Circulation, Volume 148, Issue Suppl_1, Page A13569-A13569, November 6, 2023. Introduction:Heart failure (HF) poses a global health burden, with about 26 million people affected and an estimated health expenditure of US$31 billion worldwide . The outcome of HF patients with reduced ejection fraction (HFrEF) has improved significantly due to the availability of evidence-based therapies. Still, the readmission rates, and subsequent mortality, have remained unchanged in the last two decades. Despite immense positive evidence, < 25% of patients with HFrEF are on the appropriate target doses of medical therapy.Objectives:Impact of intense versus routine outpatient follow-up on clinical outcomes and patient satisfaction in Acute decompensated heart failure (ADHF) patients over a 3-month follow-up.METHODS: This is a prospective open-label randomized study analyzing readmission rates and achieving target doses of GDMT.Results:A total of 226 subjects (Intense smartphone application-based follow-up -112) (routine outpatient follow-up -114) were enrolled in the study. The mean age was 53 and 54 years in intense follow-up and routine follow up, respectively. Both study arms were well-matched and randomized. There was a significant reduction in rehospitalization rate in the intense follow-up arm (28 vs. 57) p - 0.005. Subjects on smartphone application-based follow-up had better drug compliance and a rapid escalation of GDMT to reach target doses.Number of patients on target dose of GDMT at three monthsConclusion:Intense smartphone application based follow-up was feasible and safe for ADHF patients. The incidence of 30-day and three months readmissions improved. They also showed improved BP, HR, and NT Pro-BNP levels. Drug dosages were up-titrated periodically in these subsets of patients based on their cardiac function and laboratory parameters. Newer apps should be designed to incorporate artificial intelligence (AI) with features more likely to improve key patient-reported and clinical outcomes.
Risultati per: Follow-up ottimale dopo embolia polmonare acuta
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Abstract 321: Manual vs Automated Ventilation During Automated Head-Up Cardiopulmonary Resuscitation in a Porcine Model
Circulation, Volume 148, Issue Suppl_1, Page A321-A321, November 6, 2023. Background:The efficacy of mechanical ventilation during CPR with the combination of active compression-decompression, an impedance threshold device, and head-up positioning, collectively termed automated head-up (AHUP)-CPR, is unknown.Hypothesis:Hemodynamic and ventilatory parameters will be similar with manual bag ventilation (MBV) versus automated bag ventilation (ABV) during AHUP-CPR in a porcine model of cardiac arrest.Aim:Assess the proof-of-concept that ABV is safe and effective during AHUP-CPR.Methods:Nine male and female swine (~40 kg) were anesthetized and ventilated. VF was induced and left untreated for 8 min. AHUP-CPR was performed at 105 compressions/min for 7 min using MBV, followed by 6 min using an automated mechanical bag compressor to deliver 10ml/kg of tidal volume (TV) over 1 sec at 10 breaths/min. Pigs were randomized during ABV to a synchronized (Sync) breath delivered at the start of decompression or an asynchronous (Async) breath. Cerebral perfusion pressure, coronary perfusion pressure, end-tidal CO2, intracranial pressure, esophageal intrathoracic pressure, peak airway pressure (PAP), inspiratory and expiratory TVs as well as arterial blood gases were continuously measured. Values (mean ± SD) were compared by paired and unpaired student’s t-tests with a Bonferroni correction.Results:Parameters during the last minute of MBV and ABV are summarized in the table. No significant differences were observed in hemodynamic and ventilatory parameters, except for PAP and pO2 values which were significantly lower with MBV. No significant differences were also observed between the Sync and Async ABV modes.Conclusion:Manual and mechanical ventilation resulted in overall similar physiological effects. The clinical relevance of the observed significant differences in PAP and pO2 is unclear. Additional studies are warranted to further assess the safety and effectiveness of mechanical ventilation during AHUP-CPR.
