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Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery. OBJECTIVE:This manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity. METHODS:This pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start. RESULTS:Recruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing. CONCLUSIONS:The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician. TRIAL REGISTRATION:ClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/18891.

SUBMITTER: Rockette-Wagner B

PROVIDER: S-EPMC7671848 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial.

Rockette-Wagner Bonny B Fischer Gary S GS Kriska Andrea M AM Conroy Molly B MB Dunstan David D Roumpz Caroline C McTigue Kathleen M KM

JMIR research protocols 20201103 11

<h4>Background</h4>Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, t ...[more]

PMID: 33141103

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Project description:Background: Physical activity (PA) interventions are limited in number and reach for youth with physical disabilities (YPD) who experience systemic barriers that may preclude their in-person participation. Further, a lack of theory in the development and evaluation of PA interventions impedes our understanding and replication of active components of behavior change. These limitations pose challenges in the effective promotion of PA in YPD. Theory-based and more inclusive methods of PA intervention delivery must be explored in our efforts to promote PA and overall health in YPD. Methods: A pilot study was conducted to evaluate the feasibility and outcomes of an online, 4-week social cognitive theory-based PA intervention for YPD. Intervention feasibility (implementation fidelity, intervention compliance, and intervention acceptability) was evaluated through manual documentation, weekly feedback questionnaires, and open-ended feedback at 1-month post-intervention. Targeted social cognitive (outcome expectations, self-efficacy [task, self-regulatory, barrier] and self-regulation) and PA behavior outcomes were self-reported at baseline and 1-week and 1-month post-intervention. Results: Sixteen YPD (Mage = 17.4 ± 2.7 years, 69% female) completed the study. Intervention feasibility was supported by high implementation fidelity (100%), high intervention compliance (>90%), and positive ratings on indicators of acceptability for all weeks of the intervention (weekly feedback questionnaire means ranging from 5.74 to 6.19 out of 7). Through open-ended feedback, participants indicated the intervention was easy to use and understand, favorably shifted their self-awareness and personal meaning of PA, and provided value and potential for future use pertaining to the learned self-regulation skills and strategies. Participants also provided formatting and content recommendations for intervention improvement. Repeated measures ANOVAs showed significant and large effect sizes for changes in participants' task (p = 0.01, n 2 p = 0.28) and barrier (p = 0.02, n 2 p = 0.24) self-efficacy, goal-setting and planning and scheduling behaviors (ps < 0.001, n 2 ps = 0.42), and self-reported PA behavior (p = 0.02, n 2 p = 0.26). Conclusions: An online PA intervention for YPD is feasible and may offer potential benefit through the enhancement of self-efficacy, self-regulation, and PA behavior. Continued research is necessary to understand the efficacy and longer-term outcomes of online, theory-based interventions for YPD as a PA promotion strategy.

Project description:Background and objectivesThe number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care, and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes and pregnancy outcomes and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases.Methods/designThis two-arm parallel group RCT will be conducted from October 2018 through June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: (1) coordinated and individualized care, (2) additional ante- and postpartum consultations, and (3) specialized midwives. The primary outcome is length of hospital stay during pregnancy and in the postpartum period, and secondary outcomes are psychological well-being (five-item World Health Organization Well-Being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (12-Item Short Form Health Survey), patient satisfaction (Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data are collected via patient-administered questionnaires and medical records.DiscussionThis trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded.Trial registrationClinicalTrials.gov, NCT03511508 . Registered April 27, 2018.

Project description:BackgroundDeficits in general and specialized on-site medical care are a common problem in nursing homes and can lead to unnecessary, costly and burdensome hospitalizations for residents. Reasons for this are often organizational obstacles (such as lack of infrastructure or communication channels) and unfavorable compensation structures, which impede the implementation of adequate medical care. The purpose of this study is to evaluate a complex intervention aiming to improve the coordination of medical care in long-term care nursing homes in Germany. The project aims to optimize the collaboration of nurses and physicians in order to reduce avoidable hospital admissions and ambulance transportations.Methods/designIn a prospective controlled trial, nursing home residents receiving a complex on-site intervention are compared to residents receiving care/treatment as usual. The study will include a total of around 4000 residents in approximately 80 nursing homes split equally between the intervention group and the control group. Recruitment will take place in all administrative districts of Baden-Wuerttemberg, Germany. The control group focuses on the administrative district of Tuebingen. The intervention includes on-site visits by physicians joined by nursing staff, the formation of teams of physicians, a computerized documentation system (CoCare Cockpit), joint trainings and audits, the introduction of structured treatment paths and after-hours availability of medical care. The project evaluation will be comprised of both a formative process evaluation and a summative evaluation.DiscussionThis study will provide evidence regarding the efficacy of a complex intervention to positively influence the quality of medical care and supply efficiency as well as provide cost-saving effects. Its feasibility will be evaluated in a controlled inter-regional design.Trial registrationWHO UTN: U1111-1196-6611 ; DRKS-ID: DRKS00012703 (Date of Registration in DRKS: 2017/08/23).

