Developing Social Enhancements for a Web-Based, Positive Emotion Intervention for Alzheimer Disease Caregivers: Qualitative Focus Group and Interview Study.

BACKGROUND: Alzheimer disease is a degenerative neurological condition that requires long-term care. The cost of these responsibilities is often borne by informal caregivers, who experience an elevated risk of negative physical and psychological outcomes. Previously, we designed a positive emotion regulation intervention that was shown to improve well-being among dementia caregivers when delivered through one-on-one videoconferencing lessons with a trained facilitator. However, the format required significant resources in terms of logistics and facilitator time. To broaden the reach of the intervention, we aimed to develop the Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF) program, an iteration of the intervention in a self-guided, web-based format with enhanced opportunities for social connection. OBJECTIVE: The aim of this study was to gather feedback to inform the design of social features for the SAGE LEAF intervention. In the absence of a facilitator, our goal with the self-guided SAGE LEAF intervention was to integrate various social features (eg, discussion board, automated support, and profiles) to maximize engagement among participants. METHODS: Qualitative data were collected from 26 individuals through (1) interviews with participants who completed a previous version of the intervention via videoconferencing with a facilitator, (2) focus groups with dementia caregivers who had not previously experienced the intervention, and (3) focus groups with Alzheimer disease clinical care providers. We conducted a qualitative thematic analysis to identify which social features would be the most helpful and how they could be implemented in a way that would be best received by caregivers. RESULTS: Interview and focus group feedback indicated that participants generally liked the potential features suggested, including the discussion boards, multimedia content, and informational support. They had valuable suggestions for optimal implementation. For example, participants liked the idea of a buddy system where they would be matched up with another caregiver for the duration of the study. However, they expressed concern about differing expectations among caregivers and the possibility of matched caregivers not getting along. Participants also expressed interest in giving caregivers access to a podcast on the skills, which would allow them to review additional content when they wished. CONCLUSIONS: Taken together, the discussions with caregivers and providers offered unique insights into the types of social features that may be integrated into the SAGE LEAF intervention, as well as implementation suggestions to improve the acceptability of the features among caregivers. These insights will allow us to design social features for the intervention that are optimally engaging and helpful for caregivers.

Randomized controlled trial of a positive emotion regulation intervention to reduce stress in family caregivers of individuals with Alzheimer's disease: protocol and design for the LEAF 2.0 study.

BACKGROUND: Caring for a loved one with Alzheimer's disease can be stressful, resulting in poorer emotional and physical health among family caregivers. Although supportive resources for caregivers are available, distance, caregiver health, and the daily demands of caregiving are barriers to access. Based on research demonstrating the importance of positive emotions in coping with stress, our previous trial showed that dementia caregivers who participated in facilitated, web-based delivery of a positive emotion regulation intervention called LEAF (Life Enhancing Activities for Family caregivers) experienced increased positive emotion and decreased depression and anxiety. Building on this evidence, the LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer's disease. METHODS: This paper presents the design and methods for LEAF 2.0, a 3-arm web-based randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's disease (AD) are randomized to (1) the LEAF intervention facilitated remotely via the web (N = 200), (2) the LEAF intervention self-guided online (N = 200), or (3) an emotion reporting control (N = 100), which then crosses over to the intervention after approximately 6 months, half to the facilitated arm and half to the self-guided arm. We aim to (1) compare the effect of the facilitated and self-guided LEAF positive emotion interventions to an emotion reporting control condition on AD caregiver well-being (positive emotion, depression, anxiety, and perceived stress) and secondary outcomes (caregiving burden, caregiving self-efficacy, positive aspects of caregiving, quality of care, and AD patient quality of life); (2) assess whether effects are mediated by improvements in positive emotion or other aspects of caregiver well-being; and (3) test whether caregiver age or gender or the care recipient's dementia severity moderates the effects of the intervention. DISCUSSION: If demonstrated to be effective, LEAF can be widely disseminated and ultimately have a significant impact on the stress experienced by AD caregivers and the well-being of people living with Alzheimer's disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT03610698.

Acceptability and Feasibility of a Socially Enhanced, Self-Guided, Positive Emotion Regulation Intervention for Caregivers of Individuals With Dementia: Pilot Intervention Study.

