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While you're waiting, a waiting room-based, cardiovascular disease-focused educational program: protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Patients with cardiovascular disease (CVD) frequently attend outpatient clinics and spend a significant amount of time in waiting rooms. Currently, this time is poorly used. This study aims to investigate whether providing CVD and cardiopulmonary resuscitation (CPR) education to waiting patients in a cardiology clinic of a large referral hospital improves motivation to change health behaviours, CPR knowledge, behaviours and clinic satisfaction post clinic, and whether there is any impact on reported CVD lifestyle behaviours or relevant CPR outcomes at 30 days. METHODS AND ANALYSIS:Randomised controlled trial with parallel design to be conducted among 330 patients in the waiting room of a chest pain clinic in a tertiary referral hospital. Intervention (n=220) participants will receive a tablet-delivered series of educational videos catered to self-reported topics of interest (physical activity, blood pressure, diet, medications, smoking and general health) and level of health knowledge. Control (n=110) participants will receive usual care. In a substudy, intervention participants will be randomised 1:1 to receive an extra video on CPR or no extra video. The primary outcome will be the proportion of intervention and control participants who report high motivation to improve physical activity, diet and blood pressure monitoring at end of clinic. The primary outcome of the CPR study will be confidence to perform CPR post clinic. Secondary analysis will examine impact on clinic satisfaction, lifestyle behaviours, CPR knowledge and willingness to perform CPR post clinic and at 30-day follow-up. ETHICS AND DISSEMINATION:Ethics approval has been received from the Western Sydney Local Health District Human Research Ethics Committee. All patients will provide informed consent via a tablet-based eConsent framework. Study results will be disseminated via the usual channels including peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER:ANZCTR12618001725257.

SUBMITTER: Mcintyre D

PROVIDER: S-EPMC7577035 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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While you're waiting, a waiting room-based, cardiovascular disease-focused educational program: protocol for a randomised controlled trial.

Mcintyre Daniel D Thiagalingam Aravinda A Chow Clara C

BMJ open 20201020 10

<h4>Introduction</h4>Patients with cardiovascular disease (CVD) frequently attend outpatient clinics and spend a significant amount of time in waiting rooms. Currently, this time is poorly used. This study aims to investigate whether providing CVD and cardiopulmonary resuscitation (CPR) education to waiting patients in a cardiology clinic of a large referral hospital improves motivation to change health behaviours, CPR knowledge, behaviours and clinic satisfaction post clinic, and whether there ...[more]

PMID: 33082181

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Project description:BACKGROUND:The waiting room in psychiatric services can provide an ideal setting for offering evidence-based psychological interventions that can be delivered through electronic media. Currently, there is no intervention available that have been developed or tested in mental health. AIMS:This proof-of-concept study aimed to evaluate a pilot design of RESOLVE (Relaxation Exercise, SOLving problem and cognitiVe Errors) to test the procedure and obtain outcome data to inform future, definitive trials (trial registration at Clinicaltrials.gov NCT02536924, REB Number: PSIY-477-15). METHOD:Forty participants were enrolled and equally randomised to the intervention, RESOLVE plus treatment as usual arm (TAU), or to a control group (TAU only). Those in the intervention group watched RESOLVE in a room adjacent to the waiting area. Participants in the control received routine care. Outcome measures included the Hospital Anxiety and Depression Scale; the Clinical Outcomes in Routine Evaluations outcome measure; and the World Health Organization Disability Assessment Schedule. These measures were performed by a masked assessor at baseline and at 6-week follow-up. Additionally, we measured the number of contacts with mental health services during the prior 4 weeks. Both intention-to-treat and per protocol analyses were performed. RESULTS:The study proved feasible. We were able to recruit the required number of participants. There was a statistically significant improvement in depression (P < 0.001), anxiety (P < 0.001), general psychopathology (P < 0.001) and disability (P = 0.0361) in favour of the intervention group. People in the intervention group were less likely to contact the service (P = 0.012) post-intervention. CONCLUSIONS:Findings provide preliminary evidence that evidence-based psychosocial interventions can be delivered through electronic media in a waiting-room setting. The outcome data from this study will be used for future definitive trials. DECLARATION OF INTEREST:None.

Project description:IntroductionFewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk. In this project, we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice. Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Islander and non-indigenous adults, recruited through primary care, at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care.Methods and analysisRandomised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk. The trial will be augmented by formal economic and process evaluations to assess acceptability, equity and cost-effectiveness of the intervention. The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management. The programme is electronically integrated with the primary care provider's software and will include interactive smart phone and Internet platforms. The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline-recommended blood pressure (BP) and cholesterol targets. Secondary outcomes include change in mean BP and fasting cholesterol levels, proportion meeting BP and cholesterol targets separately, self-efficacy, health literacy, self-reported point prevalence abstinence in smoking, body mass index and waist circumference, self-reported physical activity and self-reported medication adherence.Ethics and disseminationPrimary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferencesClinical trials registration numberACTRN12613000715774.

