Proof-of-concept trial results of the HeartMan mobile personal health system for self-management in congestive heart failure.

This study tested the effectiveness of HeartMan-a mobile personal health system offering decisional support for management of congestive heart failure (CHF)-on health-related quality of life (HRQoL), self-management, exercise capacity, illness perception, mental and sexual health. A randomized controlled proof-of-concept trial (1:2 ratio of control:intervention) was set up with ambulatory CHF patients in stable condition in Belgium and Italy. Data were collected by means of a 6-min walking test and a number of standardized questionnaire instruments. A total of 56 (34 intervention and 22 control group) participants completed the study (77% male; mean age 63 years, sd 10.5). All depression and anxiety dimensions decreased in the intervention group (p < 0.001), while the need for sexual counselling decreased in the control group (p < 0.05). Although the group differences were not significant, self-care increased (p < 0.05), and sexual problems decreased (p < 0.05) in the intervention group only. No significant intervention effects were observed for HRQoL, self-care confidence, illness perception and exercise capacity. Overall, results of this proof-of-concept trial suggest that the HeartMan personal health system significantly improved mental and sexual health and self-care behaviour in CHF patients. These observations were in contrast to the lack of intervention effects on HRQoL, illness perception and exercise capacity.

Sexual counselling in patients with heart failure: Perceptions and current practice by healthcare providers in Flanders.

BACKGROUND: Although heart failure (HF) patients often consider sexual activity as an essential aspect of their quality of life (QoL) and are usually uncertain if it is safe to perform sexual activity, this topic is overall poorly addressed in clinical practice. AIMS: The aim of this study was to explore the perceptions and practices of Flemish caregivers. METHODS: Healthcare providers were recruited through convenience sampling and filled in an adapted version of the UNITE Sexual Counselling Instrument. Several relevant network structures in Flanders were used to distribute the questionnaires-online as well as on paper-to healthcare workers being involved in the care to HF patients. RESULTS: Results of 180 participants indicated that 51.5% of the healthcare providers have never provided sexual counselling in HF patients. Being male, having a masters' degree, having more than 10 years of experience in cardiovascular disease, working in an ambulatory care department and having more positive attitudes were independently associated with a higher provision of sexual counselling in practice. CONCLUSION: Although healthcare providers perceive it as their responsibility to discuss patients' sexual concerns, these issues are not often addressed in daily practice. Increasing knowledge in healthcare providers and specific practical training in providing information on sexual activity in HF patients are recommended. Further studies are needed to investigate how sexual counselling can be provided in agreement with HF patients' expectations and needs.

Sexual Activity in Heart Failure Patients: Information Needs and Association with Health-Related Quality of Life.

(1) Background: the main objective of this study was to investigate information needs concerning sexual activity and experienced sexual problems in heart failure (HF) patients and, in addition, to examine the association between these sexual problems and health-related quality of life (HRQoL); (2) Methods: in this cross-sectional study, three self-administered questionnaires were distributed to 77 stable ambulatory HF patients to acquire data on HRQoL, sexual problems, and need for counselling; (3) Results: More than half (56.7%) of HF patients experienced a marked decrease or total cessation of sexual activity due to their illness. Additionally, more than one-third perceived a marked decrease or total absence of sexual pleasure (42.5%), interest (32.9%), and constant problems or being unable to perform sexual activity (37.3%). Furthermore, 43.1% of patients experienced an important overall need for counselling concerning sexual activity, with information on relationships (69.2%), symptoms (58.5%), and relaxation (49.2%) being the most desired topics. Multiple linear regression analysis revealed that sexual problems were independently associated with HRQoL, with more sexual problems (t = 3.19, p < 0.01) being related to poor HRQoL; (4) Conclusion: by investigating the experienced problems and counselling needs of HF patients, an alignment between current practice and HF patients' expectations and needs might be obtained.

A Personal Decision Support System for Heart Failure Management (HeartMan): study protocol of the HeartMan randomized controlled trial.

BACKGROUND: Heart failure (HF) is a highly prevalent chronic disease, for which there is no cure available. Therefore, improving disease management is crucial, with mobile health (mHealth) being a promising technology. The aim of the HeartMan study is to evaluate the effect of a personal mHealth system on top of standard care on disease management and health-related quality of life (HRQoL) in HF. METHODS: HeartMan is a randomized controlled 1:2 (control:intervention) proof-of-concept trial, which will enrol 120 stable ambulatory HF patients with reduced ejection fraction across two European countries. Participants in the intervention group are equipped with a multi-monitoring health platform with the HeartMan wristband sensor as the main component. HeartMan provides guidance through a decision support system on four domains of disease management (exercise, nutrition, medication adherence and mental support), adapted to the patient's medical and psychological profile. The primary endpoint of the study is improvement in self-care and HRQoL after a six-months intervention. Secondary endpoints are the effects of HeartMan on: behavioural outcomes, illness perception, clinical outcomes and mental state. DISCUSSION: HeartMan is technologically the most innovative HF self-management support system to date. This trial will provide evidence whether modern mHealth technology, when used to its full extent, can improve HRQoL in HF. TRIAL REGISTRATION: This trial has been registered on https://clinicaltrials.gov/ct2/show/NCT03497871 , on April 13 2018 with registration number NCT03497871.

