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BACKGROUND: Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. PURPOSE: Our purpose is to describe the protocol to evaluate Pocket PATH (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial (RCT) to evaluate health IT intended for patient use. METHODS: An overview of the study protocol is presented. Unique considerations for health IT intervention trials and strategies are described to maintain equipoise, to monitor data safety and intervention fidelity, and to keep pace with changing technology during such trials. LESSONS LEARNED: The sovereignty granted to technology, the rapid pace of changes in technology, ubiquitous use in health care, and obligation to maintain the safety of research participants challenge researchers to address these issues in ways that maintain the integrity of intervention trials designed to evaluate the impact of health IT interventions intended for patient use. CONCLUSIONS: Our experience evaluating the efficacy of Pocket PATH may provide practical guidance to investigators about how to comply with established procedures for conducting RCTs and include strategies to address the unique issues associated with the evaluation of health IT for patient use.

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Self-care behaviors are crucial for following the complex regimen after lung transplantation, yet little is known about recipients' levels of self-care agency (the capability and willingness to engage in self-care behaviors) and its correlates. We examined levels of self-care agency and recipient characteristics (socio-demographics, psychological distress, quality of relationship with primary lay caregiver, and health locus of control) in 111 recipients. Based on Perceived Self-Care Agency scores, recipients were assigned to either the low- or high-self-care agency comparison group. Characteristics were compared between groups to identify characteristics likely to be associated with lower-self-care agency. Mean (SD) score for self-care agency (scale range, 53-265) was 223.02 (22.46). Recipients with lowest-self-care agency scores reported significantly poorer quality of caregiver relationships (p < 0.001) and greater psychological distress (p < 0.001). After controlling for psychological distress, the quality of the recipient-caregiver relationship remained significantly associated with self-care agency. Every one-point decrease in the quality of caregiver relationship increased the risk of low-self-care agency by 12%. Recipients with poorer caregiver relationships and greater psychological distress may need additional support to perform the self-care behaviors expected after lung transplantation.

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CONTEXT: Lung transplant recipients are prescribed a complex medical regimen that is thought to be burdensome and to interfere with daily activities of recipients and family caregivers. Yet empirical studies describing the activities that lung transplant recipients and their family caregivers perform on a typical day and the emotions associated with performing these activities are lacking. OBJECTIVE: To identify the daily activities and burdens after lung transplant. DESIGN: The Day Reconstruction Method and content analysis were used to reconstruct a typical day for lung transplant recipients and their family caregivers. SETTING: The adult cardiothoracic transplant program of The University of Pittsburgh Medical Center. PARTICIPANTS: Twenty-one dyads of lung transplant recipients and their family caregivers. MAIN OUTCOME MEASURES: Variables of interest included lung transplant recipients' and family caregivers' daily activities and associated emotions, sociodemographics, clinical characteristics, and patient-reported outcomes of quality of life, symptoms of depression and anxiety, and functional performance. RESULTS: Participants reported 286 daily activities and 138 associated positive and negative emotions. No activities or emotions were uniquely reported by lung transplant recipients or caregivers, providing evidence of the shared responsibility for caregiving and health maintenance. Most activities reported by caregivers and lung transplant recipients were health-related. Compared with lung transplant recipients, caregivers reported positive emotions more often, yet reported lower overall daily mood. This finding is consistent with results of previous studies indicating that specific caregiving tasks were typically rewarding for caregivers, but overall, care giving takes its toll. CONCLUSION: Findings enhance our understanding of the burdens lung transplant recipients and caregivers face and point to the need for further support for dyads after lung transplant.

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BACKGROUND: Despite the proliferation of health technologies, descriptions of the unique considerations and practical guidance for evaluating the intervention fidelity of technology-based behavioral interventions are lacking. OBJECTIVES: The aims of this study were to (a) discuss how technology-based behavioral interventions challenge conventions about how intervention fidelity is conceptualized and evaluated, (b) propose an intervention fidelity framework that may be more appropriate for technology-based behavioral interventions, and (c) present a plan for operationalizing each concept in the framework using the intervention fidelity monitoring plan for Pocket PATH (Personal Assistant for Tracking Health), a mobile health technology designed to promote self-care behaviors after lung transplantation, as an exemplar. METHOD: The literature related to intervention fidelity and technology acceptance was used to identify the issues that are unique to the fidelity of technology-based behavioral interventions and thus important to include in a proposed intervention fidelity framework. An intervention fidelity monitoring plan for technology-based behavioral interventions was developed as an example. RESULTS: The intervention fidelity monitoring plan was deemed feasible and practical to implement and showed utility in operationalizing the concepts such as assessing interventionists' delivery and participants' acceptance of the technology-based behavioral intervention. DISCUSSION: The framework has the potential to guide the development of implementation fidelity monitoring tools for other technology-based behavioral interventions. Further application and testing of this framework will allow for a better understanding of the role that technology acceptance plays in the adoption and enactment of the behaviors that technology-based behavioral interventions are intended to promote.

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Investigators conducting research involving human subjects are obligated to safeguard the wellbeing of the study participants. Other than requiring investigators to establish procedures for ongoing monitoring and reporting of adverse events, federal regulations do not dictate how human subject safety should be ensured. A variety of data safety monitoring (DSM) procedures may be acceptable depending on the nature, size, and complexity of the study. However, practical guidance for establishing and implementing appropriate DSM plans for such studies are lacking. In this article, we provide a review of the DSM considerations associated with monitoring health remotely and describe the Pocket Personal Assistant for Tracking Health project as an exemplar for how to develop effective DSM plans for research that captures clinical data using remote health-monitoring devices. Protecting the safety and welfare of participants is one of the most important mandates for research involving human subjects. Investigators have an ethical and scientific responsibility to monitor the safety of research participants. Investigators typically fulfill this responsibility by monitoring and reporting adverse events.

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The art and practice of nursing in today's health care arena is becoming increasingly complex. One of the newest challenges in the field of behavioral health is the integration of quality health care with information technology. The authors of this paper examine four emerging aspects of information technology: the electronic medical record, automated medication distribution systems, computerized charting, and hand-held computers. The benefits, costs, uses of these technologies, and the potential problems they can provide in the field of behavioral health are discussed. Implications for nursing practice also are explored.

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