Usual Care Group Research Articles

Effects of the CALM intervention on cancer-related fatigue and heart rate variability in NSCLC: a randomized trial.

To evaluate the effects of CALM intervention on cancer-related fatigue (CRF), quality of life (QOL), and heart rate variability (HRV) in non-small cell lung cancer (NSCLC) patients. A total of 153 NSCLC patients were enrolled in the study. Participants were randomly assigned to the CALM group and usual care (UC) group. Patients in the CALM group were received 6 CALM intervention sessions over a 12-week period and evaluated using CRF, QOL and HRV at baseline (T0) and after 2, 4, and 6 intervention sessions. The CALM group showed significant differences in total CRF, behavioral/daily life CRF, emotional/affective CRF, sensory/physical CRF, cognitive CRF and QOL before and after CALM intervention sessions (F = 643.47, F = 208.34, F = 354.52, F = 285.69, F = 334.29, F = 245.77, p < 0.001). The CALM group showed significant increases in standard deviation of normal R-R interval (SDNN) and high-frequency power (HF) (z = -4.94, p < 0.001,z = -4.30, p < 0.001). Significant negative correlations were observed between CRF and SDNN, HF and QOL across all participants. The CALM intervention had a positive impact on overall physical and mental health, fatigue reduction, quality of life and autonomic dysfunction in NSCLC patients. Heart rate variability may serve as an observational indicator of physical and mental health.

Evaluating the effects of back massage during labour on delivery outcomes: A prospective study on primigravida mothers

The labor and delivery process can be stressful for parturient women, especially for primigravida mothers. Birth companions providing massage and emotional support can help make more pleasant birthing experience. This study aimed to assess the impact of back massage by trained birth companions on reducing analgesic use, pain intensity scores, and labor duration. The study was conducted on primigravida women. During antenatal care visits, companions in the intervention group were trained in massage techniques, while no training was imparted to companions in the control group. Data were collected using a pre-tested questionnaire during antenatal clinic visits and delivery A multivariable logistic regression model was used to assess the impact of massage on delivery outcomes while adjusting for significant confounding variables.The study demonstrated a positive impact of back massaging on labor and delivery outcomes. Mothers in the massaged group were 2.27 times less likely to receive analgesics and 3.71 times more likely to experience a reduction in pain intensity scores of &amp;#62; 2 compared to those receiving usual care. Additionally, the massaged group had a 2.24 times higher likelihood of reducing labor duration to &amp;#60; 12 hours compared to the usual care group. Back massaging by trained birth companions is an effective intervention for reducing the use of analgesics, pain intensity scores, and the length of labor in primigravida women.

Widely Integrated Services in Home (WISH) for homebound older adults: a study protocol for a randomized encouragement trial.

Home-based primary care (HBPC) is an emerging patient-centered, interprofessional healthcare service model that can address unmet medical needs and care burdens for homebound older adults. In December 2022, the Ministry of Health and Welfare in South Korea launched the Home-Based Medical Center Demonstration project to provide a new bundle payment for physician home visits. In this study, we seek to determine whether the recently introduced HBPC services in South Korea have been associated with a reduction in long-term care (LTC) facility admissions and acute hospitalizations among homebound older adults. The study is a community-based, multicenter, two-arm, randomized encouragement design trial with a 12-month follow-up period (n = 600). Eligible study participants are community-dwelling LTC recipients with multimorbidity and functional deterioration. Study participants are recruited from five HBPC centers located in urban areas (Northeast Seoul, West Seoul, Daejeon, Wonju, and Paju). The study participants are randomly assigned to either the HBPC group or the usual care group with a 1:1 allocation ratio. Those assigned to the HBPC group receive longitudinal home visits at least once a month by an interprofessional HBPC team according to the Widely Integrated Services in Home (WISH) intervention protocol. This protocol adheres to the Integrated Care for Older People principles, which call for a person-centered assessment and broader integration of health and LTC services at the micro-, meso- and macro-levels. Primary outcomes of the trial are 1) between-group community survival days and 2) between-group potentially avoidable hospitalizations. Results of the treatment are estimated by both modified intention-to-treat and complier average causal effect analytic methods. This study aims to investigate the real-world effectiveness of HBPC on the reduction of LTC facility admissions and acute care hospitalizations in the community setting. The findings may inform healthcare policy decisions to expand HBPC services in South Korea and other countries. CRIS KCT0007921.

Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing

OBJECTIVE: To evaluate the effect of an intensive nurse home visiting program on postpartum contraceptive use and birth spacing among individuals with a first pregnancy who were eligible for Medicaid insurance in South Carolina. METHODS: We conducted a nonblinded, randomized controlled trial of the Nurse-Family Partnership (NFP), an established intensive home visiting program that provides prenatal and postpartum home visits through 2 years after childbirth. The trial included patients who were eligible for Medicaid insurance with a first pregnancy at less than 28 weeks of gestation between April 1, 2016, and March 17, 2020, who were followed up through 2 years after childbirth. Participants were randomized 2:1 to NFP compared with standard of care treatment. The primary outcome was a birth interval of less than 21 months between the index pregnancy and a subsequent birth. The secondary outcomes were birth intervals of less than 15 and 24 months, receipt of a contraceptive implant or intrauterine device (IUD) immediately postpartum, any contraceptive use and receipt of a family planning visit (at both 6 weeks and 1 year postpartum), and IUD receipt at 1 year postpartum. We assessed outcomes using linked birth certificate records and Medicaid claims data. RESULTS: A total of 4,932 trial participants (3,295 in the intervention group and 1,637 in the control group) were included in the study analysis. Within 21 months of the study index birth, 11.0% of individuals in the NFP group and 12.2% of the usual care group had a subsequent birth. The NFP did not have a statistically significant effect on birth intervals of less than 21 months (adjusted coefficient −1.1, 95% CI, −2.9 to 0.8). There were no statistically significant differences between the NFP and control groups for any of the study's eight secondary outcomes related to birth spacing and postpartum contraceptive use. CONCLUSION: Home visits with a registered nurse did not affect postpartum contraceptive use or birth spacing. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03360539.

Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer: A Randomized Clinical Trial.

Pediatric patients with cancer commonly experience severely bothersome symptoms. The effectiveness of routine symptom screening with symptom feedback and symptom management care pathways is unknown. To determine whether thrice-weekly symptom screening with symptom feedback and management care pathways, compared with usual care, improves overall self-reported symptom scores measured by the Symptom Screening in Pediatrics Tool (SSPedi) in pediatric patients with cancer. This cluster randomized trial enrolled participants between July 2021 and August 2023 from 20 pediatric cancer centers in the US. Patients newly diagnosed with cancer aged 8 to 18 years receiving any cancer treatment were included. Twenty sites were randomized to provide symptom screening (n = 10) vs usual care (n = 10); 221 participants were enrolled at intervention sites and 224 participants at control sites. The date of final follow-up was October 18, 2023. Symptom screening included providing thrice-weekly symptom screening prompts to participants, email alerts to the health care team, and locally adapted symptom management care pathway implementation. The primary outcome was self-reported total SSPedi score at week 8 (range, 0-60; higher scores indicate more bothersome). Secondary outcomes were Patient-Reported Outcomes Measurement Information System Fatigue score (mean [SD] score, 50 [10]; higher scores indicate more fatigue), Pediatric Quality of Life 3.0 Acute Cancer Module scores (range, 0-100; higher scores indicate better health), symptom documentation and interventions at week 8, and unplanned health care encounters. A total of 445 participants (median [range] age, 14.8 [8.1-18.9] years; 58.9% males) were enrolled. The mean (SD) 8-week SSPedi score was 7.9 (7.2) in the symptom screening group vs 11.4 (8.7) in the usual care group. Symptom screening was associated with significantly better 8-week total SSPedi scores (adjusted mean difference, -3.8 [95% CI, -6.4 to -1.2]) and less bothersome individual symptoms, with 12 of 15 symptoms being statistically significantly reduced. There was no difference in fatigue or quality of life. The mean (SD) number of emergency department visits was 0.77 (1.12) in the symptom screening group and 0.45 (0.81) in the usual care group. There were significantly more emergency department visits in the symptom screening group (rate ratio, 1.72 [95% CI, 1.03-2.87]). Symptom screening with symptom feedback and symptom management care pathways was associated with improved symptom scores and increased symptom-specific interventions. Future work should integrate symptom screening into routine clinical care. ClinicalTrials.gov Identifier: NCT04614662.

The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial

BackgroundDiabetes affects 10.5% of adults globally, with type 2 diabetes accounting for 90–95% of cases. Achieving optimal glycemic control is crucial yet challenging, particularly with insulin therapy, where 30–50% of patients fail to meet treatment targets. Telemedicine can improve diabetes management but generates vast amounts of data, burdening healthcare professionals. Integrating clinical decision support tools into telemonitoring systems may enhance care efficiency and glycemic control.MethodsThe trial is a multicenter 3-month, three-arm, open-label, randomized controlled trial. The trial aims to enroll 51 participants with type 2 diabetes on insulin therapy. Participants will be divided with a 3:1:1 ratio into telemonitoring with decision support, telemonitoring without decision support, and usual care groups. The study employs connected insulin pens, continuous glucose monitors (CGMs), and activity trackers to enable telemonitoring. Outcomes measured include CGM time in range, HbA1c, hypo- and hyperglycemia incidents, total daily insulin dose, body weight, treatment satisfaction, and adherence.DiscussionTelemonitoring with decision support has the potential to revolutionize diabetes management by offering personalized treatment suggestions, thereby reducing the burden on healthcare professionals, and improving patient outcomes. This study will provide valuable insights into the effectiveness of such an approach in achieving glycemic control in people with type 2 diabetes on insulin therapy. By evaluating both clinical outcomes and patient and healthcare professionals’ satisfaction, the study aims to contribute to the development of efficient, scalable telehealth solutions for diabetes care.Trial registrationClinicalTrials.gov NCT06185296. Registered on December 14, 2023.

