Introduction: Cardiovascular disease is the most common cause of death among people with non-alcoholic fatty liver disease (NAFLD) and lifestyle changes can improve health outcomes. A NAFLD digital intervention was designed and here we report retention, engagement and satisfaction results in addition to the program's potential clinical impact on markers of liver- and cardiometabolic health. Hypothesis: We assessed the hypothesis that a digital intervention is feasible for individuals with metabolic derangements and NAFLD to improve cardiometabolic health. Methods: A prospective, open label, single arm, 12 week long study was conducted in Iceland.The intervention was delivered through the Sidekick app, with focus on disease education, low carbohydrate diet, increasing activity levels, reducing stress and healthy lifestyle coaching. Individuals with either BMI>30, metabolic syndrome or type 2 diabetes were screened for NAFLD with a FibroScan assessment. Other potential reasons for liver steatosis were excluded. Following recruitment and collection of demographic data, anthropometric and clinical measurements, MRI-PDFF for liver fat content, dual-energy X-ray absorptiometry for body composition and blood tests, were carried out at baseline and after 12 weeks. Primary outcomes were engagement and retention as measured in-app, and user satisfaction (mHealth App Usability Questionnaire); secondary outcomes were changes in weight, liver fat content and other cardiovascular risk factors. Results: In total, 38 individuals were included in the study and 34 (89%) completed the program (defined as being active 9/12 weeks). The median age was 59.5 [IQR 46.0,69.0] years and 23 (60.5%) were females. The median number of active days was 81 [IQR 45.8, 84.0] and the median user satisfaction score was 6.3 out of 7. The mean weight loss was 3.5 kg (SD=3.7) (p<0.001) with 5.0% (SD=7.0) reduction in fat mass (p<0.001), the average relative liver fat reduction was 19.3% (SD=23.9) (p<0.001). Systolic blood pressure reduced by 6.0 mmHg on average (SD=13.5) (p=0.009), diastolic blood pressure by 1.2 mmHg (SD=7.7) (p=0.357), triglyceride levels by 0.3 mmol/L (SD=0.6) (p=0.003) and waist circumference by 4.1 cm (SD=5.2) (p<0.001). In addition, participants who were active in-app at least 5 days per week on average achieved 3.8 kg (SD=3.7) (p<0.001) more weight loss and 19.3% (SD=23.9) (p=0.011) higher reduction in absolute liver fat percentage, compared to those who used the app less. Conclusion: This study suggests that a holistic digital intervention may improve liver-specific and cardiometabolic health in individuals with NAFLD, as indicated by the reduction in liver fat, systolic blood pressure and improvements in body composition. Together with the excellent program engagement, completion and satisfaction, this approach could provide a new tool to improve health outcomes in NAFLD.
Introduction: Patients with peripheral artery disease (PAD) are at increased risk for adverse cardiovascular and limb events and impaired quality of life. Lifestyle factors, such as patient physical activity levels and dietary habits, are known risk factors. Limited data is available on the feasibility and efficacy of tailored PAD digital therapeutic programs, focused on improving lifestyle (e.g. physical activity levels, dietary habits, sleep, stress, energy levels) and medication adherence. Hypothesis: We assessed the hypothesis that a digital therapeutic program is feasible among elderly patients with PAD. Methods: Patients were recruited from two vascular surgery specialty clinics in Sweden. Fourteen patients signed informed consent forms and started a four-week intervention based on the first weeks of the SK-111 digital program (Sidekick Health). Questionnaires were administered at baseline and at the end of the intervention. Data on in-app activity was collected throughout the intervention. Results: Out of the 14 patients (8 men, 6 women) who started the intervention, 11 stayed active within the platform from week 1 through 4. The 11 active participants performed a median of 7.1 activities in the app/day (IQR=3.4-12.9) and logged a median number of 4500 steps/day (IQR=2700-6455). The amount of physical activity logged/day went up from a mean of 21 (SD=39) min/day to 33 (SD=54) min/day from week 1 to week 4 (p=0.201). Seven participants (median age=72, IQR=69-73 years) answered both pre and post questionnaires. No changes were observed from pre to post intervention for either the walking distance domain of the Walking Impairment Questionnaire: 22.7 (SD=0.1) and 24.3 (SD=0.1), (p=0.499) or the Vascular Quality of Life Questionnaire sum score: 15.4 (SD=3.2) and 15.6 (SD=3.4), (p=0.864). For the pre-post medication adherence question (“During the last week, did you ever forget to take your PAD medication?” Rated from 0-10), ratings went down from 2.0 (SD=3.6) before to 0.1 (SD=0.4) after intervention (p=0.048). A post-program question asking whether using the platform helped them remember to take their medication, 5/7 (71%) patients considered it helpful. When asked how likely patients would be to recommend the PSP to others, the average score was 83/100. Conclusions: The findings from this feasibility study indicate that a PAD digital therapeutic program is feasible for elderly patients with PAD. A multicenter RCT is currently ongoing, where the clinical effectiveness of the full SK-111 will be further explored in this patient group.
Hospital-based supervised exercise (SEP) is a guideline-recommended intervention for patients with intermittent claudication (IC). However, due to the limited availability of SEP, home-based structured exercise programs (HSEP) have become increasingly popular alongside the “go home and walk” advice. We evaluated the cost-effectiveness of walk advice (WA) with Nordic pole walking vs. SEP combined with WA or HSEP combined with WA. We used data from the SUNFIT RCT (NCT02341716) to measure quality-adjusted life-years (QALYs) over a 12-month follow-up, and economic costs were obtained from a hospital cost-per-patient accounting system. Incremental cost-effectiveness ratios (ICERs) were calculated, and uncertainty was assessed using nonparametric bootstrapping. The average health-care-cost per patient was similar in the WA (EUR 1781, n = 51) and HSEP (EUR 1820, n = 48) groups but higher in the SEP group (EUR 4619, n = 50, p-value < 0.01). Mean QALYs per patient during the follow-up were similar with no statistically significant differences. The findings do not support SEP as a cost-effective treatment for IC, as it incurred significantly higher costs without providing additional health improvements over WA with or without HSEP during the one-year observation period. The analysis also suggested that HSEP may be cost-effective compared to WA, but only with a 64% probability.
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