BACKGROUND: The responsibilities of being a primary caregiver for a loved one with dementia can produce significant stress for the caregiver, leading to deleterious outcomes for the caregiver's physical and psychological health. Hence, researchers are developing eHealth interventions to provide support for caregivers. Members of our research team previously developed and tested a positive emotion regulation intervention that we delivered through videoconferencing, in which caregiver participants would meet one-on-one with a trained facilitator. Although proven effective, such delivery methods have limited scalability because they require significant resources in terms of cost and direct contact hours. OBJECTIVE: This study aimed to conduct a pilot test of a socially enhanced, self-guided version of the positive emotion regulation intervention, Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF). Studies have shown that social presence or the perception of others in a virtual space is associated with enhanced learning and user satisfaction. Hence, the intervention leverages various social features (eg, discussion boards, podcasts, videos, user profiles, and social notifications) to foster a sense of social presence among participants and study team members. METHODS: Usability, usefulness, feasibility, and acceptability data were collected from a pilot test in which participants (N=15) were given full access to the SAGE LEAF intervention over 6 weeks and completed preintervention and postintervention assessments (10/15, 67%). Preliminary outcome measures were also collected, with an understanding that no conclusions about efficacy could be made, because our pilot study did not have a control group and was not sufficiently powered. RESULTS: The results suggest that SAGE LEAF is feasible, with participants viewing an average of 72% (SD 42%) of the total available intervention web pages. In addition, acceptability was found to be good, as demonstrated by participants' willingness to recommend the SAGE LEAF program to a friend or other caregiver. Applying Pearson correlational analyses, we found moderate, positive correlation between social presence scores and participants' willingness to recommend the program to others (r9=0.672; P=.03). We also found positive correlation between social presence scores and participants' perceptions about the overall usefulness of the intervention (r9=0.773; P=.009). This suggests that participants' sense of social presence may be important for the feasibility and acceptability of the program. CONCLUSIONS: In this pilot study, the SAGE LEAF intervention demonstrates potential for broad dissemination for dementia caregivers. We aim to incorporate participant feedback about how the social features may be improved in future iterations to enhance usability and to further bolster a sense of social connection among participants and study staff members. Next steps include partnering with dementia clinics and other caregiver-serving organizations across the United States to conduct a randomized controlled trial to evaluate the effectiveness of the intervention.

Exploring Retention, Usage, and Efficacy of Web-Based Delivery of Positive Emotion Regulation Skills During the COVID-19 Pandemic.

COVID-19 prompted distress and increased reliance on digital mental health interventions, which previously demonstrated low rates of retention and adherence. This single-arm trial evaluated whether self-guided, web-based, positive affect regulation skills (PARK) were engaging and associated with changes in well-being during the pandemic. Over 6 weeks, PARK delivers brief lessons and practices in skills designed to increase positive emotions: noticing positive events, savoring, gratitude, mindfulness, positive reappraisal, personal strengths, and self-compassion. Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive tests of anxiety, depression, social isolation, positive affect, and meaning and purpose were administered at baseline, post-intervention, and 6 months after baseline. Retention and usage of PARK were measured by the web-based assessment and intervention platforms. The sample (n = 616) was predominantly female, non-Hispanic, white, and well-educated. Of those who completed baseline, only 42% completed a follow-up assessment; 30% never logged into PARK. Among those who did, 86% used at least one skill, but only 14% completed PARK. Across retention and usage metrics, older age predicted more engagement. In multivariable models, people of color and people with greater baseline anxiety were more likely to complete PARK. All well-being indicators improved over time, with greater improvements in anxiety and social isolation among participants who accessed at least one PARK skill compared to those who did not. Retention and usage rates mirrored pre-pandemic trends, but within this select sample, predictors of engagement differed from prior research. Findings underscore the need for additional efforts to ensure equitable access to digital mental health interventions and research. Trials registration: NCT04367922.

The Development of iManage-PC, an Online Symptom Monitoring and Self-management Tool for Men With Clinically Localized Prostate Cancer.