Effectiveness of smartphone-based music intervention on perinatal depression: protocol for a randomized controlled trial

BackgroundPerinatal depression has become a global public health issue with a high prevalence rate. Multiple studies have confirmed the effectiveness of music intervention. Still, the current form of offline intervention ignores issues such as convenient transportation and the stigma of diseases that pregnant women are concerned about, resulting in poor adherence. This randomized controlled study will evaluate the impact of music intervention on depression, anxiety, and stress in perinatal women through the WeChat application. In addition, the usability of the WeChat application and the adherence of PND women will also be evaluated.MethodsThis randomized, open, single-center parallel controlled trial randomly divided 110 women with perinatal depression who met the inclusion criteria into a smartphone-based music intervention group and usual care group in a 1:1 ratio. The main outcome measures will consist of EPDS and WeChat application usability score. The secondary outcome measures will consist of GAD-7, CPSS, and Knowledge-Attitude-Practice questionnaire scores.DiscussionThis study will test the effectiveness of music intervention based on the WeChat application for perinatal depression and the usability of the WeChat application, to provide practical guidance for perinatal mental health care.Trial RegistrationThis protocol was registered at the Chinese Clinical Trials.gov (Identifier: ChiCTR2400088924) on August 29, 2024.

Yoga-based lifestyle intervention for antenatal depression (YOGA-D): study protocol for a pilot randomized controlled trial

Background Depression during pregnancy is associated with pre-term labor, low birthweight, post-partum depression and adverse child outcomes. There are concerns about the safety of anti-depressant medications during pregnancy. Many pregnant women with antenatal depression are neither aware about their depression nor do they have access to non-pharmacological interventions for depression. Evidence suggests that pre-natal yoga can improve antenatal depression. Yoga is native to the Indian culture and women can practice yoga as a ‘self-care’ intervention with minimal training. There is no study till date on the efficacy of yoga on antenatal depression in pregnant women in a low resource (rural) setting in India. This pilot randomized controlled trial aims to study the feasibility, acceptability, and preliminary efficacy of a YOGA -based lifestyle intervention for Antenatal D epression (YOGA-D) in Maharashtra, India. Methods We will undertake a single-blind individual randomized parallel group-controlled pilot trial with 1:1 allocation ratio. Adult women with 12–26 weeks of pregnancy, without any obstetric or medical complications will be randomly allocated to either the active intervention group (Yoga-Sanskar (YS)) or the Enhanced Usual Care (EUC) group. Trained yoga instructors will teach a pre-defined yoga sequence to the participants in the YS arm. In the EUC arm, participants will receive a single session of health education. We will assess trial feasibility using the recruitment, retention, and study completion rates. The primary outcome of depression will be measured using the translated Marathi version of the Patient Health Questionnaire-9. Assessments will be at the baseline, three-months post-randomization, and post-delivery. Discussion This study will help us to understand the barriers in implementation of a yoga-based intervention for antenatal depression in a low-resource/rural setting in Maharashtra, India. Based on the learnings of this pilot trial, we plan to undertake an explanatory randomized controlled trial in the next few months. Registration CTRI (CTRI/2024/05/067176; 10/05/2024).

Cost-effectiveness and cost-utility analysis of a nurse-led, transitional care model to improve care coordination for patients with cardiovascular diseases: results from the "Cardiolotse" study.

To assess the 12-month cost-effectiveness of the nurse-led transitional care program "Cardiolotse" (CL) for patients with cardiovascular diseases compared to usual care (UC). A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) were conducted from the perspective of statutory health insurance (SHI), covering a time horizon of 12 months. Analyzed outcomes included the number of rehospitalizations and health-related quality of life (HRQoL). Total costs comprised program costs and the utilization of healthcare resources. Point estimates are presented as incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs). Sensitivity and subgroup analyses were conducted to illustrate uncertainty and provide insights into the impact mechanisms of the CL program. The study population consisted of 2550 patients, with 1256 allocated to the intervention group and 1294 to the control group. Patients who received support from CLs experienced fewer rehospitalizations and lower inpatient costs from an SHI perspective, compared to the UC group. HRQoL assessments indicated higher utility values for CL patients at the 12-month follow-up. Total program costs amounted to €1454.65 per patient. The CEA and CUA demonstrate that the CL program is dominant compared to UC from the SHI perspective. Our study shows that the CL program not only reduces the number of rehospitalizations and costs but increases HRQoL, resulting in a dominant ICER and ICUR. Further research is necessary to evaluate longer periods of time, different levels of care intensity, and perspectives of different healthcare stakeholders. German Clinical Trial Register DRKS00020424, 2020-06-18, retrospectively registered.