Abstract 18480: Type 2 Diabetic Patients Have Increased Coronary Plaque Burden and Plaque Progression During 10-Year Serial Coronary CT Angiography Follow-Up
Circulation, Volume 148, Issue Suppl_1, Page A18480-A18480, November 6, 2023. BackgroundIndividuals diagnosed with type 2 diabetes are at high risk for coronary artery disease, however, data on long-term progression of coronary artery plaque burden is lacking. This study investigated atherosclerotic plaque characteristics and long-term plaque progression in patients with and without type 2 diabetes mellitus (T2DM).Methods:Per-protocol, patients from a coronary CT angiography (CCTA) cohort were invited for repeat CCTA imaging, regardless of symptoms. A total of 299 patients underwent follow-up CCTA imaging with a median scan interval of 10.2 [IQR 8.7-11.2] years. Patients who underwent coronary artery bypass grafting and vessels revascularized by percutaneous coronary intervention were excluded. Scans were analyzed using atherosclerosis imaging-quantitative CCTA (AI-QCT; Cleerly Inc.). The associations between diabetic status, baseline and follow-up plaque burden and characteristics were evaluated using multivariable regression adjusted for clinical risk factors, statin use and scanner settings.Results:In total, 274 patients were included, 43 (15.7%) had T2DM at baseline. The mean age was 57±7 years, 42% were women. At baseline, patients with T2DM had a median percent atheroma volume (PAV) of 6.80 (2.80, 17.70) at baseline; patients without T2DM had a median PAV of 3.20 (0.80, 9.55). Adjusted for clinical risk factors, patients with T2DM had a higher rate of plaque progression (Figure 1). The difference in PAV caused by T2DM was similar to the effect of a 13-year age difference. At baseline patients with T2DM had a higher prevalence of high-risk plaque (OR 2.11; p=0.025). After 10 years of follow-up, patients with T2DM had a higher prevalence of both high-risk plaque (OR 3.49; p
Abstract 14254: Myocarditis in Athletes and Non-Athletes: Evaluating the Persistence and Degree of Myocardial Fibrosis at Follow Up
Circulation, Volume 148, Issue Suppl_1, Page A14254-A14254, November 6, 2023. Introduction:Myocarditis is a common acquired cardiac disorder that may lead to persistent scar. Current guidelines recommend follow up cardiac MRI (CMR) in 3-6 months for athletes. Data supporting this recommendation is unfortunately very limited.Aim:The aim of this study was to evaluate the demographic and clinical variables of patients diagnosed with myocarditis. Clinical data for those who had a follow up CMR was also evaluated separately.Methodology:Patients who had a cardiac MRI (CMR) organised between July 2019 till December 2022 because of a MINOCA/Myocarditis hospital admission were retrospectively reviewed. Those with a myocarditis diagnosis were included. An athlete was defined as an individual who engaged in >4 hours of physical activity weekly or underwent organized sport.Results:105 patients were included (mean age 35.4±15.6 years, 83.8% male). 34.3% were athletes. 12.4% had possible acute myocarditis, 10.5% had likely myocarditis and 77.1% had confirmed myocarditis on cardiac MRI (median 4 days from presentation). ECG was abnormal in 60.0%. 8.6% had arrhythmias. Echocardiography was abnormal in 26.7%. CMR revealed 15.2% reduced LV EF, 57.1% regional wall motion abnormalities, 5.7% reduced RV EF, 25.7% pericardial effusion, 84.5% myocardial oedema. Most (88.5%) had late gadolinium enhancement (LGE). 56.2% were started on anti-heart failure medical therapy.29.5% had a CMR repeated (interval between scans 14.7±14.2 months). 77.4% showed persistent LGE, less pronounced in most (71.0%). Diffuse LGE at baseline was the only predictor for persistent scar (p=0.004). Scar persisted equally in athletes and non-athletes (p=0.666). Clinical variables were similar in both.At follow-up (24.6±15.3 months), 8.6% had adverse outcomes. The event rate was similar in athletes and non-athletes. A low LV EF on CMR (p=0.011) and abnormal ECHO (p=0.027) were the only variables that could predict outcome.Conclusion:LGE after myocarditis persists in 77.4% of cases, albeit better. No variable could predict the persistence of LGE in this cohort. Athletes and non-athletes had a similar clinical course, suggesting that repeat CMR in non-athletes is reasonable. The diagnostic utility of repeat CMR after myocarditis remains questionable.