BACKGROUND: Prostate cancer (PC) often impacts 4 major aspects of health-related quality of life (HRQL): urinary, sexual, and bowel dysfunction, and anxiety. Online tools may be helpful in supporting the development of self-management skills that can improve HRQL. OBJECTIVE: The aim of this study was to develop and pilot-test an online symptom monitoring and self-management program, iManage-PC. METHODS: A literature search, input from experts, and feedback from patients were used to develop iManage-PC. A 4-week, single-arm pilot study was conducted with 96 men with prostate cancer. We evaluated system usability, acceptance, and satisfaction and examined preliminary effects on patient-reported outcomes. RESULTS: Rates of retention (94.8%) and adherence to symptom monitoring (95.0%-97.0%) were high. Most participants rated the tool as satisfactory and acceptable (81.2%-94.3%). Related-samples Wilcoxon signed rank tests revealed that participants reported increased self-efficacy related to their ability to manage their adverse effects (T = 1772.0, P < .001, r = 0.39), physical discomfort (T = 1259.0, P < .001, r = 0.40), and stress and worry (T = 1108.5, P = .001, r = 0.34). Global mental and physical health also improved (T = 1322.0, P = .032, r = 0.23, and T = 1409.0, P = .001, r = 0.35, respectively). CONCLUSIONS: Future research with such tools should examine the potential role of cut-score-derived management interventions to improve engagement, symptom management self-efficacy, and HRQL. IMPLICATIONS FOR PRACTICE: Our findings are consistent with a growing body of literature that supports the feasibility and acceptability of remotely delivered interventions.

Lessons learned from a blended telephone/e-health platform for caregivers in promoting physical activity and nutrition in children with a mobility disability.

BACKGROUND: Children with physical disabilities report higher rates of sedentary lifestyle and unhealthy dietary patterns than non-disabled peers. These behaviors can increase comorbidities, caregiver burden, and healthcare costs. Innovative interventions are needed to assist caregivers of children with physical disabilities improve health behaviors. OBJECTIVE: /Hypothesis: The purpose of this pilot study was to test the usability and preliminary efficacy of an e-health and telecoaching intervention compared to telecoaching alone. METHODS: Parent/child dyads (n = 65) were randomized into either the e-health and telephone group (e-HT) or the telephone only group (TO). All participants received regular calls from a telecoach, and the e-HT group received access to a website with personalized weekly goals for diet and physical activity, and access to resources to meet these goals. At the conclusion of the intervention, participants in the e-HT group were asked to complete a semi-structured interview to discuss the usability of the e-health platform. RESULTS: Fifty of the 65 randomized dyads (77%) completed all baseline measures and had at least one intervention call. Forty families (80% of those that started the intervention) completed the study (50% spina bifida, 24% mobility limitation, diagnosis not reported). Age of the children ranged from 6 to 17 years old. Both groups had high adherence to scheduled phone calls (e-HT (n = 17): 81%, TO (n = 23): 86%); however no significant differences in dietary intake or physical activity were seen within or between groups. Primary themes to emerge from qualitative interviewers were: the platform should target children rather than parents, parents valued the calls more than the website, and schools need to be involved in interventions. CONCLUSIONS: E-health interventions are a promising way to promote healthy behaviors in children with physical disability, but technology must be balanced with ease of use for parents while also engaging the child.

The MARIGOLD study: Feasibility and enhancement of an online intervention to improve emotion regulation in people with elevated depressive symptoms.