Efficacy of a WeChat-Based, Multidisciplinary, Full-Course Nutritional Management Program on the Nutritional Status of Patients With Ovarian Cancer Undergoing Chemotherapy: Randomized Controlled Trial.

As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for patients with OC, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage patients with OC in the intervals between chemotherapy. The use of WeChat, an effective mobile tool, in chronic disease management has been highlighted. This study aimed to implement a continuous follow-up strategy and health monitoring based on the WeChat platform for patients with OC undergoing chemotherapy to ensure that each phase of chemotherapy was delivered on schedule and to improve the survival rate of patients with OC. Participants were recruited and randomly assigned to either the WeChat-based nutrition intervention group or the usual care group. A self-administered general information questionnaire was used at enrollment to obtain basic information about the patients. The Patient-Generated Subjective Global Assessment (PG-SGA) Scale was used to investigate the nutritional status of the patients at 3 time points (T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy). The blood indices of patients were investigated through the inhospital health care system at 3 times（T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy). Patients in the intervention group were introduced to the nutrition applet, invited to join the nutrition management group chat, and allowed to consult on nutritional issues in private chats with nutrition management team members. Linear mixed models were used to analyze changes in each nutritional indicator in the 2 groups, with their baseline measurements as covariates; with group, time, and group-time interactions considered as fixed effects; and with patients considered as random effects. A total of 96 patients with OC undergoing chemotherapy were recruited into the study. Distribution was based on a 1:1 ratio, with 48 patients each in the nutrition intervention group and the usual care group. The attrition rate after the first chemotherapy session was 18.75%. The mixed linear model revealed that the group-based effect and the group-time interaction effect on PG-SGA scores were significant (F38,38=4.763, P=.03; F37,37=6.368, P=.01), whereas the time-based effect on PG-SGA scores was not (F38,38=0.377; P=.54). The findings indicated that the group-based effect, the time-based effect, and the group-time interaction effect on nutrition-inflammation composite indices were significant (F38,38=7.653, P=.006; F38,38=13.309, P<.001; F37,37=92.304, P<.001; F37,38=110.675, P<.001; F38,38=10.379, P=.002; and F37,37=5.289, P=.02). This study provided evidence that a WeChat-based, multidisciplinary, full-course nutritional management program can significantly improve the nutritional status of patients with OC during chemotherapy.

Nurse‐Led Screening‐Triggered Early Specialized Palliative Care Program for Patients With Advanced Lung Cancer: A Multicenter Randomized Controlled Trial

ABSTRACTBackgroundWe aimed to examine the effectiveness of a nurse‐led, screening‐triggered early specialized palliative care intervention program for patients with advanced lung cancer.MethodsPatients with advanced lung cancer who underwent initial chemotherapy were randomized to intervention and usual care groups between January 2017 and September 2019. The intervention comprised comprehensive needs assessments, counseling, and service coordination by advanced‐level nurses. Patients in the usual care group received the usual oncological care. The primary end point was a change in the trial outcome index (TOI) scores from baseline to 12 weeks. The secondary end‐points were TOI scores at week 20, depression, anxiety, and survival.ResultsIn total, 102 patients were assigned to each group. Compared with the usual care group, no significant improvement in TOI scores was observed at 12 weeks in the intervention group (mean group difference: 2.13; 90% confidence interval: −0.70, 4.95; p = 0.107, one‐sided), whereas significant improvement was observed at 20 weeks (3.58; 90% confidence interval: 0.15, 7.00; p = 0.043). There were no significant differences in the change from baseline depression and anxiety between the groups from baseline at week 12 and 20 weeks (depression: p = 0.60 and 0.10, anxiety: p = 0.78 and 0.067). Survival did not significantly differ between the groups (median survival time: 12.1 vs. 11.1 months; p = 0.302).ConclusionsNurse‐led, screening‐triggered, early specialized palliative care did not show significant superiority over usual care during the 12‐week study period. However, it may have yielded delayed clinical benefits, such as improved quality of life and this feasible model can be acceptable in clinical practice.Trial Registration: The University Hospital Medical Information Network Clinical Trials Registry: UMIN000025491

Effect of a home-based exercise program on subsequent falls among community-dwelling older adults with cognitive frailty: A sub-group analysis of a randomized controlled trial