Abstract 17863: Analysis of Social Determinants of Health, Burden of Treatment and Quality of Life in Patients With Heart Failure With Preserved and Reduced Ejection Fraction, a Single Center Study With Six Months Follow Up
Circulation, Volume 148, Issue Suppl_1, Page A17863-A17863, November 6, 2023. Introduction:Heart failure (HF) is a chronic debilitating disease with immense burden on the patient’s life. This study aims to investigate the clinical characteristics, social determinants of health (SDOH), burden of treatment (BoT), and quality of life (QoL) of patients with heart failure with preserved and reduced ejection fraction (HFpEF and HFrEF).Methods:Data from 191 patients (63 HFpEF, 128 HFrEF) were collected from February 2022 to March 2023. Validated questionnaires including SDoH, BoT and QoL were filled by the patient on admission and in 6 months as a follow up. Descriptive statistics were used to compare the demographic and clinical characteristics of HFpEF and HFrEF patients. Inferential statistics, including logistic regression, were used to analyze the associations between SDOH, BoT, QoL, and 30-day readmission rates.Results:Distribution between both groups is similar to the general population. HFpEF patients experienced more interpersonal challenges and reported greater difficulty with self-care and usual activities. HFrEF patients had higher rates of substances, alcohol, and tobacco use. Regarding readmission, HFpEF patients with medication difficulties and HFrEF patients with difficulty accessing healthcare services were more likely to be readmitted. Both HFrEF and HFpEF patients showed significant improvement in SDOH, QoL and BoT in the follow up data (Table 1).Conclusions:The study findings highlight the distinct clinical characteristics, SDOH, BoT, and QoL factors associated with HFpEF and HFrEF. These findings can contribute to targeted interventions and improved patient care. Moreover, the study emphasizes the importance of addressing social and personal factors influencing HF outcomes, aiming to reduce healthcare disparities and improve patient well-being. The results have implications for healthcare providers, policymakers, and researchers in improving the management and outcomes of heart failure patients.
Abstract 320: Survival and Neurological Function With Rapid versus Delayed Automated Head-Up CPR in a Porcine Model of Prolonged Cardiac Arrest
Circulation, Volume 148, Issue Suppl_1, Page A320-A320, November 6, 2023. Background:Rapid Basic Life Support (BLS) treatment with controlled sequential elevation of the head and thorax, active compression-decompression CPR, and an impedance threshold device, collectively termed automated Head Up Position (AHUP)-CPR, is associated with better outcomes versus conventional CPR (C-CPR) in animal models and human observational studies.Hypothesis:Rapid AHUP-CPR should improve survival and neurological function vs rapid C-CPR followed by delayed AHUP-CPR.Aim:Determine if AHUP-CPR should be initiated as a BLS or ALS intervention.Methods:Male and female farm pigs (n=22) weighing~40kg were anesthetized and ventilated. Central venous and aortic pressures, as well as end-tidal CO2 (ETCO2) and cerebral oximetry (rSO2) were measured continuously. After 15 min of untreated VF, pigs were randomized to either rapid AHUP-CPR for 25 min or 10 min of C-CPR followed by 15 min of AHUP-CPR. Pigs received intravenous epinephrine and amiodarone after 24 min of CPR and were defibrillated 60 sec later. For the primary endpoint, 24-hour neurologic function, a veterinarian blinded to the CPR intervention assessed pigs using a Neurological Deficit Score (0 = normal and 260 = worst deficit score or death). Secondary outcomes included 24-hour survival rates and hemodynamic parameters. Data were expressed as mean ± SD. Statistical significance was determined by log-rank, Mann-Whitney-U and unpaired t-tests.Results:Sustained return of spontaneous circulation was achieved in 10/11 pigs with rapid AHUP-CPR vs 6/11 with delayed AHUP-CPR and cumulative 24-hour survival rates were 45.5% (5/11) vs 9.1% (1/11), respectively (p=0.01). Neurological Deficit Scores were 202.7 ± 80.3 with rapid AHUP-CPR vs 259.1 ± 3.0 with delayed AHUP-CPR group (p=0.04). Ten minutes after initiating CPR, ETCO2 (mmHg) was 45.0 ± 3.8 vs 26.9 ± 5.4 (p
