Evaluation of an application for the self-assessment of lifestyle behaviour in cardiac patients.

BACKGROUND: Currently, no uniform, well-validated and comprehensive lifestyle behaviour self-assessment instrument exists for patients with cardiovascular disease. PURPOSE: To evaluate the usability of a novel mobile application (LifeStyleScore) based on validated instruments for the assessment of cardiovascular risk behaviours. Secondly, the application's acceptance by healthcare professionals (HCPs) and its association with improved patient activation and lifestyle behaviour was evaluated. METHODS: In this single-centre, non-randomised observational pilot study, patients with coronary artery disease or atrial fibrillation entering cardiac rehabilitation (CR) completed the LifeStyleScore application, the Patient Activation Measure (PAM-13®), and the System Usability Scale (SUS) during the CR intake and after CR completion. A focus group interview was performed with the HCPs involved. RESULTS: We analysed 20 participants, 3 of whom were women, with a mean age of 61.9 ± 6.7 years. The LifeStyleScore application was rated with a SUS score above average (> 68) before (69.6 ± 13.4) and after CR (68.6 ± 15.1). All HCPs (n = 8) found the application usable. Patient activation did not increase significantly after CR compared with baseline (62.0 ± 8.6 versus 59.2 ± 9.5, respectively, p = 0.28) and only physical activity levels improved significantly (2.4 ± 0.7 (standardised score) at baseline, 2.8 ± 0.4 after CR, p = 0.04). CONCLUSION: The LifeStyleScore application was found to be usable for patients receiving CR. Its use did not result in increased patient activation, and of the lifestyle behaviours only physical activity levels improved. Further research is needed to evaluate how such applications can be optimally incorporated in CR programmes.

Less stick more carrot? Increasing the uptake of deposit contract financial incentives for physical activity: A randomized controlled trial.

BACKGROUND: Financial incentives are a promising tool to help people increase their physical activity, but they are expensive to provide. Deposit contracts are a type of financial incentive in which participants pledge their own money. However, low uptake is a crucial obstacle to the large-scale implementation of deposit contracts. Therefore, we investigated whether (1) matching the deposit 1:1 (doubling what is deposited) and (2) allowing for customizable deposit amounts increased the uptake and short term effectiveness of a deposit contract for physical activity. METHODS: In this randomized controlled trial, 137 healthy students (age M = 21.6 years) downloaded a smartphone app that provided them with a tailored step goal and then randomized them to one of four experimental conditions. The deposit contract required either a €10 fixed deposit or a customizable deposit with any amount between €1 and €20 upfront. Furthermore, the deposit was either not matched or 1:1 matched (doubled) with a reward provided by the experiment. During 20 intervention days, daily feedback on goal progress and incentive earnings was provided by the app. We investigated effects on the uptake (measured as agreeing to participate and paying the deposit) and effectiveness of behavioral adoption (measured as participant days goal achieved). FINDINGS: Overall, the uptake of deposit contracts was 83.2%, and participants (n = 113) achieved 14.9 out of 20 daily step goals. A binary logistic regression showed that uptake odds were 4.08 times higher when a deposit was matched (p = .010) compared to when it was not matched. Furthermore, uptake odds were 3.53 times higher when a deposit was customizable (p = .022) compared to when it was fixed. Two-way ANCOVA showed that matching (p = .752) and customization (p = .143) did not impact intervention effectiveness. However, we did find a marginally significant interaction effect of deposit matching X deposit customization (p = .063, ηp2 = 0.032). Customization decreased effectiveness when deposits were not matched (p = .033, ηp2 = 0.089), but had no effect when deposits were matched (p = .776, ηp2 = 0.001). CONCLUSIONS: We provide the first experimental evidence that both matching and customization increase the uptake of a deposit contract for physical activity. We recommend considering both matching and customization to overcome lack of uptake, with a preference for customization since matching a deposit imposes significant additional costs. However, since we found indications that customizable deposits might reduce effectiveness (when the deposits are not matched), we urge for more research on the effectiveness of customizable deposit contracts. Finally, future research should investigate which participant characteristics are predictive of deposit contract uptake and effectiveness. PRE-REGISTRATION: OSF Registries, https://osf.io/cgq48.

