Establishing treatment fidelity in a web-based behavioral intervention study.
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ABSTRACT:
SUBMITTER: Eaton LH
PROVIDER: S-EPMC3235349 | biostudies-literature | 2011 Nov-Dec
REPOSITORIES: biostudies-literature
Publications
Establishing treatment fidelity in a web-based behavioral intervention study.
Eaton Linda H LH Doorenbos Ardith Z AZ Schmitz Krisann L KL Carpenter Kelly M KM McGregor Bonnie A BA
Nursing research 20111101 6
<h4>Background</h4>: Treatment fidelity pertains to the methodological strategies used to monitor and enhance the reliability and validity of behavioral interventions. Approaches to establishing treatment fidelity in Web-based interventions differ from those used in interventions that are delivered in person.<h4>Objective</h4>: The aim of this study was to describe a methodology for ensuring treatment fidelity in a Web-based cognitive behavioral stress management intervention.<h4>Methods</h4>: T ...[more]
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Project description:Attaining and demonstrating treatment fidelity is critical in the development and testing of evidence-based interventions. Treatment fidelity refers to the extent to which an intervention was implemented in clinical testing as it was conceptualized and is clearly differentiable from control or standard-of-care interventions. In clinical research, treatment fidelity is typically attained through intensive training and supervision techniques and demonstrated by measuring therapist adherence and competence to the protocol using external raters. However, in occupational and physical therapy outcomes research, treatment fidelity methods have not been used, which, in our view, is a serious gap that impedes novel treatment development and testing in these rehabilitation fields. In this article, we describe the development of methods to train and supervise therapists to attain adequate treatment fidelity in a treatment development project involving a novel occupational and physical therapy-based intervention. We also present a data-driven model for demonstrating therapist adherence and competence in the new treatment and its differentiation from standard of care. In doing so, we provide an approach that rehabilitation researchers can use to address treatment fidelity in occupational and physical therapy-based interventions. We recommend that all treatment researchers in rehabilitation disciplines use these or similar methods as a vital step in the development and testing of evidence-based rehabilitation interventions.
| S-EPMC3967862 | biostudies-literature
Project description:BACKGROUND:Technology-based lifestyle behavioral interventions (i.e., telehealth, mHealth, eHealth, and/or digital health) are becoming an alternative standard of care and possess several advantages over traditional clinical settings such as convenience, cost, and the ability to tailor plans and feedback to a participant's individual needs. These technology-based interventions also present unique challenges to intervention fidelity due to extra elements involved in executing the intervention. Intervention fidelity monitoring is essential to ensure internal and external validity, yet the development and utilization of fidelity protocols is under-reported in the literature. The purpose of this paper is to describe the intervention fidelity protocol for the 24-START study, a behavior change intervention delivered through telephone and internet. This paper also discusses the results of a pilot audit conducted to determine the feasibility of monitoring adherence to the fidelity protocol. METHODS:The 24-START fidelity protocol was developed in accordance with the five fidelity areas outlined by the NIH Behavior Change Consortium (NIH BCC) including: design of study, provider training, delivery of treatment, receipt of treatment, and enactment of treatment. The fidelity strategies provided by the NIH BCC in each area were tailored to fit the specific design of the 24-START study. Twenty-six total fidelity strategies were developed in accordance with the five areas and a corresponding fidelity monitoring plan was created. Because these strategies are only beneficial if implemented, the fidelity monitoring plan was developed to ensure the fidelity strategies are consistently implemented over the course of the intervention. RESULTS:A pilot audit of nine participant files was conducted to test the feasibility of the fidelity protocol developed. Out of the nine participant files reviewed, 89% of scheduled phone calls between a telehealth coach and participant were successfully completed. Of the completed calls, telehealth coaches delivered the intervention as intended 85.3% of the time, and 74% of planned secondary contacts made through the internet were delivered successfully. Additionally, between treatment group dosing was found to be equal. Several weak areas in the fidelity protocol were identified for improvement. The results were satisfactory and the audit was deemed feasible for ongoing use. CONCLUSIONS:The NIH BCC provides a valuable framework for telehealth interventions to develop fidelity protocols ultimately contributing to improved internal and external validity, better translation of results, increased transparency, and increased opportunities for replication within the field. The 24-START pilot audit found the fidelity protocol efficacious and feasible while also identifying areas of weakness in need of revision. The refined protocol will continue to be utilized throughout the data collection phase. Future telehealth interventions should develop and disclose fidelity protocols to improve the overall quality and standard of telehealth interventions.
| S-EPMC5583039 | biostudies-literature
Project description:BackgroundWeb-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).ObjectiveThe aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.MethodsWe assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.ResultsWhile groups did not differ regarding the change in depression from t0 to t1 (ηp2=.007, P=.746) or t0 to t2 (ηp2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (ηp2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (ηp2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.ConclusionsAlthough we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.Trial registrationDKRS (#DRKS00011562).