Abstract 14087: Physical Activity is Associated With Monocytes and Monocyte Subsets in Low-Resourced Neighborhoods: Data From the Step It Up Physical Activity Intervention
Circulation, Volume 148, Issue Suppl_1, Page A14087-A14087, November 6, 2023. Background:Physical activity (PA) reduces cardiovascular disease (CVD) risk; those living in lower-resourced neighborhoods have higher CVD risk in part due to limited PA access. Monocyte subsets (classical, intermediate, and non-classical) with their platelet aggregates (PlAgg) are key in CVD, but less is known about relationships between PA and monocytes. We investigated associations between PA and monocyte subsets with PlAgg in African American (AA) women at risk for CVD living in resource-limited Washington, DC areas.Methods:Participants were enrolled in Step It Up, a technology-enabled, community-engaged PA intervention. Baseline PA was measured as daily step counts using a FitBit Charge 2. Monocyte subsets and PlAgg were measured in fasting blood samples by flow cytometry. Multivariable linear regression was used to determine relationships between PA and monocytes adjusting for BMI and ASCVD 10-year risk score. We examined neighborhood deprivation index (NDI), a 2018 Census-tract based measure of neighborhood socioeconomic deprivation, as a moderator of associations between PA and monocytes.Results:The study cohort was a sample of AA women with overweight/obesity enrolled in Step It Up (N=106, age=57±12 y, BMI=34.8±6.3kg/m2). Higher baseline PA associated with monocyte subsets, but not overall monocyte presence (Table). Furthermore, higher baseline PA negatively associated with PlAgg on all monocytes. PA and monocyte subsets were most associated among those residing in higher deprivation neighborhoods (Table).Conclusion:Baseline PA was associated with monocyte subsets and lower monocyte-PlAgg formation among AA women living in lower-resourced conditions. Future work should examine the relationship between PA changes and changes in monocyte subsets in community engaged PA interventions like Step It Up, particularly among those residing in limited resource communities.
Abstract 17274: Frequency of Cardiology Follow-Up in Childhood Cancer Patients
Circulation, Volume 148, Issue Suppl_1, Page A17274-A17274, November 6, 2023. Background:Childhood cancer survivors (CCS) are at risk of early or late-stage cardiotoxicity, the third leading cause of death in CCS. American Heart Association Scientific statement stresses the importance of timely follow-up of CCS. Children’s Oncology Group (COG) has also recommended serial cardiac testing based on therapy doses. However, compliance of cardiac follow-up is not known.Hypothesis:Cardiology follow-up in CCS is poor and needs improvement.Goal:Our goal is to identify factors that limit timely cardiology follow-up.Methods:We retrospectively cross-referenced patients from the oncology clinic with our echocardiogram database, focusing on solid tumor survivors from 1996-2018 that received anthracyclines or cardiac field radiation. Excluding patients not requiring cardiac monitoring, we collected demographic, oncology history and treatment, and cardiac evaluation related data. Based on COG guidelines, we determined if each patient maintained their expected cardiology follow up. We then assessed whether follow up was associated with median household income, medical insurance type, gender, and age at diagnosis using chi square or t-test.Results:A total of 49 patients (24F/25M) met inclusion criteria included. Timely cardiology follow up was only seen in 50% of the patients, regardless of how far out the patients were from treatment. There was no correlation between follow up and median household income, medical insurance, gender, or age of diagnosis (p values >0.05).Conclusions:This data demonstrates there is a major gap in providing key cardiac care to CCS, as 50% of patients did not maintain expected follow up. This finding was irrespective of socioeconomic status or age at diagnosis. This suggests a greater emphasis must be placed on educating families about potential cardiac risks and the need for appropriate follow up care. This can be established through a stronger collaboration between cardiology and oncology programs.