ObjectivesCognitive frailty is characterized by concurrent physical frailty and mild cognitive impairment and is associated with increased risk of falls. Exercise is an evidence-based strategy to prevent falls, but whether exercise reduces falls in people with cognitive frailty is unknown. We examined the effects of home-based exercise on subsequent falls among community-dwelling older adults with cognitive frailty who have previously fallen. Study designA sub-group analysis of a 12-month, single-blind, randomized controlled trial among 344 adults aged 70 years or more who had fallen within the past 12 months. Participants were randomized to either 12 months of home-based exercise (n = 172) or usual care (n = 172). In this sub-analysis, we included 192 participants with cognitive frailty (home-based exercise = 93; usual care = 99) with Short Physical Performance Battery scores ≤9/12 and Montreal Cognitive Assessment scores <26/30. Main outcome measuresOur primary analysis examined the effect of exercise on self-reported falls rate over 12 months. Secondary analyses investigated the intervention's effects on scores on the Short Physical Performance Battery and the Montreal Cognitive Assessment. We also explored whether greater than or equal to mean average monthly adherence (i.e., ≥45.5 %) moderated treatment effects. ResultsAt 12 months, falls rates were 35 % lower in the home-based exercise group compared with the usual care group (IRR = 0.65; p = 0.042). Score on the Short Physical Performance Battery significantly improved among home-based exercise participants with greater than or equal to mean adherence vs. those with less than mean adherence (estimated mean difference: 0.94; p = 0.022). ConclusionsExercise is a promising strategy for reducing subsequent falls in people with cognitive frailty. Greater exercise adherence improved physical function in this population.ClinicalTrials.gov identifier: NCT01029171

Strategies to Limit Benzodiazepine Use in Anesthesia for Older Adults

Despite guidelines recommending avoidance of benzodiazepine administration to older patients, many of them now receive benzodiazepines as a part of anesthesia care. The effectiveness of clinician- and patient-facing interventions to discourage such use remains insufficiently characterized. To evaluate the effect of clinician peer comparison, patient informational mail, or a combination of these interventions compared with usual care on the rate of perioperative benzodiazepine administration to older patients. This 2 × 2 factorial, stepped-wedge, cluster randomized clinical trial of a corporate quality improvement initiative was conducted between August 8, 2022, and May 28, 2023, across 415 hospitals, surgery centers, and physician offices in 8 US states served by anesthesia clinicians from a national anesthesia practice. Participants were adults aged 65 years or older who underwent an elective surgical or endoscopic procedure with general anesthesia. Data analyses followed the intention-to-treat principle. Patients were randomly assigned to 1 of 4 groups-clinician peer comparison (wherein clinicians received feedback regarding their performance compared with other clinicians in the practice), patient informational mail (wherein patients received an informational letter encouraging them to have a discussion regarding medication selection with their clinician on the day of surgery), both interventions, or usual care (no intervention). Rate of benzodiazepine administration during anesthesia care and patient satisfaction with anesthesia care (measured by the Anesthesia Patient Satisfaction Questionnaire, version 2). Among the 509 269 enrolled participants (255 871 females [50.2%]; mean [SD] age, 74 [7] years), 81 363 (16.0%) were assigned to clinician peer comparison, 98 520 (19.3%) to patient informational mail, 169 712 (33.3%) to both interventions, and 159 674 (31.4%) to usual care. Among patients who received benzodiazepine during anesthesia care, 24.5% were in the usual care group compared with 19.7% in the clinician peer comparison group, 20.0% in the patient informational mail group, and 19.7% in the combination group. After adjustment for time, none of the study interventions were associated with lower odds of benzodiazepine administration compared with usual care (odds ratio [OR], 1.02 [95% CI, 0.98-1.07]; P = .35 for clinician peer comparison; OR, 1.01 [95% CI, 0.96-1.05]; P = .81 for patient informational mail; and OR, 1.11 [95% CI, 1.05-1.16]; P < .001 for combined interventions). Satisfaction scores were high in all groups and did not vary by treatment assignment. This randomized clinical trial found that clinician peer comparison, patient informational mail, or a combination of both interventions did not reduce benzodiazepine administration to older patients compared with usual care; patient satisfaction remained high throughout the study. Overall, the findings suggest a need to explore other patient-targeted interventions to improve anesthesia care. Clinicaltrials.gov Identifier: NCT05436392.

Patient-initiated follow-up supported by asynchronous telemedicine versus usual care in spondyloarthritis (TeleSpA-study): a randomised controlled trial of clinical and cost-effectiveness.

