scholarly journals Process evaluation of a randomised pilot trial of home-based rehabilitation compared to usual care in patients with heart failure with preserved ejection fraction and their caregiver’s (REACH-HFpEF pilot study)

2020 ◽  
Author(s):  
Karen Smith ◽  
Chim Lang ◽  
Jenny Wingham ◽  
Julia Frost ◽  
Colin Greaves ◽  
...  

Abstract Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. Methods: Process evaluation sub-study parallel to a single centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients’ and caregivers’ experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers.Results: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention. The differing professional backgrounds demonstrate the possibility of delivering REACH-HF by either existing HF or cardiac rehabilitation services of a combination of the two.Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a cardiac rehabilitation intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial.Trial registration: ISRCTN78539530 (date registration 7th July 2015) http://www.isrctn.com/ISRCTN78539530

2020 ◽  
Author(s):  
Karen Smith ◽  
Chim Lang ◽  
Jenny Wingham ◽  
Julia Frost ◽  
Colin Greaves ◽  
...  

Abstract Background: Whilst almost 50 percent of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. Methods: Process evaluation sub-study parallel to a single centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients’ and caregivers’ experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers.Results: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation or both. .Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial.Trial registration: ISRCTN78539530 (date registration 7th July 2015) http://www.isrctn.com/ISRCTN78539530


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Karen Smith ◽  
◽  
Chim Lang ◽  
Jennifer Wingham ◽  
Julia Frost ◽  
...  

Abstract Background Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. Methods Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients’ and caregivers’ experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers. Results Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both. Conclusions The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial. Trial registration ISRCTN78539530 (date of registration 7 July 2015).


2020 ◽  
Author(s):  
Karen Smith ◽  
Chim Lang ◽  
Jenny Wingham ◽  
Julia Frost ◽  
Colin Greaves ◽  
...  

Abstract Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is emerging growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. This study reports the process evaluation conducted as part of the REACH-HFpEF trial. Methods: Mixed methods Pprocess evaluation sub study parallel to a single centre (Tayside, Scotland) pilot randomised controlled trial with qualitativequantitative assessment of both intervention fidelity delivery and a qualitative exploration of HFpEF patients’ and caregivers’ experiences. The Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Data included audio-recorded intervention sessions; demographic information; intervention fidelity scores; and qualitative interviews conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers.,Results: Intervention fidelity analysis was indicative of the adequate delivery of the majority of the REACH-HF components, with three items relating caregiver involvement (addressing emotional consequences of being a caregiver, caregiver health and well-being, and closure of the session) scoring poorly. Qualitative information from the facilitator interactions and interviews identified three key themes and a number of sub-themes for patients and caregivers: (1) understanding their condition (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention were uncovered by qualitative interviews. Different professional backgrounds and typical models of service delivery of facilitators demonstrate to possibility of delivering this through either our HF or CR services of a combination of the two.Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a CR intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results of this study will inform a future recently funded full multicentre randomised clinical trial.


2020 ◽  
Vol 13 (10) ◽  
Author(s):  
Kentaro Kamiya ◽  
Yukihito Sato ◽  
Tetsuya Takahashi ◽  
Miyuki Tsuchihashi-Makaya ◽  
Norihiko Kotooka ◽  
...  

Background: Exercise-based cardiac rehabilitation (CR) improves health-related quality of life and exercise capacity in patients with heart failure (HF). However, CR efficacy in patients with HF who are elderly, frail, or have HF with preserved ejection fraction remains unclear. We examined whether participation in multidisciplinary outpatient CR is associated with long-term survival and rehospitalization in patients with HF, with subgroup analysis by age, sex, comorbidities, frailty, and HF with preserved ejection fraction. Methods: This multicenter retrospective cohort study was performed in patients hospitalized for acute HF at 15 hospitals in Japan, 2007 to 2016. The primary outcome (composite of all-cause mortality and HF rehospitalization after discharge) and secondary outcomes (all-cause mortality and HF rehospitalization) were analyzed in outpatient CR program participants versus nonparticipants. Results: Of the 3277 patients, 26% (862) participated in outpatient CR. After propensity matching for potential confounders, 1592 patients were included (n=796 pairs), of which 511 had composite outcomes (223 [14%] all-cause deaths and 392 [25%] HF rehospitalizations, median 2.4-year follow-up). Hazard ratios associated with CR participation were 0.77 (95% CI, 0.65–0.92) for composite outcome, 0.67 (95% CI, 0.51–0.87) for all-cause mortality, and 0.82 (95% CI, 0.67–0.99) for HF-related rehospitalization. CR participation was also associated with numerically lower rates of composite outcome in patients with HF with preserved ejection fraction or frail patients. Conclusions: Outpatient CR participation was associated with substantial prognostic benefit in a large HF cohort regardless of age, sex, comorbidities, frailty, and HF with preserved ejection fraction.