Abstract 14051: The Associations Between Loneliness and Circulating Lipoproteins as Well as Diabetes Risk in African-American Women Residing in Resource-Limited Neighborhoods: Data From the Step It Up Physical Activity Intervention
Circulation, Volume 148, Issue Suppl_1, Page A14051-A14051, November 6, 2023. Background:Loneliness is a public health crisis and recent reports suggest that people suffering from loneliness have increased cardiovascular disease (CVD) risk. A potential link between loneliness and CVD is an atherogenic shift in the lipoprotein profile. We investigated associations between loneliness and lipoproteins in African American (AA) women residing in resource-limited neighborhoods of Washington, DC.Methods:Participants were enrolled in Step It Up, a technology-based, community-engaged PA intervention. Fasting blood samples were drawn at baseline to measure lipoproteins using nuclear magnetic resonance (NMR) technology. The Lipoprotein Insulin Resistance Index (LP-IR), a diabetes risk marker, was calculated. Loneliness was measured using the UCLA Loneliness scale. Associations between loneliness, lipoprotein particles and LP-IR were analyzed using multivariable regression adjusted for BMI, ASCVD 10-year risk score, and lipid-lowering therapy.Results:106 AA women with CVD risk (Age 55.9±13, BMI 36.3±6.7) were enrolled into Step It Up. We found that higher loneliness at baseline was associated with higher Apo-B, LDL concentration (LDL-c), and LDL particle number (LDL-p) but not with LDL particle size (LDL-z, Table). We observed that higher loneliness associated with increased triglyceride rich lipoprotein size (TRL-z). This relationship seems to be due to very large and large TRL particles (TRL-p, Table). No significant associations were found with the HDL-related measures. Lastly, loneliness significantly associated with LP-IR, a new diabetes risk marker (Table).Conclusions:Thus, our data show that higher loneliness in AA women from under resourced neighborhoods is associated with increased hyperlipidemia and diabetes risk. This highlights a potential mechanism by which loneliness may accelerate CVD risk and support the urgent need for multilevel interventions to reduce loneliness and CVD risk in at-risk populations.
Protocol of the Berlin Long-term Observation of Vascular Events (BeLOVE): a prospective cohort study with deep phenotyping and long-term follow up of cardiovascular high-risk patients
Introduction
The Berlin Long-term Observation of Vascular Events is a prospective cohort study that aims to improve prediction and disease-overarching mechanistic understanding of cardiovascular (CV) disease progression by comprehensively investigating a high-risk patient population with different organ manifestations.
Methods and analysis
A total of 8000 adult patients will be recruited who have either suffered an acute CV event (CVE) requiring hospitalisation or who have not experienced a recent acute CVE but are at high CV risk. An initial study examination is performed during the acute treatment phase of the index CVE or after inclusion into the chronic high risk arm. Deep phenotyping is then performed after ~90 days and includes assessments of the patient’s medical history, health status and behaviour, cardiovascular, nutritional, metabolic, and anthropometric parameters, and patient-related outcome measures. Biospecimens are collected for analyses including ‘OMICs’ technologies (e.g., genomics, metabolomics, proteomics). Subcohorts undergo MRI of the brain, heart, lung and kidney, as well as more comprehensive metabolic, neurological and CV examinations. All participants are followed up for up to 10 years to assess clinical outcomes, primarily major adverse CVEs and patient-reported (value-based) outcomes. State-of-the-art clinical research methods, as well as emerging techniques from systems medicine and artificial intelligence, will be used to identify associations between patient characteristics, longitudinal changes and outcomes.