With rising health-care expenditures and workforce shortages, sustainable alternatives to traditional outpatient follow-up strategies are required to optimise care efficiency. We aimed to investigate the cost-effectiveness and clinical effectiveness of patient-initiated follow-up (PIFU) supported by asynchronous telemedicine for patients with spondyloarthritis compared with usual care in daily practice. TeleSpA was a multicentre, pragmatic, open-label, randomised controlled trial. Patients with spondyloarthritis and stable disease were randomly assigned (1:1) to either the PIFU and asynchronous telemedicine group or usual care group. All patients received a scheduled outpatient visit at baseline and after 1 year. Patients were monitored remotely at 6 months (PIFU and asynchronous telemedicine) or at the discretion of the treating rheumatologist (usual care). The primary outcome was the number of rheumatology visits within a 1-year period. A trial-based 1-year health-economic evaluation from a Dutch health-care perspective (only including health-care costs) and societal perspective (also including travel costs and work productivity losses), per the Dutch guidelines was used to estimate cost-effectiveness. The safety analysis was done in the intention-to-treat population and was based on spontaneous reports of adverse events and serious adverse events or as observed by the research team. The primary analysis was in the intention-to-treat population. Individuals with relevant lived experience were involved in the study design. This trial was registered with the Dutch National Trial Register (NL71041.068.19) and ClinicalTrials.gov (NCT04673825) and is completed. Between Dec 2, 2020, and June 20, 2022, 200 patients were randomly assigned to PIFU and asynchronous telemedicine (n=100) or usual care (n=100). 79 (40%) of 200 participants were women, 121 (60%) were men, and the mean age was 55·0 years (SD 11·9). After 1 year, the mean number of rheumatology visits was 1·9 (SD 1·5) for the PIFU and asynchronous telemedicine group and 2·6 (1·3) in the usual care group (mean difference -0·7 [95% CI -1·0 to -0·3]; 25·4% reduction; p<0·0001). PIFU and asynchronous telemedicine was cost-effective from a health-care perspective, saving health-care costs (-€180 [95% CI -921 to 560]) without a loss in quality-adjusted life-years (0·004 [95 % CI -0·022 to 0·030]). Seven non-trial-related adverse events occurred in the PIFU and asynchronous telemedicine group and eight in usual care group (including one death). PIFU and asynchronous telemedicine resulted in significant and clinically meaningful reductions in rheumatology visits. This was not at the expense of health outcomes and saved health-care costs. Dutch Arthritis Society.

Functional echocardiography for management of shock in neonates - study protocol for a randomized controlled trial

Background: Shock is common in sick neonates and is associated with a high mortality. Detection and management of shock by monitoring clinical parameters may be inadequate due to inconsistent association with tissue perfusion. We hypothesize that objective assessments of cardiac functions may help to match the pathophysiology of shock with the pharmacological action of a vasoactive drug. This may lead to earlier resolution of shock and reduced incidence of mortality or brain injury. To test this hypothesis, this study aims to evaluate the efficacy of adding functional echocardiography to standard clinical assessment in improving short-term outcome of neonates with clinical features of shock. Methods: This study will be an open-labeled randomized controlled trial, conducted in all inborn neonates born at &gt;27 weeks of gestation who develop clinical signs of shock. Enrolled neonates will be randomized into two groups: the echo group and the control group. Neonates in the echo group will be assessed for management of shock by both standard clinical evaluation and functional echocardiography. Neonates in the control group will be assessed for the management of shock by standard clinical evaluation. Primary outcome will be survival without requirement of inotropic support at 72 hours of randomization. Secondary outcomes include time to hemodynamic stability, duration of inotropic support and incidence of abnormal cranial ultrasound. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p&lt;0.001). Conclusions: The trial intends to deduce the advantages, if any, of addition of functional echocardiography to standard clinical assessment to guide management of shock among preterm and term neonates. Trial registration: CTRI number: CTRI/2023/08/056672.

A Tailored Postpartum eHealth Physical Activity Intervention for Individuals at High Risk of Postpartum Depression-the POstpartum Wellness Study (POW): Protocol and Data Overview for a Randomized Controlled Trial.