Project description:BackgroundBlack women experience a higher prevalence of poor asthma outcomes and physical inactivity than their White counterparts. Black women comprise a particularly vulnerable group of patients with asthma, with some of the highest rates of asthma in adults, high health care use (emergency department visits and hospitalizations), and the highest crude asthma mortality rate of all race or ethnicity groups. Despite recommendations to engage in regular physical activity, fewer than 15% of Black women meet the 2008 National Physical Activity Guidelines, the lowest of all racial subgroups of adults. Given the connection between physical inactivity and poor asthma outcomes, addressing physical activity among Black women with asthma is imperative.ObjectiveThis 2-arm randomized controlled trial aims to (1) determine the efficacy of a lifestyle walking intervention on asthma control compared to an education (control) group over 24 weeks, (2) examine the maintenance effects of the lifestyle walking intervention on asthma control at 48 weeks, (3) explore the behavioral mediators (eg, self-efficacy, social support, self-regulation, and daily physical activity levels) and contextual moderators (eg, baseline asthma severity, neighborhood environment, comorbid conditions, and social determinants of health) that contribute to treatment responsiveness, and (4) assess the reach and implementation potential of the intervention.MethodsThe proposed study (ACTION [A Lifestyle Physical Activity Intervention for Minority Women with Asthma]) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through 2 urban health care systems that care for a diverse Black population. Patients will be randomized to one of two groups: (1) ACTION intervention (group sessions, physical activity self-monitoring-Fitbit, and text-based support for step goal setting) or (2) education control (an individual asthma education session and SMS text messages related to asthma education). Outcome assessments will take place at baseline, 12, 24, and 48 weeks. The primary outcome is a change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, health care use, and asthma exacerbations and behavioral outcomes such as self-efficacy, self-regulation, social support, and physical activity.ResultsThis study was funded by the National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023, with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027.ConclusionsThis study will deliver a new approach to physical activity interventions in Black women with asthma and help to provide guidance for addressing physical activity within this subgroup. This study will also provide a potential framework for future studies in minoritized populations with other disease conditions associated with low levels of physical activity.Trial registrationClinicalTrials.gov NCT05726487; https://clinicaltrials.gov/study/NCT05726487.International registered report identifier (irrid)DERR1-10.2196/55700.

Project description:BackgroundWomen with perinatal depression and their children are at increased risk of poor health outcomes. There is a need to implement non-stigmatizing interventions into existing health systems which reduce psychosocial distress during pregnancy and prevent perinatal depression. We adapted the WHO-endorsed Thinking Healthy Programme (THP) to be delivered universally to all women attending routine online pregnancy schools in Istanbul, Turkey. This study aimed to evaluate the feasibility and acceptability of this intervention.MethodsThis mixed-methods study incorporated a two-arm pilot randomized controlled trial and qualitative evaluation of the feasibility and acceptability of the adapted THP - Brief Group version (THP-BGV) to a range of stakeholders. We recruited pregnant women at 12-30 weeks' gestation through pregnancy schools within the University Hospital's catchment area. Women in the intervention arm received five online sessions of the THP-BGV delivered by antenatal nurses. The intervention employed principles of cognitive behaviour therapy to provide psychoeducation, behaviour activation, problem-solving strategies and group support to participants. In the control arm, women received usual care consisting of routine online educational pregnancy classes aided by the antenatal nurses. The women were assessed for depressive symptoms with the Edinburgh Postnatal Depression Scale at baseline and 4-6 weeks post-intervention and also evaluated for anxiety, perceived social support, partner relationship, level of disability and sleep quality. In-depth interviews were conducted with women and other key stakeholders.ResultsOf the 99 consecutive women referred to the pregnancy schools, 91 (91.9%) were eligible and 88 (88.8%) consented to participate in the study and were randomized. Eighty-two (83%) completed the final assessments. Our main findings were that this preventive group intervention was feasible to be integrated into routine antenatal educational classes and it was valued by the women and delivery-agents. While the study was not powered to detect differences between intervention and control conditions, we found small trends towards reduction in anxiety and depressive symptoms favoring the intervention arm. No serious adverse events were reported.ConclusionsGiven the paucity of preventive interventions for perinatal depression in low and middle-income countries, a fully powered definitive randomized controlled trial of this feasible and acceptable intervention should be conducted.Trial registrationThe study was registered at Clinical Trails.gov ( NCT04819711 ) (Registration Date: 29/03/2021).

Project description:BackgroundMy Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds.ObjectiveThis study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy).MethodsWe are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians).ResultsThis study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment.ConclusionsThis randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points.Trial registrationClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333.International registered report identifier (irrid)DERR1-10.2196/25955.

Project description:BackgroundUntreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH.MethodsA two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population.DiscussionThis trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial.Trial registrationISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.

Project description:IntroductionPredialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education-COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status.Methods and analysisThis is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ?70 years and/or poor functional status (as defined by Karnofsky Performance Index Score <70), advanced CKD (estimated glomerular filtration rate<20?mL/min/1.73?m2), prefer to speak English during clinical encounters and self-report as black or white race. Enrolled patients will be randomised 1:1, with stratification by race, to receive enhanced usual care or usual care and in-person education about conservative kidney management and ACP (COPE). The primary outcome is change in knowledge of CKM and ACP. We will also explore intervention feasibility and acceptability, change in communication of preferences and differences in the intervention's effects on knowledge and communication of preferences by race. We will assess outcomes at baseline, immediately post-education and at 2 and 12 weeks.Ethics and disseminationThis protocol has been approved by the Institutional Review Board at the University of Pennsylvania. We will obtain written informed consent from all participants. The results from this work will be presented at academic conferences and disseminated through peer-reviewed journals.Trial registration numberThis trial is registered at ClinicalTrials.gov under NCT03229811.

Dataset Information

Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial.

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Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial.

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