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Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST).

ABSTRACT: BACKGROUND:Qiliqiangxin (QLQX) capsule is a Traditional Chinese Medicine (TCM) that has been approved in China for the treatment of chronic heart failure (CHF). Our previous study showed with a background of standard HF treatment, QLQX capsules further reduced the levels of NT-proBNP and the incidence of composite cardiac events (CCEs) in CHF patients. This study aims to further assess the reduction in mortality when using QLQX compared with placebo for heart failure with reduced ejection fraction (HFrEF) patients. METHODS:This study is a randomized, double-blind, placebo-controlled, parallel-group, multi-center, event-driven clinical study of approximately 3080 patients for a targeted 620 events. Patients must have a diagnosis of heart failure for at least 3 months prior to screening. Patients will be randomized 1:1 to receive the placebo or QLQX in addition to their standard medications of CHF. The primary efficacy outcome event is a composite cardiovascular death and re-hospitalization due to the worsening of heart failure. DISCUSSION:The QUEST study is a randomized control study of TCM in chronic heart failure. It will determine the place of QLQX as an new treatment approach and provide additional and innovative information regarding TCM - and the specific used of QLQX in HFrEF. TRIAL REGISTRATION:The trial was registered at http://www.chictr.org.cn. ( Registration No.: ChiCTR1900021929); Date: 2019-03-16.

SUBMITTER: Yao W

PROVIDER: S-EPMC7076750 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST).

Yao Wenming W Cheang Iokfai I Liao Shengen S Zhou Yanli Y Zhou Fang F Xu Dongjie D Jia Zhenhua Z Chang Liping L Zhang Haifeng H Li Xinli X

BMC complementary medicine and therapies 20200205 1

<h4>Background</h4>Qiliqiangxin (QLQX) capsule is a Traditional Chinese Medicine (TCM) that has been approved in China for the treatment of chronic heart failure (CHF). Our previous study showed with a background of standard HF treatment, QLQX capsules further reduced the levels of NT-proBNP and the incidence of composite cardiac events (CCEs) in CHF patients. This study aims to further assess the reduction in mortality when using QLQX compared with placebo for heart failure with reduced ejectio ...[more]

PMID: 32024496

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Project description:BackgroundHeart failure (HF) is the leading cause of hospitalization among older adults in the United States. There are substantial racial and geographic disparities in HF outcomes, with patients living in southern US states having a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight monitoring and physical activity, are extremely important in improving HF outcomes; however, patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) have become a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable and scalable and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also becoming increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes.ObjectiveThis randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors.MethodsA total of 200 participants with HF, aged ≥45 years, will be recruited and randomized into 2 groups: the SCDG playing group (intervention group) and sensor-only group (control group). Both groups will receive a weight scale, physical activity tracker, and accompanying app, whereas only the intervention group will play the SCDG. This design, thereby, assesses the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention. They will also complete a third posttest at 24 weeks to assess the maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight monitoring and physical activity) and distal outcomes (HF hospitalization, quality of life, and functional status) between baseline and weeks 6, 12, and 24. The primary outcome measured will be days with weight monitoring, for which this design provides at least 80% power to detect differences between the 2 groups.ResultsRecruitment began in the fall of 2022, and the first patient was enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in quarter 1 of 2025. Publication of complete results and data from this study is expected in 2026.ConclusionsThis project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF.Trial registrationClinicalTrials.gov NCT05056129; https://clinicaltrials.gov/ct2/show/NCT05056129.International registered report identifier (irrid)DERR1-10.2196/45801.

Project description:BackgroundCardiovascular disease is the leading cause of mortality worldwide, accounting for 13%-15% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients' participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called "Future Patient" has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals.ObjectiveThe aim of this paper is to describe the research design, outcome measures, and data collection techniques in the clinical test of the Future Patient Telerehabilitation Program for patients with heart failure.MethodsA randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients', spouses', and health care professionals' experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies.ResultsData collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020.ConclusionsThe expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure.Trial registrationClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918.International registered report identifier (irrid)DERR1-10.2196/14517.