| S-EPMC7146239 | biostudies-literature
Project description:BackgroundPhysical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression.ObjectiveThe objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes.MethodsParticipants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes.ResultsOf the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference -3.6, 95% CI -6.1 to -1.1).ConclusionsIt was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures.Trial registrationClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).
| S-EPMC6066639 | biostudies-literature
Project description:BackgroundTo control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors.ObjectiveThis study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved.MethodsThis was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors.ResultsCurrent behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31).ConclusionsSelf-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.
| S-EPMC7909304 | biostudies-literature
Project description:BackgroundPhysical inactivity is a major risk factor for nonalcoholic fatty liver disease (NAFLD). Exercise-based prevention interventions for improving cardiorespiratory fitness are a recommended complementary treatment for NAFLD. Achievement of minimally effective physical activity to improve cardiorespiratory fitness among patients typically involves high personal and financial expenses in face-to-face settings. We designed an eHealth approach for patients with NAFLD to improve the cardiorespiratory fitness and report the first results of the HELP (Hepatic Inflammation and Physical Performance in Patients With NASH [nonalcoholic steatohepatitis]) study.ObjectiveWe aimed to assess the effectiveness of an 8-week, tailored, Web-based exercise intervention for cardiorespiratory fitness improvement, expressed as peak oxygen uptake (peak volume of oxygen [VO2peak]), in patients with histologically confirmed NAFLD.MethodsIn a 24-month period, 44 patients were enrolled into an 8-week, prospective, single-arm study with 12 weeks of follow-up. After a medical examination and performance diagnostics, a sports therapist introduced the patients to a Web-based platform for individualized training support. Regular individual patient feedback was provided to systematically adapt the weekly exercise schedule, which allowed us to monitor and ensure patient adherence to strength and endurance training and optimize the step-wise progressive exercise load. Exercise progression was based on an a priori algorithm that considered the subjective rate for both perceived exhaustion and general physical discomfort. The VO2peak was assessed at baseline and at the end of the study by spiroergometry.ResultsA total of 43 patients completed the intervention with no adverse events. The VO2peak increased significantly by 2.4 mL/kg/min (8.8%; 95% confidence interval [CI]: 1.48-3.27; P<.001) accompanied by a reduction of 1.0 kg in a body weight (95% CI: 0.33-1.58; P=.004) and 1.3 kg in body fat mass (95% CI: 0.27-2.27; P=.01). In an exploratory analysis, step-wise logistic regression analysis revealed low body fat and VO2peak at baseline and the total minutes of endurance training during the intervention as main contributors to a positive change in VO2peak. Our predictive model indicated that the average patient with NAFLD needed 223 min for stabilization of VO2peak and 628 min for average improvement in VO2peak. However, in patients with a VO2peak approximately 20% higher than the average VO2peak, 628 min were only sufficient to stabilize the VO2peak and >40% reduction in the average fat mass would be required to achieve an average outcome.ConclusionsThis is the first study to show that patients with NAFLD can be effectively supported by a Web-based approach, which can increase the VO2peak to a similar extent as face-to-face interventions. Patients with low body fat and low VO2peak benefited the most from our intervention. In terms of future treatment strategies, NAFLD patients with high body fat may particularly benefit from body-fat reduction through a strict nutritional intervention, subsequently enabling a more effective exercise intervention.Trial registrationClinicalTrials.gov NCT02526732; https://clinicaltrials.gov/ct2/show/NCT02526732 (Archived by WebCite at http://www.webcitation.org/74pXhXXfq).International registered report identifier (irrid)RR2-10.2196/resprot.8607.
| S-EPMC6746083 | biostudies-literature
Project description:Evidence of the impact of water, sanitation, and hygiene (WASH) in schools (WinS) interventions on pupil absence and health is mixed. Few WinS evaluations rigorously report on output and outcome measures that allow for comparisons of effectiveness between interventions to be made, or for an understanding of why programs succeed. The Water, Sanitation, and Hygiene for Health and Education in Laotian Primary Schools (WASH HELPS) study was a randomized controlled trial designed to measure the impact of the United Nations Children's Fund (UNICEF) Laos WinS project on child health and education. We also measured the sustainability of intervention outputs and outcomes, and analyzed the effectiveness of group hygiene activities on behavior change and habit formation. Here, we present the design and intermediate results from this study. We found the WinS project improved the WASH environment in intervention schools; 87.8% of schools received the intervention per design. School-level adherence to outputs was lower; on average, schools met 61.4% of adherence-related criteria. The WinS project produced positive changes in pupils' school WASH behaviors, specifically increasing toilet use and daily group handwashing. Daily group hygiene activities are effective strategies to improve school WASH behaviors, but a complementary strategy needs to be concurrently promoted for effective and sustained individual handwashing practice at critical times.
