design, Setting, and Participants: In this cohort study, a retrospective medical record review was conducted from March 16 to May 11, 2020, of all patients scheduled for telemedicine visits in primary care and specialty ambulatory clinics at a large academic health system. Age, race/ethnicity, sex, language, median household income, and insurance type were all identified from the electronic medical record. Main Outcomes and Measures: A successfully completed telemedicine visit and video (vs telephone) visit for a telemedicine encounter. Multivariable models were used to assess the association between sociodemographic factors, including sex, race/ethnicity, socioeconomic status, and language, and the use of telemedicine visits, as well as video use specifically. Results: A total of 148 402 unique patients (86 055 women [58.0%]; mean [SD] age, 56.5 [17.7] years) had scheduled telemedicine visits during the study period; 80 780 patients (54.4%) completed visits. Of 78 539 patients with completed visits in which visit modality was specified, 35 824 (45.6%) were conducted via video, whereas 24 025 (56.9%) had a telephone visit. In multivariable models, older age (adjusted odds ratio [aOR], 0.85 [95% CI, 0.83-0.88] for those aged 55-64 years; aOR, 0.75 [95% CI, 0.72-0.78] for those aged 65-74 years; aOR, 0.67 [95% CI, 0.64-0.70] for those aged ≥75 years), Asian race (aOR, 0.69 [95% CI, 0.66-0.73]), non-English language as the patient's preferred language (aOR, 0.84 [95% CI, 0.78-0.90]), and Medicaid insurance (aOR, 0.93 [95% CI, 0.89-0.97]) were independently associated with fewer completed telemedicine visits. Older age (aOR, 0.79 [95% CI, 0.76-0.82] for those aged 55-64 years; aOR, 0.78 [95% CI, 0.74-0.83] for those aged 65-74 years; aOR, 0.49 [95% CI, 0.46-0.53] for those aged ≥75 years), female sex (aOR, 0.92 [95% CI, 0.90-0.95]), Black race (aOR, 0.65 [95% CI, 0.62-0.68]), Latinx ethnicity (aOR, 0.90 [95% CI, 0.83-0.97]), and lower household income (aOR, 0.57 [95% CI, 0.54-0.60] for income <$50 000; aOR, 0.89 [95% CI, 0.85-0.92], for $50 000-$100 000) were associated with less video use for telemedicine visits. These results were similar across medical specialties. Conclusions and Relevance: In this cohort study of patients scheduled for primary care and medical specialty ambulatory telemedicine visits at a large academic health system during the early phase of the COVID-19 pandemic, older patients, Asian patients, and non-English-speaking patients had lower rates of telemedicine use, while older patients, female patients, Black, Latinx, and poorer patients had less video use. Inequities in accessing telemedicine care are present, which warrant further attention.

Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial.

BACKGROUND: Regular physical activity reduces the risk of cardiovascular events, but most ischemic heart disease (IHD) patients do not obtain enough. METHODS AND RESULTS: ACTIVE REWARD (A Clinical Trial Investigating Effects of a Randomized Evaluation of Wearable Activity Trackers with Financial Rewards) was a 24-week home-based, remotely monitored, randomized trial with a 16-week intervention (8-week ramp-up incentive phase and 8-week maintenance incentive phase) and an 8-week follow-up. Patients used wearable devices to track step counts and establish a baseline. Patients in control received no other interventions. Patients in the incentive arm received personalized step goals and daily feedback for all 24 weeks. In the ramp-up incentive phase, daily step goals increased weekly by 15% from baseline with a maximum of 10 000 steps and then remained fixed. Each week, $14 was allocated to a virtual account; $2 could be lost per day for not achieving step goals. The primary outcome was change in mean daily steps from baseline to the maintenance incentive phase. Ischemic heart disease patients had a mean (SD) age of 60 (11) years and 70% were male. Compared with control, patients in the incentive arm had a significantly greater increase in mean daily steps from baseline during ramp-up (1388 versus 385; adjusted difference, 1061 [95% confidence interval, 386-1736]; P<0.01), maintenance (1501 versus 264; adjusted difference, 1368 [95% confidence interval, 571-2164]; P<0.001), and follow-up (1066 versus 92; adjusted difference, 1154 [95% confidence interval, 282-2027]; P<0.01). CONCLUSIONS: Loss-framed financial incentives with personalized goal setting significantly increased physical activity among ischemic heart disease patients using wearable devices during the 16-week intervention, and effects were sustained during the 8-week follow-up. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02531022.

Systemic Inflammation Associated With World Trade Center Dust Exposures and Airway Abnormalities in the Local Community.