Postpartum depression (PPD) is associated with significant health consequences for the parent and child. Current recommendations for PPD prevention require intense health care system resources. Evidence-based interventions for PPD prevention that do not further burden the health care system are needed. Evidence suggests that physical activity (PA) can generally reduce depressive symptoms. Technology-based interventions may help decrease common barriers to PA. This study aims to report the protocol and provide a data overview of the POstpartum Wellness study (POW)-an effectiveness trial evaluating whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among individuals at high PPD risk. This remote parallel-group randomized controlled trial included postpartum individuals with a history of depression or at least moderate current depressive symptoms not meeting the PPD diagnostic threshold and with low PA levels from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The intervention group received access to a library of web-based workout videos designed for postpartum individuals, which included interaction with their infants. At baseline and follow-up (3 and 6 months), PA was measured using questionnaires and a wrist-worn accelerometer. Depressive symptoms were measured using the Patient Health Questionnaire-8 (PHQ-8). Data were collected to assess exploratory outcomes of sleep, perceived stress, anxiety, parent-infant bonding, and infant development. The study was funded in January 2020. Participants were enrolled via REDCap (Research Electronic Data Capture) or telephonically between November 2020 and September 2022; data collection ended in April 2023. Randomized participants (N=99) were 4 months post partum at baseline with moderately severe depressive symptoms (mean PHQ-8 score 12.6, SD 2.2). Intervention (n=50) and usual care (n=49) groups had similar sociodemographic characteristics, months post partum, baseline depressive symptoms, number of children at home, and prepregnancy PA levels. Retention in assessments was ≥66% for questionnaires and ≥48% for accelerometry, with modest differences by group. At 3-month follow-up, 73 of 99 (74%) participants (intervention: 35/50, 70%; usual care: 38/49, 78%) completed questionnaires; 53 of 99 (54%) wore the accelerometer for 7 days (27 of 50 (54%) intervention, 26 of 49 (53%) usual care). At 6-month follow-up, 66 of 99 (67%) participants (30 of 50 (60%) intervention, 36 of 49 (73%) usual care) completed questionnaires and 43 of 99 (43%) wore the accelerometer for 7 days (21 of 50 (42%) intervention, 22 of 49 (45%) usual care). Data analysis is completed, and a manuscript with these findings is currently under review for publication. The POW trial evaluates the effectiveness of an eHealth PA intervention for improving depressive symptoms and increasing PA among postpartum individuals at high PPD risk. Results have implications for the design and delivery of behavioral interventions among vulnerable patients. ClinicalTrials.gov NCT04414696; https://clinicaltrials.gov/ct2/show/NCT04414696. DERR1-10.2196/56882.

Factors influencing low-density-lipoprotein cholesterol after acute coronary syndrome and effectiveness of intensive teleconsultation monitoring, the teleobjectif cohort study

Abstract Context: Low-density lipoprotein cholesterol (LDL-c) plays a key role in the development and progression of atherosclerotic cardiovascular disease (ASCVD). Despite the availability of effective lipid-lowering treatments, patients who have experienced an acute coronary syndrome (ACS) continue to face a high risk of recurrent cardiovascular events and mortality. Achieving the recommended LDL-c target of &amp;lt;0.55 g/L in secondary cardiovascular prevention remains a significant challenge, with fewer than 30% of patients reaching this goal. Aim To investigate the factors influencing LDL-c control after ACS and the effectiveness of intensive teleconsultation monitoring to control LDL-c, even in sub-groups where control is poorest. Methods This bi-centric prospective cohort study conducted between december 2019 and december 2021 compared a group that received standard follow-up after an ACS with an interventional group that received regular follow-up by teleconsultation in addition of usual care to optimize lipid-lowering treatment. A subgroup analysis was carried out to examine the effect of teleconsultation in subpopulations known to be significantly associated with better or worse LDL-c control in the usual care group or described in the literature. Results 1602 patients met the inclusion criteria for our study (814 in the usual care group and 788 in the teleconsultation group). Baseline characteristics were similar between groups. In the usual care group, factors influencing lipid control included gender, diabetes, cardiology consultation, distance to the nearest cardiologist, social deprivation and initial LDL-C levels. Teleconsultation significantly improved LDL-C target attainment compared to usual care (74.7% vs. 26.6%, p&amp;lt;0.001 with multivariate analysis OR 5.06 [4.21 ; 6.07]), particularly benefiting geographically and socially disadvantaged patients. Conclusion Teleconsultation significantly improves lipid control in acute coronary syndrome patients compared to usual care. This universal intervention, particularly beneficial for geographically and socially disadvantaged patients, highlights the potential of telemedicine in enhancing cardiovascular management.analysis in usual care groupTeleconsultation effect in sub-groups

Impact of teleconsultation follow-up to control low-density-lipoprotein cholesterol at one year after acute coronary syndrome: the teleobjectif prospective cohort study