The prognostic value of quality of life in atrial fibrillation on patient value.

BACKGROUND: In this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed. METHODS: A cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded. RESULTS: In total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16-5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45-8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22-7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline. CONCLUSIONS: AF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.

Investigating Rewards and Deposit Contract Financial Incentives for Physical Activity Behavior Change Using a Smartphone App: Randomized Controlled Trial.

BACKGROUND: Financial incentive interventions for improving physical activity have proven to be effective but costly. Deposit contracts (in which participants pledge their own money) could be an affordable alternative. In addition, deposit contracts may have superior effects by exploiting the power of loss aversion. Previous research has often operationalized deposit contracts through loss framing a financial reward (without requiring a deposit) to mimic the feelings of loss involved in a deposit contract. OBJECTIVE: This study aimed to disentangle the effects of incurring actual losses (through self-funding a deposit contract) and loss framing. We investigated whether incentive conditions are more effective than a no-incentive control condition, whether deposit contracts have a lower uptake than financial rewards, whether deposit contracts are more effective than financial rewards, and whether loss frames are more effective than gain frames. METHODS: Healthy participants (N=126) with an average age of 22.7 (SD 2.84) years participated in a 20-day physical activity intervention. They downloaded a smartphone app that provided them with a personalized physical activity goal and either required a €10 (at the time of writing: €1=US $0.98) deposit up front (which could be lost) or provided €10 as a reward, contingent on performance. Daily feedback on incentive earnings was provided and framed as either a loss or gain. We used a 2 (incentive type: deposit or reward) × 2 (feedback frame: gain or loss) between-subjects factorial design with a no-incentive control condition. Our primary outcome was the number of days participants achieved their goals. The uptake of the intervention was a secondary outcome. RESULTS: Overall, financial incentive conditions (mean 13.10, SD 6.33 days goal achieved) had higher effectiveness than the control condition (mean 8.00, SD 5.65 days goal achieved; P=.002; ηp2=0.147). Deposit contracts had lower uptake (29/47, 62%) than rewards (50/50, 100%; P<.001; Cramer V=0.492). Furthermore, 2-way analysis of covariance showed that deposit contracts (mean 14.88, SD 6.40 days goal achieved) were not significantly more effective than rewards (mean 12.13, SD 6.17 days goal achieved; P=.17). Unexpectedly, loss frames (mean 10.50, SD 6.22 days goal achieved) were significantly less effective than gain frames (mean 14.67, SD 5.95 days goal achieved; P=.007; ηp2=0.155). CONCLUSIONS: Financial incentives help increase physical activity, but deposit contracts were not more effective than rewards. Although self-funded deposit contracts can be offered at low cost, low uptake is an important obstacle to large-scale implementation. Unexpectedly, loss framing was less effective than gain framing. Therefore, we urge further research on their boundary conditions before using loss-framed incentives in practice. Because of limited statistical power regarding some research questions, the results of this study should be interpreted with caution, and future work should be done to confirm these findings. TRIAL REGISTRATION: Open Science Framework Registries osf.io/34ygt; https://osf.io/34ygt.

Cost-effectiveness of Cardiac Telerehabilitation With Relapse Prevention for the Treatment of Patients With Coronary Artery Disease in the Netherlands.