Ethics and dissemination
The study was approved by the Charité—Universitätsmedizin Berlin ethics committee (EA1/066/17). The results of the study will be disseminated through international peer-reviewed publications and congress presentations.
Study registration
First study phase: Approved WHO primary register: German Clinical Trials Register: https://drks.de/search/de/trial/DRKS00016852; WHO International Clinical Registry Platform: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00016852. Recruitment started on July 18, 2017.
Second study phase: Approved WHO primary register: German Clinical Trials Register DRKS00023323, date of registration: November 4, 2020, URL: http://www.drks.de/ DRKS00023323. Recruitment started on January 1, 2021.
Scaling up a school-based intervention to increase physical activity and reduce sedentary behaviour in children: protocol for the TransformUs hybrid effectiveness-implementation trial
Introduction
Efficacious programmes require implementation at scale to maximise their public health impact. TransformUs is an efficacious behavioural and environmental intervention for increasing primary (elementary) school children’s (5–12 years) physical activity and reducing their sedentary behaviour within school and home settings. This paper describes the study protocol of a 5-year effectiveness–implementation trial to assess the scalability and effectiveness of the TransformUs programme.
Methods and analysis
A type II hybrid implementation–effectiveness trial, TransformUs is being disseminated to all primary schools in the state of Victoria, Australia (n=1786). Data are being collected using mixed methods at the system (state government, partner organisations), organisation (school) and individual (teacher, parent and child) levels. Evaluation is based on programme Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. RE-AIM domains are being measured using a quasi-experimental, pre/post, non-equivalent group design, at baseline, 12 and 24 months. Effectiveness will be determined in a subsample of 20 intervention schools (in Victoria) and 20 control schools (in New South Wales (NSW), Australia), at baseline, 12 and 24 months. Primary outcomes include TransformUs Reach, Adoption, Implementation and organisational Maintenance (implementation trial), and children’s physical activity and sedentary time assessed using accelerometers (effectiveness trial). Secondary outcomes include average sedentary time and moderate to vigorous-intensity physical activity on weekdays and during school hours, body mass index z-scores and waist circumference (effectiveness trial). Linear mixed-effects models will be fitted to compare outcomes between intervention and control participants accounting for clustering of children within schools, confounding and random effects.
Ethics and dissemination
The trial was approved by the Deakin University Human Research Ethics Committee (HEAG-H 28_2017), Victorian Department of Education, the NSW Department of Education, Australian Catholic University (2017-145R), Melbourne Archdiocese Catholic Schools and Catholic Schools NSW. Partners, schools/teachers and parents will provide an informed signed consent form prior to participating. Parents will provide consent for their child to participate in the effectiveness trial. Findings will be disseminated via peer-reviewed publications, scientific conferences, summary reports to schools and our partner organisations, and will inform education policy and practice on effective and sustainable ways to promote physical activity and reduce sedentary behaviours population-wide.
Trial registration number
Australian Clinical Trials Registration Registry (ACTRN12617000204347).
Socio-demographic and clinical characteristics associated with retention in care among adults living with HIV and severe mental illness and reasons for loss to follow-up in Uganda: a mixed-methods study
Objective
This study aimed to determine the socio-demographic and clinical characteristics associated with retention in care and reasons for loss to follow-up (LTFU) among people living with HIV (PLWH) with a known diagnosis of severe mental illness (SMI).
Design
We conducted a parallel convergent mixed-methods study. The quantitative study was used to determine the proportion and factors associated with retention in care among PLWH and SMI. The qualitative study explored reasons for LTFU.