BACKGROUND: This manuscript describes the first two phases of pilot testing MARIGOLD, an online self-guided positive emotion skills intervention for adults with elevated depressive symptoms, along with enhancements to overcome retention and adherence problems reported in previous research. METHODS: Adults with elevated depressive symptoms were recruited online and assessed at baseline, post-intervention, 1- and 3-month follow-up. Phase 1 participants (n = 58) were randomized to MARIGOLD, daily emotion reporting, or waitlist. Phase 2 participants (n = 79) were randomized to MARIGOLD plus one enhancement: online discussion board (ODB), virtual badges (VB), or facilitator contact (FC). Post-intervention interviews assessed acceptability. Intention-to-treat analyses examined retention, adherence, and preliminary efficacy. RESULTS: In both phases, retention and adherence did not differ between groups. MARIGOLD skills were highly acceptable, but qualitative results indicate web-based features (e.g., log-in, ODB, VB) require refinement prior to larger testing. Neither phase demonstrated between-group differences in preliminary efficacy. In Phase 1 within-group analyses, MARIGOLD and emotion reporting control demonstrated a similar pattern of findings (stable depressive symptoms, increased positive emotion, decreased negative emotion and stress), whereas the waitlist group significantly increased in depressive mood. Most Phase 2 within-group analyses demonstrated the expected pattern of results (i.e., decreases in PHQ-8 and negative emotion, increases in positive emotion). However, CES-D scores were stable in FC; perceived stress was stable in FC and ODB. LIMITATIONS: This pilot study is not powered to evaluate efficacy. CONCLUSION: Positive emotion skills, plus enhancements for web-based, self-guided delivery, warrant additional study in people with elevated depressive symptoms.

Sexual risk behavior and viremia among men who have sex with men in the HIV Outpatient Study, United States, 2007-2010.

BACKGROUND: Recent US data on unsafe sexual behaviors among viremic HIV-infected men who have sex with men (MSM) are limited. METHOD: Using data abstracted from medical records of the participants in the HIV Outpatient Study (HOPS) and a supplemental behavioral survey, we assessed the frequency of high-risk sexual practices among HIV-infected MSM in care and examined the factors associated with risky sexual practices. We also compared the frequency of unprotected anal sex (UAS) with HIV-negative or unknown serostatus partners among viremic (HIV viral load ≥400 copies per milliliter) vs virologically suppressed (HIV viral load <400 copies per milliliter) MSM. RESULTS: Among 902 HIV-infected MSM surveyed, 704 (78%) reported having sex in the past 6 months, of whom 54% reported UAS (37% insertive, 42% receptive) and 40% UAS with a male partner who was HIV-negative or of unknown serostatus (24% insertive, 31% receptive). In multivariable regression with an outcome of engaging in any UAS with a male partner who was HIV-negative or of unknown serostatus, MSM aged <50 years, who reported injection drug use risk, had ≥2 sex partners, and who disclosed their HIV status to some but not to all of their sex partners were more likely to report this practice. Among MSM who reported any UAS, 15% were viremic; frequency of the UAS did not differ between viremic and virologically suppressed MSM. CONCLUSIONS: The high frequency of UAS with HIV-negative or unknown-status partners among HIV-infected MSM in care suggests the need for targeted prevention strategies for this population.

A technical solution to improving palliative and hospice care.

PURPOSE: This project sought to help palliative and hospice care practices improve patient care quality and operational efficiency by improving patient symptom status reporting and symptom management, reducing associated provider documentation workload, and enhancing patient-provider and provider-provider communication. We developed a user-friendly, electronic medical record-compatible, software prototype that allows typical clinical data and patient-reported outcomes (PRO) to be entered and stored. This data is immediately available during the clinical encounter with graphically depicted summaries for patient history and PRO assessments, a trending feature that links symptom behavior to interventions and the Edmonton Labeled Visual Information System. METHODS: A user-centered design approach allowed for iterative cycles of needs/usability feedback from providers and patients/caregivers to be incorporated into the development of our prototype's technical structure and features. To determine the needs and initial usability of the project's prototype, we interviewed eight providers and 18 patients/caregivers. Another usability test, consisting of patient/caregiver (n = 18) and provider (n = 9) interviews, assessed the functioning prototype's design, usability, and usefulness. RESULTS: Patients/caregivers (n = 18) reported that the prototype was usable (100%), it would facilitate patient-provider communication, shared decision making, and self-management (100%), and they would be willing to try the system and recommend it to their providers (100%). The providers (n = 9) felt that the prototype encouraged better use of patient assessments in decision making and patient care (100%) and improved identification of cause/temporal relationship between care events and outcomes (100%), monitoring of patient status (100%), communication in a multi-disciplinary team (100%), and operational efficiency and patient care quality (88.9%). CONCLUSIONS: Quality of patient care and operational efficiency can be improved with an effective assessment, evaluation, and communication tool. This project developed an electronic version of such a tool. Future efforts will hone its usability and integration across multiple hospice/palliative care settings.