Factors associated with health-related quality of life in stable ambulatory congestive heart failure patients: Systematic review.

Background Since improved treatment of congestive heart failure has resulted in decreased mortality and hospitalisation rates, increasing self-perceived health-related quality of life (HRQoL) has become a major goal of congestive heart failure treatment. However, an overview on predictieve factors of HRQoL is currently lacking in literature. Purpose The aim of this study was to identify key factors associated with HRQoL in stable ambulatory patients with congestive heart failure. Methods A systematic review was performed. MEDLINE, Web of Science and Embase were searched for the following combination of terms: heart failure, quality of life, health perception or functional status between the period 2000 and February 2017. Literature screening was done by two independent reviewers. Results Thirty-five studies out of 8374 titles were included for quality appraisal, of which 29 were selected for further data extraction. Four distinct categories grouping different types of variables were identified: socio-demographic characteristics, clinical characteristics, health and health behaviour, and care provider characteristics. Within the above-mentioned categories the presence of depressive symptoms was most consistently related to a worse HRQoL, followed by a higher New York Heart Association functional class, younger age and female gender. Conclusion Through a systematic literature search, factors associated with HRQoL among congestive heart failure patients were investigated. Age, gender, New York Heart Association functional class and depressive symptoms are the most consistent variables explaining the variance in HRQoL in patients with congestive heart failure. These findings are partly in line with previous research on predictors for hard endpoints in patients with congestive heart failure.

The impact of drop-out in cardiac rehabilitation on outcome among coronary artery disease patients.

Background The effect of adherence to cardiac rehabilitation (CR) on outcome is not clear. Therefore, we aimed to assess the impact of drop-out for non-medical reasons of CR on event-free survival in coronary artery disease (CAD). Methods A total of 876 patients who attended CR after acute coronary syndrome (ACS), percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) were included. Drop-out was defined as attending ≤50% of the training sessions. A combined endpoint of all-cause mortality and rehospitalization for a cardiovascular event was used to specify event-free survival. Differences in clinical characteristics were assessed and parameters with p < 0.10 were entered in a multiple Cox regression analysis. Results A total of 15% died or had a cardiovascular event during a median follow-up period of 33 months (interquartile range 24, 51). Overall, 17% dropped out before finishing half of the program. Patients who withdrew prematurely had a risk twice as high for a cardiovascular event or death (hazard ratio 1.92, 95% confidence interval 1.28-2.90) than those who attended more than half of the sessions. Both ACS (2.36, 1.47-3.58) and PCI (2.20, 1.22-3.96), as primary indicators for CR, were associated with an adverse outcome and also a prior history of chronic heart failure (CHF) remained negatively associated with event-free survival (3.67, 1.24-10.91). Finally, the presence of hyperlipidemia was independently related to a worse outcome (1.48, 1.02-2.16). Conclusions Drop-out for non-medical reasons was independently associated with a negative outcome in CAD. Therefore, underlying factors for drop-out should gain more attention in future research and should be taken into account when organizing CR.

Physical Activity Status in Patients With Coronary Heart Disease: Results From the Cross-Sectional EUROASPIRE Surveys.

BACKGROUND: The study aim was to assess the physical activity levels as well as the intention to become physically active in patients with stable coronary heart disease (CHD) with a special focus on the association with their risk profile. METHODS: Analyses are based on the cross-sectional EUROASPIRE IV surveys. Information was available on 8966 patients in EUROASPIRE III and on 7998 patients in EUROASPIRE IV. Physical activity level according to patients risk profile and their medical management was assessed, the intention to become physically active was investigated and a time trend analysis was performed. RESULTS: A better cardiovascular risk profile as well as receiving physical activity advice or weight loss advice was associated with better physical activity levels. The physical activity status improved significantly over time, the proportion of patients reporting vigorous physical activity for at least 20 minutes ≥ 3 times/week increased from 14.1% to 20.2% (P < .001). Similarly, a significantly greater proportion of patients are in the maintenance stage (36.6% vs. 27.4%) and a smaller proportion in the precontemplation stage (43.2% vs. 52.3%). CONCLUSION: Although an increase was seen in the proportion of patients being adequately physical active, physical activity levels remain suboptimal in many CHD patients.