| S-EPMC5923612 | biostudies-literature
Project description:A global pandemic due to COVID-19 emerged in November 2019 and hit France in early March 2020. It not only resulted in a loss of lives, but also in very strict confinement measures. The objective of this study was to understand what the determinants of the changes in participants' behavior and mental state were during the confinement. An online survey was launched on 23 April 2020 and closed on 7 May 2020. The final sample included 1454 participants from 24 to 65 years old. Descriptive and multivariate analyses were then performed. In total, 28.7% reported having a more balanced diet, against 17.1% with a less balanced diet, 22.7% of respondents reported an increased alcohol consumption, as opposed to only 12.2% declaring a decrease, and 11.2% of respondents increased their tobacco consumption, while 6.3% decreased it. In total, 50.6% of the participants reported being more depressed, stressed, or irritable since the beginning of the lockdown. Confinement had a negative effect on every behavior studied in this survey, except for nutrition. We also found that negative mental state changes were strongly associated with nutrition, sleep, physical activity and alcohol consumption changes.
| S-EPMC7696923 | biostudies-literature
Project description:BACKGROUND:The rate of physical activity is substantially lower in persons with multiple sclerosis (MS) than in the general population. This problem can be reversed through rigorous and reproducible delivery of behavioral interventions that target lifestyle physical activity in MS. These interventions are, in part, based on a series of phase II randomized controlled trials (RCTs) supporting the efficacy of an internet-delivered behavioral intervention, which is based on social cognitive theory (SCT) for increasing physical activity in MS. OBJECTIVE:This paper outlines the strategies and monitoring plan developed based on the National Institutes of Health Behavior Change Consortium (NIH BCC) treatment fidelity workgroup that will be implemented in a phase III RCT. METHODS:The Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) study is a phase III RCT that examines the effectiveness of an internet-delivered behavioral intervention based on SCT and is supported by video calls with a behavioral coach for increasing physical activity in MS. BIPAMS includes a 6-month treatment condition and 6-month follow-up. The BIPAMS fidelity protocol includes the five areas outlined by the NIH BCC. The study design draws on the SCT behavior-change strategy, ensures a consistent dose within groups, and plans for implementation setbacks. Provider training in theory and content will be consistent between groups with monitoring plans in place such as expert auditing of calls to ensure potential drift is addressed. Delivery of treatment will be monitored through the study website and training will focus on avoiding cross-contamination between conditions. Receipt of treatment will be monitored via coaching call notes and website monitoring. Lastly, enactment of treatment for behavioral and cognitive skills will be monitored through coaching call notes among other strategies. The specific strategies and monitoring plans will be consistent between conditions within the constraints of utilizing existing evidence-based interventions. RESULTS:Enrollment began in February 2018 and will end in September 2019. The study results will be reported in late 2020. CONCLUSIONS:Fidelity-reporting guidelines provided by the NIH BCC were published in 2004, but protocols are scarce. This is the first fidelity-monitoring plan involving an electronic health behavioral intervention for increasing physical activity in MS. This paper provides a model for other researchers utilizing the NIH BCC recommendations to optimize the rigor and reproducibility of behavioral interventions in MS. TRIAL REGISTRATION:ClinicalTrials.gov NCT03490240; https://www.clinicaltrials.gov/ct2/show/NCT03490240. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12319.
| S-EPMC6418483 | biostudies-literature
Project description:IntroductionAdoption of rigorous standards for reporting treatment fidelity is essential for advancing discovery, validation, and implementation of behavioral treatments. Whereas the NIH Behavior Change Consortium (BCC) developed an assessment tool to assess the quality of reporting and monitoring of treatment fidelity across health behavior change interventions, it has not yet been applied specifically to treatment fidelity in behavioral tobacco treatment trials.Aims and methodsWe conducted a scoping review of peer-reviewed, clinical trials of behavioral adult tobacco treatment interventions published in English between 2006 and 2018. Using the BCC treatment fidelity checklist, articles were coded for the presence or absence of various treatment fidelity strategies within each of 5 domains: Design, Training, Delivery, Receipt, and Enactment. Eligible articles (N = 755) were coded by two independent coders.ResultsThe proportion of reporting strategies varied within the fidelity domains, ranging from 5.2% to 96.3% in Design, 1.9% to 24.9% in Training, 2.6% to 32.3% in Delivery, 5.2% to 44.3% in Receipt, and 6.7% to 43.2% in Enactment. The mean proportion of adherence to treatment fidelity strategies within each domain was: Design (68%), Training (14%), Delivery (15%), Receipt (16%), and Enactment (25%). Only 11 studies achieved ≥80% reporting across >1 fidelity domain. There was no evidence for improvement in fidelity reporting across the 13-year time frame from the initial BCC publication to the present.ConclusionsThese findings illustrate the lack of consistency in fidelity reporting in tobacco treatment trials and underscore the challenges faced in evaluating rigor and reproducibility, as well as interpretation and dissemination of findings. Recommendations are made for improving fidelity reporting in tobacco treatment trials.ImplicationsThe SRNT Treatment Research Network sponsored a scoping review to summarize the current state of reporting treatment fidelity and make recommendations for best practices in reporting fidelity in tobacco treatment trials. The review identified a lack of consistency in fidelity reporting, illustrating the challenges faced in evaluating rigor, and reproducibility, as well as interpretation and dissemination of findings.
| S-EPMC9013002 | biostudies-literature