Importance: Cardiac telerehabilitation (CTR) has been found to be a safe and beneficial alternative to traditional center-based cardiac rehabilitation (CR) and might be associated with higher participation rates by reducing barriers to CR use. However, implementation of CTR interventions remains low, which may be owing to a lack of cost-effectiveness analyses of data from large-scale randomized clinical trials. Objective: To assess the cost-effectiveness of CTR with relapse prevention compared with center-based CR among patients with coronary artery disease. Design, Setting, and Participants: This economic evaluation performed a cost-utility analysis of data from the SmartCare-CAD (Effects of Cardiac Telerehabilitation in Patients With Coronary Artery Disease Using a Personalized Patient-Centred ICT Platform) randomized clinical trial. The cost-effectiveness and utility of 3 months of cardiac telerehabilitation followed by 9 months of relapse prevention were compared with the cost-effectiveness of traditional center-based cardiac rehabilitation. The analysis included 300 patients with stable coronary artery disease who received care at a CR center serving 2 general hospitals in the Netherlands between May 23, 2016, and July 26, 2018. All patients were entering phase 2 of outpatient CR and were followed up for 1 year (until August 14, 2019). Data were analyzed from September 21, 2020, to September 24, 2021. Intervention: After baseline measurements were obtained, participants were randomly assigned on a 1:1 ratio to receive CTR (intervention group) or center-based CR (control group) using computerized block randomization. After 6 supervised center-based training sessions, patients in the intervention group continued training at home using a heart rate monitor and accelerometer. Patients uploaded heart rate and physical activity data and discussed their progress during a weekly video consultation with their physical therapist. After 3 months, weekly coaching was concluded, and on-demand coaching was initiated for relapse prevention; patients were instructed to continue using their wearable sensors and were contacted in cases of nonadherence to the intervention or reduced exercise or physical activity volumes. Main Outcomes and Measures: Quality-adjusted life-years were assessed using the EuroQol 5-Dimension 5-Level survey (EQ-5D-5L) and the EuroQol Visual Analogue Scale (EQ-VAS), and cardiac-associated health care costs and non-health care costs were measured by health care consumption, productivity, and informal care questionnaires (the Medical Consumption Questionnaire, the Productivity Cost Questionnaire, and the Valuation of Informal Care Questionnaire) designed by the Institute for Medical Technology Assessment. Costs were converted to 2020 price levels (in euros) using the Dutch consumer price index (to convert to US dollars, euro values were multiplied by 1.142, which was the mean exchange rate in 2020). Results: Among 300 patients (266 men [88.7%]), the mean (SD) age was 60.7 (9.5) years. The quality of life among patients receiving CTR vs center-based CR was comparable during the study according to the results of both utility measures (mean difference on EQ-5D-5L: -0.004; P = .82; mean difference on EQ-VAS: -0.001; P = .92). Intervention costs were significantly higher for CTR (mean [SE], €224 [€4] [$256 ($4)]) compared with center-based CR (mean [SE], €156 [€5] [$178 ($6)]; P < .001); however, no difference in overall cardiac health care costs was observed between CTR (mean [SE], €4787 [€503] [$5467 ($574)] and center-based CR (mean [SE], €5507 [€659] [$6289 ($753)]; P = .36). From a societal perspective, CTR was associated with lower costs compared with center-based CR (mean [SE], €20 495 [€ 2751] [$23 405 ($3142)] vs €24 381 [€3613] [$27 843 ($4126)], respectively), although this difference was not statistically significant (-€3887 [-$4439]; P = .34). Conclusions and Relevance: In this economic evaluation, a CTR intervention with relapse prevention was likely to be cost-effective compared with center-based CR, suggesting that CTR maybe used as an alternative intervention for the treatment of patients with coronary artery disease. These results add to the evidence base in favor of CTR and may increase the implementation of CTR interventions in clinical practice.

Effects of cardiac telerehabilitation in patients with coronary artery disease using a personalised patient-centred web application: protocol for the SmartCare-CAD randomised controlled trial.

BACKGROUND: Cardiac rehabilitation has beneficial effects on morbidity and mortality in patients with coronary artery disease, but is vastly underutilised and short-term improvements are often not sustained. Telerehabilitation has the potential to overcome these barriers, but its superiority has not been convincingly demonstrated yet. This may be due to insufficient focus on behavioural change and development of patients' self-management skills. Moreover, potentially beneficial communication methods, such as internet and video consultation, are rarely used. We hypothesise that, when compared to centre-based cardiac rehabilitation, cardiac telerehabilitation using evidence-based behavioural change strategies, modern communication methods and on-demand coaching will result in improved self-management skills and sustainable behavioural change, which translates to higher physical activity levels in a cost-effective way. METHODS: This randomised controlled trial compares cardiac telerehabilitation with centre-based cardiac rehabilitation in patients with coronary artery disease. We randomise 300 patients entering cardiac rehabilitation to centre-based cardiac rehabilitation (control group) or cardiac telerehabilitation (intervention group). The core component of the intervention is a patient-centred web application, which enables patients to adjust rehabilitation goals, inspect training and physical activity data, share data with other caregivers and to use video consultation. After six supervised training sessions, the intervention group continues exercise training at home, wearing an accelerometer and heart rate monitor. In addition, physical activity levels are assessed by the accelerometer for four days per week. Patients upload training and physical activity data weekly and receive feedback through video consultation once a week. After completion of the rehabilitation programme, on-demand coaching is performed when training adherence or physical activity levels decline with 50% or more. The primary outcome measure is physical activity level, assessed at baseline, three months and twelve months, and is calculated from accelerometer and heart rate data. Secondary outcome measures include physical fitness, quality of life, anxiety and depression, patient empowerment, patient satisfaction and cost-effectiveness. DISCUSSION: This study is one of the first studies evaluating effects and costs of a cardiac telerehabilitation intervention comprising a combination of modern technology and evidence-based behavioural change strategies including relapse prevention. We hypothesise that this intervention has superior effects on exercise behaviour without exceeding the costs of a traditional centre-based intervention. TRIAL REGISTRATION: Netherlands Trial Register NTR5156 . Registered 22 April 2015.