Abstract Context High level of low-density lipoprotein cholesterol (LDL-c) is one of the most important causal and independent risk factor for recurrent atheromatous cardiovascular events. Despite the availability of several treatments that can reduce LDL-c by up to 85%, less than 30% of patients achieve the LDL-c target &amp;lt; 0.55 g/dl, recommended by the European Society of Cardiology for secondary cardiovascular prevention. Aim We hypothesized that teleconsultation monitoring would allow better control of LDL-c blood levels at one year in a population after acute coronary syndrom (ACS). Methods This bi-centric prospective cohort study, conducted between december 2019 and december 2021, compared a group that received standard follow-up after an ACS with an interventional group that received regular follow-up by teleconsultation, in addition of usual care, to optimise lipid-lowering treatments. Results 1602 patients met the inclusion criteria for our study (814 in the usual care group and 788 in the teleconsultation group). The proportion of patients with LDL-c &amp;lt; 0.55 g/L at one year was statistically significant in the teleconsultation group (74.7%) compared with the usual care group (26.6%) (p&amp;lt;0.001). The average (standard deviation) absolute value of LDL-c at 1 year was 0.48 g/L (0.2) in the teleconsultation group and 0.75 g/L (0.32) in the usual care group (p&amp;lt;0.001). In the multivariate analysis, receiving teleconsultation follow-up made it more likely to achieve the LDL-c target (4.88 [4,09 ; 5,85], p&amp;lt;0.001). The use of lipid-lowering treatments, including statins, ezetimibe and anti-PCSK9 inhibitors was much higher in the teleconsultation group (p&amp;lt;0.001). There was a significant difference in overall survival (p=0.016) and cardiovascular survival (p=0.013) in favor of the teleconsultation group. Conclusion teleconsultation follow-up after ACS significantly improved lipid control and survival at one year.% patients achieving 1-year LDL-c targetOverall survival

Early rhythm control of atrial fibrillation in cancer survivors: a nationwide population-based cohort study

Abstract Background Though early rhythm control (ERC) in patients with atrial fibrillation (AF) is effective in reducing stroke, the benefit of ERC has not been well-elucidated in cancer survivors. This study aimed to compare the risk of ischemic stroke between ERC and usual care in cancer survivors with AF and cancer. Methods This nationwide observational study was conducted using the Korean National Health Insurance Service database. Patients aged 20 years or older with newly diagnosed AF between 2009 and 2018 were included. Patients who received rhythm control therapy within 1-year of AF diagnosis were defined as the ERC group, while the remaining patients were defined as the usual care group. The risk of ischemic stroke in the ERC group compared to the usual care group was evaluated in long-term cancer survivors (cancer diagnosis ≥5 years) and the non-cancer group. Results A total of 591,692 patients were included in the study (18,747 patients [3.2 %] with cancer, mean age 65.7±14.6 years, 53.7% men, mean CHA2DS2-VASc score 3.3±2.0). The proportion of patients receiving ERC was slightly higher in cancer survivors compared to the non-cancer group (28.0% vs 25.3%, p&amp;lt;0.001). During a mean 4-year follow-up, incident stroke occurred in 52,500 patients (1,338 in cancer survivors, 51,182 in non-cancer). The ERC group showed a lower risk of stroke than the usual care group, regardless of the presence of cancer history(Figure); adjusted hazard ratio [95% confidence interval] 0.67 [0.58-0.76] in cancer survivors, 0.76 [0.74-0.78] in the non-cancer group (p-for-interaction=0.125). The effect of ERC on the risk of ischemic stroke in cancer group was consistent across all subgroups, including different cancer types or use of chemotherapy. Conclusion ERC was associated with a lower risk of ischemic stroke among long-term cancer survivors. An integrated approach incorporating appropriate rhythm control strategies should be considered for cancer survivors with newly diagnosed AF.

Effectiveness of hybrid comprehensive telerehabilitation in women with heart failure - subanalysis of the TELEREH-HF RCT

Abstract Background Despite the known benefits of cardiac rehabilitation, it remains underutilized among women. In particular, little is known about the effectiveness of hybrid comprehensive telerehabilitation (HCTR) in women with heart failure (HF). Purpose: The purpose of this study was to assess effectiveness and safety of HCTR in women with HF. Methods: The present analysis formed part of TELEREH-HF multicenter, randomized trial that enrolled 850 HF patients (NYHA I-III, LVEF ≤ 40%). Patients were randomized 1:1 to HCTR plus usual care (UC) or UC alone. Patients underwent either an HCTR (1 week in hospital and 8 weeks at home, five times weekly) or UC with observation. The effectiveness of HCTR was assessed by changes in peak oxygen consumption (VO2 peak), workload duration (t) in cardiopulmonary exercise test and quality of life (QoL) based on Medical Outcome Survey Short Form 36 Questionnaire (SF-36). Measurements were made before and after intervention/observation. Results: Women constituted 11.5 % of population in the TELEREH-HF study. Forty women in HCTR group and 44 women in UC group completed HCTR and observation respectively. HCTR resulted in significant improvement in VO2peak, workload duration and QoL. We did not observe these favorable results in the UC group except for an increase workload duration. In the HCTR group, there was a significantly greater improvement in physical component of QoL than in the UC group. All results are presented in Table 1. In neither group were there deaths nor major adverse events related to exercise training. Conclusion In women with HF, hybrid comprehensive telerehabilitation is safe and resulted in a significant improvement in physical capacity and QoL.