Project description:IntroductionAdvances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysisThis paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and disseminationAll procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration numberNCT02925949; Pre-results.

Project description:To assess the level of distress in women awaiting radiologic procedures.In this institutional review board-approved and HIPAA-compliant study, 214 women between 18 and 86 (mean, 47.9) years of age completed the State Trait Anxiety Inventory (STAI), Impact of Events Scale (IES), Center for Epidemiologic Studies Depression Scale (CES-D), and Perceived Stress Scale (PSS) immediately prior to their procedures. One hundred twelve women awaited breast biopsy; 42, hepatic chemoembolization for cancer; and 60, uterine fibroid embolization. Data were analyzed with multivariate analysis of variance and post hoc Tukey tests. Results are reported as means and 95% confidence intervals (CIs).All three patient groups experienced abnormally high mean PSS, IES, and CES-D scores, but only the breast biopsy group had highly abnormal anxiety levels. Breast biopsy patients had a significantly higher mean STAI score of 48 (95% CI: 45, 50) than did women awaiting hepatic chemoembolization (mean score, 26; 95% CI: 22, 29; P < .001) and fibroid embolization (mean score, 24; 95% CI: 21, 27; P < .001). IES ratings did not differ significantly among the groups, with a mean score of 26 (95% CI: 23, 29) for breast biopsy patients, 23 (95% CI: 18, 28) for hepatic chemoembolization patients, and 23 (95% CI: 18, 27) for fibroid embolization patients. The CES-D score did not differ significantly among breast biopsy (mean score, 15; 95% CI: 13, 17), hepatic chemoembolization (mean score, 14; 95% CI: 11, 18), and fibroid embolization (mean score, 12; 95% CI: 9, 15) patients. PSS ratings of breast biopsy patients were significantly higher (mean score, 18; 95% CI: 16, 19) than those of hepatic chemoembolization patients (mean, 15; 95% CI: 13, 17; P < .01), but they were not significantly different from those of women awaiting fibroid embolization (mean, 16; 95% CI: 14, 18; P = .23).Uncertainty of diagnosis can be associated with greater stress than is awaiting more invasive and potentially risky treatment.

Project description:INTRODUCTION:Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS:The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION:This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001288314.

Project description:IntroductionPatient education serves an essential purpose in the long-term management of allergic diseases as a secondary prevention approach. However, evidence on using education for primary prevention is limited. This study aims to evaluate the effect of an educational intervention, that is, the Preventive Antenatal Educational Program on Allergic Diseases (PAEPAD), on infantile allergic disease incidences compared with the standard care.Methods and analysisThis is a single-centre randomised controlled trial of expecting mother-children dyads in Daxing Teaching Hospital of Beijing, China. A total of 2266 expecting mothers will be recruited. Expecting mothers enlisted in the birth registry of Daxing Teaching Hospital of Capital Medical University and intend to give birth at this location will be screened for eligibility. Women aged≥18 years with less than 14+6 weeks of pregnancy who intends to remain resident in Daxing district for at least 2 years postpartum will be entered into the run-in phase. Randomisation will take place at 30 weeks of gestation. Women at high risk for miscarriage or intend to have abortions will be excluded. The participants will be allocated into two groups (ie, the PAEPAD and the standard care group) by random allocation (1:1). The PAEPAD group will receive a multidisciplinary education of neonatal care, including standard education as the control group and additional information on skincare of infants, sun protection, topical corticosteroids and an overview of atopic dermatitis (AD), whereas the standard care group will receive the standard neonatal care education carried out by obstetricians. Participants will be followed for 2 years. The primary outcome will be infantile AD cumulative incidence at 2 years postpartum. Secondary outcomes will include other AD outcomes, atopic march outcomes, knowledge outcomes and other maternal and neonatal outcomes. Data collection will be carried out using both electronic and paper questionnaires. Biological samples will also be collected longitudinally.Ethics and disseminationThe study design was approved by the ethical committee of Capital Medical University Daxing Teaching Hospital, Beijing, China. The trial results will be published in peer-reviewed journals and at conferences.Trial registration numberChiCTR registry (Trial ID: ChiCTR2000040463).

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While you're waiting, a waiting room-based, cardiovascular disease-focused educational program: protocol for a randomised controlled trial.

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While you're waiting, a waiting room-based, cardiovascular disease-focused educational program: protocol for a randomised controlled trial.

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