Project description:BACKGROUND:Several heart failure studies have shown promising results for implementing telehealthcare. These studies have led to clinical and political interest in telehealthcare as a way to improve heart failure outcomes and lower costs. However, there is a need for large-scale clinical trials with cost-effectiveness assessments. METHODS/DESIGN:The present study is known as the TeleCare North Heart Failure Trial in Denmark. We are studying the health effectiveness and cost-effectiveness of a telehealth (Telekit) solution compared with usual care for patients with heart failure. The design is a multicenter, two-arm, parallel-group, nonblinded, superiority randomized controlled trial. Outpatient healthcare centers will be responsible for recruiting eligible participants (600 participants are expected) for the trial in the geographic area of the North Denmark Region. Participants are qualified for inclusion if they have been diagnosed according to national guidelines and are categorized in New York Heart Association class 2, 3, or 4. Patients must have a permanent residence and be motivated to use telehealth care. The primary outcomes are changes in health-related quality of life (assessed using the Kansas City Cardiomyopathy Questionnaire, the EuroQol EQ-5D-5L questionnaire, and the Short Form Health Survey [SF-36]) and in the incremental cost-effectiveness ratio measured from baseline to follow-up. The secondary outcomes are changes in mortality and in physiological indicators such as blood pressure, pulse, and weight. DISCUSSION:The TeleCare North Heart Failure Trial is intended to improve the international evidence base for the health effectiveness and cost-effectiveness of telehealthcare for patients with heart failure. The expectation is that the results of the trial can be generalized to all municipalities in Denmark and serve as an inspiration for further international research. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02860013 ). Registered on 28 July 2016.

Project description:BackgroundHeart failure (HF) is characterized by an increasing prevalence, representing a public health problem and a significant cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF. Patients play a crucial role in managing their condition, given that several adverse health outcomes might be avoided with adequate self-care. In this regard, the literature describes motivational interviewing (MI) as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF.ObjectiveThe primary study aim is to test the efficacy of a structured program, including scheduled MI interventions, in improving self-care maintenance in the 3-month follow-up from the enrollment. Secondary aims comprehend the assessment of the effectiveness of the above intervention on secondary outcomes (eg, self-care monitoring, quality of life, sleep disturbance) and the corroboration of the superiority of caregivers' participation to the intervention over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes at 3, 6, 9, and 12 months from the enrollment.MethodsThis study protocol designed a prospective, parallel-arm, open-label, 3-arm, controlled trial. The MI intervention will be administered by nurses trained in HF self-care and MI; the education program will be provided to nurses by an expert psychologist. Analyses will be performed within the framework of intention-to-treat analysis. Comparisons between groups will be based on an alpha of 5% and 2-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods.ResultsThe data collection was started in May 2017. We completed the data collection with the last follow-up in May 2021. We plan to perform data analysis by December 2022. We plan to publish the study results within March 2023.ConclusionsMI enhances potential self-care practices in patients with HF and their caregivers. Although MI is effectively largely employed either alone or combined with other treatments and is administered in different settings and ways, face-to-face interventions seem to be more effective. Dyads with higher shared HF knowledge are more efficient in promoting self-care adherence behaviors. Moreover, patients and caregivers may perceive proximity with health care professionals, resulting in a better ability to follow the received health professionals' directions. The scheduled in-person meetings with patients and caregivers will be exploited to administer MI, respecting all the safety regulations for infection containment. The conduction of this study may support changes in clinical practice to include MI to improve self-care for patients with HF.Trial registrationClinicalTrials.gov NCT05595655; https://clinicaltrials.gov/ct2/show/NCT05595655.International registered report identifier (irrid)DERR1-10.2196/44629.

Dataset Information

Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST).

Publications

Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST).

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