BACKGROUND: Destruction of the World Trade Center (WTC) towers on September 11, 2001, released massive dust, gas, and fumes with environmental exposures for community members. Many community members have lower respiratory symptoms (LRSs) that began after September 11, 2001, and remain persistent. We evaluated whether systemic inflammation measured by C-reactive protein was associated with WTC dust exposures, persistent LRS, and lung function. METHODS: Community members self-referred for the treatment of symptoms related to September 11, 2001. C-reactive protein and lung function measurements, including spirometry and forced oscillation tests (impulse oscillometry system), were included as routine analyses in patients (2007 to 2012). RESULTS: Increased C-reactive protein levels were associated with the type of WTC dust exposure, LRS, reduced spirometry, and increased forced oscillation measurements (n = 724). CONCLUSIONS: Ongoing systemic inflammation measured years after the event was associated with WTC dust exposures, persistent LRS, and abnormal lung function in a community cohort. These findings have implications for treatment and surveillance.

Cardiac imaging in the geriatric population: what do we think we know, and what do we need to learn?

Cardiac imaging plays an important role in coronary artery disease (CAD), congestive heart failure (HF) and valvular heart disease (VHD) in the elderly. Imaging defines the structure and function of the cardiac system, refining the understanding of patients' anatomy and physiology and informing a host of clinical care decisions, including prognosis. Yet there is a paucity of evidence to guide the rational use of many imaging modalities in patients of advanced age, a population with considerable clinical heterogeneity, high prevalence and burden of cardiovascular disease (CVD) and atypical presentations of CVD. This paper discusses important considerations for cardiac imaging for older adults, particularly in regard to CAD, VHD and HF, and then presents domains for future research to produce data that would inform clinical care guidelines, appropriate use criteria and imaging lab protocols to address the unique needs of the fast-growing elderly population.

Appropriateness of statins in patients aged ≥80 years and comparison to other age groups.

In patients aged ≥80 years without previous coronary artery disease, peripheral vascular disease, or cerebrovascular disease, no evidence has shown a benefit from statin therapy. We examined the prevalence of statin use in patients aged ≥80 years for the indication of primary prevention. We reviewed the comprehensive electronic health records at the Geisinger Health System in Pennsylvania for all patients aged >55 years with ≥1 primary care encounter from January 24, 2004 and December 31, 2009. The records were scrutinized for the use of a statin, active medical diagnoses, and laboratory values. Patients without a previous diagnosis of coronary artery disease, peripheral vascular disease, or cerebrovascular disease were considered to have a primary prevention indication for statin therapy. The prevalence of statin use was examined, and a multivariate analysis was conducted to determine the predictors of use. A total of 89,086 patients were included in the analysis, with 22,646 patients aged ≥80 years. Of all the patients, 26% were prescribed a statin, of whom, 71% (n = 16,687) received it for primary prevention. Of the 14,604 patients aged ≥80 years with a primary prevention indication, 3,145 (22%) received a statin. A plot of 5-year age cohorts from 55 to >90 years demonstrated an n-shaped relation between age and statin use for primary prevention (18%, 23%, 27%, 29%, 28%, 26%, 21%, and 12%, p <0.001). Compared to patients aged <65 years, the ratio of statin prescription for secondary to primary prevention was 31% lower in patients aged ≥80 years (1.3 vs 1.9). Those aged ≥80 years with a primary prevention indication had, with treatment, a mean low-density lipoprotein level of 84 ± 26 mg/dl. In conclusion, many patients aged ≥80 years receive statin therapy for primary prevention and are treated to aggressive low-density lipoprotein levels. Because the efficacy is uncertain and the potential adverse effects are many, we urgently need to define the cost, benefit, and risk of statin use in the very elderly.

Sex and race are associated with the absence of epicardial coronary artery obstructive disease at angiography in patients with acute coronary syndromes.

BACKGROUND: A substantial minority of patients with acute coronary syndromes (ACS) do not have a diameter stenosis of any major epicardial coronary artery on angiography ("no obstruction at angiography") of > or = 50%. We examined the frequency of this finding and its relationship to race and sex. HYPOTHESIS: Among patients with myocardial infarction, younger age, female sex and non-white race are associated with the absence of obstructive coronary artery disease at angiography. METHODS: We reviewed the results of all angiograms performed from May 19, 2006 to September 29, 2006 at 1 private (n = 793) and 1 public (n = 578) urban academic medical center. Charts were reviewed for indication and results of angiography, and for demographics. RESULTS: The cohort included 518 patients with ACS. There was no obstruction at angiography in 106 patients (21%), including 48 (18%) of 258 patients with myocardial infarction. Women were more likely to have no obstruction at angiography than men, both in the overall cohort (55/170 women [32%] vs 51/348 men [15%], P < 0.001) and in the subset with MI (29/90 women [32%] vs 19/168 men [11%], P < 0.001). Black patients were more likely to have no obstruction at angiography relative to any other subgroup (24/66 [36%] vs 41/229 [18%] Whites, 31/150 [21%] Hispanics, and 5/58 [9%] Asians, P = 0.001). Among women, Black patients more frequently had no obstruction at angiography compared with other ethnic groups (16/27 [59%] vs 17/59 [29%] Whites, 17/60 [28%] Hispanics, and 3/19 [6%] Asians, P = 0.001). CONCLUSIONS: A high proportion of a multiethnic sample of patients with ACS were found to have no stenosis > or = 50% in diameter at coronary angiography. This was particularly common among women and Black patients.