Author(s):  
Marco Guazzi ◽  
Robert Naeije

The health burden of heart failure with preserved ejection fraction is increasingly recognized. Despite improvements in diagnostic algorithms and established knowledge on the clinical trajectory, effective treatment options for heart failure with preserved ejection fraction remain limited, mainly because of the high mechanistic heterogeneity. Diagnostic scores, big data, and phenomapping categorization are proposed as key steps needed for progress. In the meantime, advancements in imaging techniques combined to high-fidelity pressure signaling analysis have uncovered right ventricular dysfunction as a mediator of heart failure with preserved ejection fraction progression and as major independent determinant of poor outcome. This review summarizes the current understanding of the pathophysiology of right ventricular dysfunction in heart failure with preserved ejection fraction covering the different right heart phenotypes and offering perspectives on new treatments targeting the right ventricle in its function and geometry.


2019 ◽  
Vol 18 (7) ◽  
pp. 621-627 ◽  
Author(s):  
Patricia Palau ◽  
Eloy Domínguez ◽  
José María Ramón ◽  
Laura López ◽  
Antonio Ernesto Briatore ◽  
...  

Background:Heart failure with preserved ejection fraction is a clinical syndrome characterised by reduced exercise capacity. Some evidence has shown that a simple and home-based programme of inspiratory muscle training offers promising results in terms of aerobic capacity improvement in patients with heart failure with preserved ejection fraction. This study aimed to investigate whether the baseline inspiratory muscle function predicts the changes in aerobic capacity (measured as peak oxygen uptake; peak VO2) after a 12-week home-based programme of inspiratory muscle training in patients with heart failure with preserved ejection fraction.Methods:A total of 45 stable symptomatic patients with heart failure with preserved ejection fraction and New York Heart Association II–III received a 12-week home-based programme of inspiratory muscle training between June 2015 and December 2016. They underwent cardiopulmonary exercise testing and measurements of maximum inspiratory pressure pre and post-inspiratory muscle training. Maximum inspiratory pressure and peak VO2were registered in both visits. Multivariate linear regression analysis was used to assess the association between changes in peak VO2(Δ-peakVO2) and baseline predicted maximum inspiratory pressure (pp-MIP).Results:The median (interquartile range) age was 73 (68–77) years, 47% were women and 35.6% displayed New York Heart Association III. The mean peak VO2at baseline and Δ-peakVO2post-training were 10.4±2.8 ml/min/kg and +2.2±1.3 ml/min/kg (+21.3%), respectively. The median (interquartile range) of pp-MIP and Δ-MIP were 71% (64–92) and 39.2 (26.7–80.4) cmH2O, respectively. After a multivariate analysis, baseline pp-MIP was not associated with Δ-peakVO2(β coefficient 0.005, 95% confidence interval −0.009–0.019, P=0.452).Conclusions:In symptomatic and deconditioned older patients with heart failure with preserved ejection fraction, a home-based inspiratory muscle training programme improves aerobic capacity regardless of the baseline maximum inspiratory pressure.


2020 ◽  
Vol 9 (11) ◽  
pp. 3669 ◽  
Author(s):  
René Rettl ◽  
Theresa-Marie Dachs ◽  
Franz Duca ◽  
Christina Binder ◽  
Fabian Dusik ◽  
...  

The PARAGON-HF clinical trial suggested that sacubitril/valsartan may become a treatment option for particular subgroups of patients with heart failure and preserved ejection fraction (HFpEF). However, the proportion of real-world HFpEF patients who are theoretically superimposable with the PARAGON-HF population is yet unknown. The present study was performed to define the proportion of real-world PARAGON-HF-like patients and to describe their clinical characteristics and long-term prognosis in comparison with those who would not meet PARAGON-HF criteria. We systematically applied PARAGON-HF inclusion and exclusion criteria to a total of 427 HFpEF patients who have been participating in a prospective national registry between December 2010 and December 2019. In total, only 170 (39.8%) registry patients were theoretically eligible for PARAGON-HF. Patients not meeting inclusion criteria (41.0%) were less impaired with respect to exercise capacity (median 6-min walk distance: 385 m (IQR: 300–450) versus 323 m (IQR: 240–383); p < 0.001) had lower pulmonary pressures (mean pulmonary artery pressure (mPAP): 31.2 mmHg, standard deviation (SD): ±10.2 versus 32.8 mmHg, SD: ±9.7; p < 0.001) and better outcomes (log-rank: p < 0.001) as compared to the PARAGON-like cohort. However, patients theoretically excluded from the trial (19.2%) were those with most advanced heart failure symptoms (median 6-min walk test: 252 m (IQR: 165–387); p < 0.001), highest pulmonary pressures (mPAP: 38.2 mmHg, SD: ±12.4; p < 0.001) and worst outcome (log-rank: p = 0.037). We demonstrate here that < 40% of real-world HFpEF patients meet eligibility criteria for PARAGON-HF. We conclude that despite reasons for optimism after PARAGON-HF, a large proportion of HFpEF patients will remain without meaningful treatment options.


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