Effects and costs of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: The FIT@Home study.

BACKGROUND: Physical training has beneficial effects on exercise capacity, quality of life and mortality in patients after a cardiac event or intervention and is therefore a core component of cardiac rehabilitation. However, cardiac rehabilitation uptake is low and effects tend to decrease after the initial rehabilitation period. Home-based training has the potential to increase cardiac rehabilitation uptake, and was shown to be safe and effective in improving short-term exercise capacity. Long-term effects on physical fitness and activity, however, are disappointing. Therefore, we propose a novel strategy using telemonitoring guidance based on objective training data acquired during exercise at home. In this way, we aim to improve self-management skills like self-efficacy and action planning for independent exercise and, consequently, improve long-term effectiveness with respect to physical fitness and physical activity. In addition, we aim to compare costs of this strategy with centre-based cardiac rehabilitation. METHODS/DESIGN: This randomized controlled trial compares a 12-week telemonitoring guided home-based training program with a regular, 12-week centre-based training program of equal duration and training intensity in low to moderate risk patients entering cardiac rehabilitation after an acute coronary syndrome or cardiac intervention. The home-based group receives three supervised training sessions before they commence training with a heart rate monitor in their home environment. Participants are instructed to train at 70-85% of their maximal heart rate for 45-60 minutes, twice a week. Patients receive individual coaching by telephone once a week, based on measured heart rate data that are shared through the internet. Primary endpoints are physical fitness and physical activity, assessed at baseline, after 12 weeks and after one year. Physical fitness is expressed as peak oxygen uptake, assessed by symptom limited exercise testing with gas exchange analysis; physical activity is expressed as physical activity energy expenditure, assessed by tri-axial accelerometry and heart rate measurements. Secondary endpoints are training adherence, quality of life, patient satisfaction and cost-effectiveness. DISCUSSION: This study will increase insight in long-term effectiveness and costs of home-based cardiac rehabilitation with telemonitoring guidance. This strategy is in line with the trend to shift non-complex healthcare services towards patients' home environments. TRIAL REGISTRATION: Dutch Trial Register: NTR3780. Clinicaltrials.gov register: NCT01732419.

[Cardiac rehabilitation deserves higher priority]. / Hartrevalidatie verdient hogere prioriteit.

A report from the Dutch Health Inspectorate states that both the participation rates and the quality of Dutch cardiac rehabilitation programs are inadequate. Therefore health care professionals, hospitals and health care insurers should give cardiac rehabilitation a higher priority. An elementary requirement to increase cardiac rehabilitation uptake is the availability of sufficient financial resources. In addition, more research is needed to unravel the causal mechanisms of non-attendance in subgroups with low cardiac rehabilitation uptake rates, such as women and elderly patients. Given the uncertainty about a realistic target value, evaluating cardiac rehabilitation centres on cardiac rehabilitation uptake rate does not seem meaningful at this stage.

Revision of the Dutch clinical algorithm for assessing patient needs in cardiac rehabilitation based on identified implementation problems.