Setting
This study was conducted at two the HIV clinics of two tertiary hospitals in Uganda.
Participants
We reviewed records of 608 PLWH who started antiretroviral therapy (ART) and included participants who had a documented diagnosis of SMI.
Outcomes
The primary outcome was retention in care. Age, gender, religion, tuberculosis (TB) status, WHO clinical stage, functional status, cluster of differentiation 4 (CD4) cell count, viral load and SMI diagnosis were among the predictor variables.
Results
We collected data from 328 participants. Retention at 6 months was 43.3% compared with 35.7% at 12 months. Having an unsuppressed viral load (≥1000 copies/mL) (adjusted incidence risk ratio (IRR)=1.54, 95% CI: 1.17 to 2.03), being 36 years and below (adjusted IRR=0.94, 95% CI: 0.94 to 0.95), initial presentation at outpatient department (adjusted IRR=0.74, 95% CI: 0.57 to 0.96), having TB signs and symptoms (adjusted IRR=0.98 95% CI: 0.97 to 0.99) and being in lower WHO stages (I and II) (adjusted IRR=1.08, 95% CI: 1.02 to 1.14) at ART initiation were significantly associated with retention in care at 6 and 12 months. Inadequate social support, long waiting hours at the clinic, perceived stigma and discrimination, competing life activities, low socioeconomic status and poor adherence to psychiatric medication were barriers to retention in care.
Conclusion
Twelve-month retention in care remains low at 35.7% far below the 90% WHO target. There is a need to design and implement targeted interventions to address barriers to retention in care among PLWH and SMI.
Scaling Up Point-of-Care Fentanyl Testing — A Step Forward
New England Journal of Medicine, Ahead of Print.
Scale-up of the Australian Fans in Training (Aussie-FIT) mens health behaviour change program: a protocol for a randomised controlled hybrid effectiveness-implementation trial
Introduction
Improving physical activity (PA) and healthy eating is critical for primary and secondary prevention of cardiovascular disease (CVD). Behaviour change programmes delivered in sporting clubs can engage men in health behaviour change, but are rarely sustained or scaled-up post trial. Following the success of pilot studies of the Australian Fans in Training (Aussie-FIT) programme, a hybrid effectiveness–implementation trial protocol was developed. This protocol outlines methods to: (1) establish if Aussie-FIT is effective at supporting men with or at risk of CVD to sustain improvements in moderate-to-vigorous PA (primary outcome), diet and physical and psychological health and (2) examine the feasibility and utility of implementation strategies to support programme adoption, implementation and sustainment.
Methods and analysis
A pragmatic multistate/territory hybrid type 2 effectiveness–implementation parallel group randomised controlled trial with a 6-month wait list control arm in Australia. 320 men aged 35–75 years with or at risk of CVD will be recruited. Aussie-FIT involves 12 weekly face-to-face sessions including coach-led interactive education workshops and PA delivered in Australian Football League (Western Australia, Northern Territory) and rugby (Queensland) sports club settings. Follow-up measures will be at 3 and 6 months (both groups) and at 12 months to assess maintenance (intervention group only). Implementation outcomes will be reported using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework.
Ethics and dissemination
This multisite study has been approved by the lead ethics committees in the lead site’s jurisdiction, the South Metropolitan Health Service Human Research Ethics Committee (Reference RGS4254) and the West Australian Aboriginal Health Ethics Committee (HREC1221). Findings will be disseminated at academic conferences, peer-reviewed journals and via presentations and reports to stakeholders, including consumers. Findings will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings and populations to benefit men’s health.
Trial registration number
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).
Telemedicine Versus In-Person Primary Care: Treatment and Follow-up Visits
Annals of Internal Medicine, Volume 176, Issue 10, Page 1349-1357, October 2023.
Telemedicine Versus In-Person Primary Care: Treatment and Follow-up Visits
Annals of Internal Medicine, Volume 176, Issue 10, Page 1349-1357, October 2023.