BACKGROUND: Despite all available evidence of its effectiveness, cardiac rehabilitation and secondary prevention (CRSP) is still insufficiently implemented in current clinical practice. Based on an analysis of implementation problems, recently the Dutch clinical algorithm for the assessment of patient's CRSP needs was revised. The purpose of this paper is to describe the revision process and its results to improve CRSP guideline implementation. METHODS: The National Institute for Health and Clinical Excellence (NICE) guidelines manual for conducting guideline revisions was followed. Information on the use of the algorithm in practice was collected from electronic medical records and by conducting semi-structured interviews. Next, an expert advisory group identified the problems for use in daily practice and defined the scope for the revision. A multidisciplinary guideline development group subsequently wrote the revised algorithm. RESULTS: A large variation in assessed patient needs was observed between CRSP clinics. Assessment based on clinical judgement was found to be a source of practice variation and is therefore avoided in the revised algorithm. It was decided to add assessment instruments for anxiety and depression, cardiovascular risk factors, stress, attitude of partner and lifestyle parameters. CONCLUSION: The Dutch clinical algorithm for assessing patient needs for CRSP was revised using a combination of patient data from routine practice, knowledge from academic experts and experience from field experts. The revised algorithm is a practical tool consisting of assessment instruments to improve CRSP guideline adherence in the Netherlands. This algorithm may also be useful for other Western countries to organize their CRSP needs assessment procedure.

Assessment of the effects of physical training in patients with chronic heart failure: the utility of effort-independent exercise variables.

Traditionally, the effects of physical training in patients with chronic heart failure (CHF) are evaluated by changes in peak oxygen uptake (peak VO(2)). The assessment of peak VO(2), however, is highly dependent on the patients' motivation. The aim of the present study was to evaluate the clinical utility of effort-independent exercise variables for detecting training effects in CHF patients. In a prospective controlled trial, patients with stable CHF were allocated to an intervention group (N = 30), performing a 12-week combined cycle interval and muscle resistance training program, or a control group (N = 18) that was matched for age, gender, body composition and left ventricular ejection fraction. The following effort-independent exercise variables were evaluated: the ventilatory anaerobic threshold (VAT), oxygen uptake efficiency slope (OUES), the V(E)/VCO(2) slope and the time constant of VO(2) kinetics during recovery from submaximal constant-load exercise (tau-rec). In addition to post-training increases in peak VO(2) and peak V(E), the intervention group showed significant within and between-group improvements in VAT, OUES and tau-rec. There were no significant differences between relative improvements of the effort-independent exercise variables in the intervention group. In contrast with VAT, which could not be determined in 9% of the patients, OUES and tau-rec were determined successfully in all patients. Therefore, we conclude that OUES and tau-rec are useful in clinical practice for the assessment of training effects in CHF patients, especially in cases of poor subject effort during symptom-limited exercise testing or when patients are unable to reach a maximal exercise level.

Evaluation of two methods for continuous cardiac output assessment during exercise in chronic heart failure patients.

The purpose of this study was to evaluate the accuracy of two techniques for the continuous assessment of cardiac output in patients with chronic heart failure (CHF): a radial artery pulse contour analysis method that uses an indicator dilution method for calibration (LiDCO) and an impedance cardiography technique (Physioflow), using the Fick method as a reference. Ten male CHF patients (New York Heart Association class II-III) were included. At rest, cardiac output values obtained by LiDCO and Physioflow were compared with those of the direct Fick method. During exercise, the continuous Fick method was used as a reference. Exercise, performed on a cycle ergometer in upright position, consisted of two constant-load tests at 30% and 80% of the ventilatory threshold and a symptom-limited maximal test. Both at rest and during exercise LiDCO showed good agreement with reference values [bias +/- limits of agreement (LOA), -1% +/- 28% and 2% +/- 28%, respectively]. In contrast, Physioflow overestimated reference values both at rest and during exercise (bias +/- LOA, 48% +/- 60% and 48% +/- 52%, respectively). Exercise-related within-patient changes of cardiac output, expressed as a percent change, showed for both techniques clinically acceptable agreement with reference values (bias +/- LOA: 2% +/- 26% for LiDCO, and -2% +/- 36% for Physioflow, respectively). In conclusion, although the limits of agreement with the Fick method are pretty broad, LiDCO provides accurate measurements of cardiac output during rest and exercise in CHF patients. Although Physioflow overestimates cardiac output, this method may still be useful to estimate relative changes during exercise.