UNASSIGNED: Health coaching may supplement the multidisciplinary ALS clinic model to facilitate patient-centered health behavior change. The aim of this study was to determine the effects of nurse health coaching (NHC) on the quality of life and self-efficacy of individuals living with ALS.
UNASSIGNED: Twenty-nine participants were randomized at 1:1 to the standard of care and coaching arms. All participants attended multidisciplinary ALS clinic visits quarterly, at which times they completed assessments of quality of life and self-efficacy. Those in the coaching arm participated in monthly coaching with a nurse coach over 12 months. The coaching sessions utilized motivational interviewing to identify personal goals along with barriers and solutions to achieve them. Linear mixed-effect models were used to quantify the effect of coaching on quality of life and self-efficacy outcomes. Thematic analysis was performed to summarize the participants\' experiences with coaching.
UNASSIGNED: Adherence to the coaching intervention was good. No effects of coaching were observed on the primary outcomes of quality of life and self-efficacy, although debriefed participants reported that they would recommend it to others. Patients and caregivers reflected on the impacts of coaching that extended beyond the pre-defined study outcomes and measures put in place to gauge effectiveness.
UNASSIGNED: The elicited qualitative themes illustrating patient experience of coaching demonstrate the utility of nurse coaching as an important adjunct support to complement the multidisciplinary ALS clinic model.

BACKGROUND: Delivering prescription digital therapeutics (ie, evidence-based interventions designed to treat, manage, or prevent disorders via websites or smartphone apps) in primary care could increase patient access to substance use disorder (SUD) treatments. However, the optimal approach to implementing prescription digital therapeutics in primary care remains unknown.
OBJECTIVE: This pilot study is a precursor to a larger trial designed to test whether implementation strategies (practice facilitation [PF] and health coaching [HC]) improve the delivery of prescription digital therapeutics for SUDs in primary care. This mixed methods study describes outcomes among patients in the 2 pilot clinics and presents qualitative findings on implementation.
METHODS: From February 10 to August 6, 2021, a total of 3 mental health specialists embedded in 2 primary care practices of the same integrated health system were tasked with offering app-based prescription digital therapeutics to patients with SUD. In the first half of the pilot, implementation activities included training and supportive tools. PF (at 1 clinic) and HC (at 2 clinics) were added in the second half. All study analyses relied on secondary data, including electronic health records and digital therapeutic vendor data. Primary outcomes were the proportion of patients reached by the prescription digital therapeutics and fidelity related to ideal use. We used qualitative methods to assess the adherence to planned activities and the barriers and facilitators to implementing prescription digital therapeutics.
RESULTS: Of all 18 patients prescribed the apps, 10 (56%) downloaded the app and activated their prescription, and 8 (44%) completed at least 1 module of content. Patients who activated the app completed 1 module per week on average. Ideal use (fidelity) was defined as completing 4 modules per week and having a monthly SUD-related visit; 1 (6%) patient met these criteria for 10 weeks (of the 12-week prescription period). A total of 5 (28%) patients had prescriptions while HC was available, 2 (11%) were successfully contacted, and both declined coaching. Clinicians reported competing clinical priorities, technical challenges, and logistically complex workflows in part because the apps required a prescription. Some pilot activities were impacted by staff turnover that coincided with the COVID-19 pandemic. The facilitators to implementation were high engagement and the perception that the apps could meet patient needs.
CONCLUSIONS: The pilot study encountered the barriers to implementing prescription digital therapeutics in a real-world primary care setting, especially staffing shortages, turnover, and competing priorities for clinic teams. The larger randomized trial will clarify the extent to which PF and HC improve the implementation of digital therapeutics.
BACKGROUND: ClinicalTrials.gov NCT04907045; https://clinicaltrials.gov/study/NCT04907045.

UNASSIGNED: To collect health and wellness coaching (HWC) literature related to treatment of obesity and Type 2 Diabetes (T2D) for systematic assessment using a novel rubric.
UNASSIGNED: Pubmed, CINAHL, and PsychInfo.
UNASSIGNED: Given 282 articles retrieved, only randomized and controlled trials meeting a HWC criteria-based definition were included; studies with intervention <4 months or <4 sessions were excluded.
UNASSIGNED: Rubric assessment required details of two theoretical frameworks (i.e., study design and HWC intervention design) be extracted from each included paper.
UNASSIGNED: Data were derived from a 28-item rubric querying items such as sampling characteristics, statistical methods, coach characteristics, HWC strategy, and intervention fidelity.
UNASSIGNED: 29 articles were reviewed. Inter-rater rubric scoring yielded high intraclass correlation (r = .85). Rubric assessment of HWC literature resulted in moderate scores (56.7%), with study design scoring higher than intervention design; within intervention design, T2D studies scored higher than obesity.
UNASSIGNED: A novel research design rubric is presented and successfully applied to assess HWC research related to treatment of obesity and T2D. Most studies reported beneficial clinical findings; however, rubric results revealed moderate scores for study and intervention design. Implications for future HWC research are discussed.

UNASSIGNED: Opt2Move is a theory-guided moderate and vigorous physical activity (MVPA) promotion trial that uses multiphase optimization strategy (MOST) methodology to evaluate the individual and combined effects of four intervention components in a full factorial experiment among young adult cancer survivors (YACS; N = 304). All participants will receive the core mHealth MVPA intervention, which includes a Fitbit and standard self-monitoring Opt2Move smartphone application. YACS will be randomized to one of 16 conditions to receive between zero and four additional components each with two levels (yes v. no): E-Coach, buddy, general mindfulness, and MVPA-specific mindfulness.
UNASSIGNED: The primary aim is to determine the individual and combined effects of the components on MVPA post-intervention (12-weeks) and at 24-week follow-up. The secondary aim is to examine how changes in MVPA are associated with patient-reported outcomes, light-intensity activity, sedentary time, and sleep duration and quality. Potential mediators and moderators of component effects will also be examined.
UNASSIGNED: Results will support the selection of a package of intervention components optimized to maximize MVPA to be tested in a randomized controlled trial.
UNASSIGNED: Opt2Move represents the first systematic effort to use MOST to design an optimized, scalable mHealth MVPA intervention for YACS and will lead to an improved understanding of how to effectively change YACS\' MVPA and ultimately, improve health and disease outcomes.

BACKGROUND: Digital health interventions show promise for weight management. However, few text-based behavior change interventions have been designed to support patients receiving intragastric balloons, and none have simultaneously evaluated weight loss, psychological well-being, and behavior change despite the crucial interplay of these factors in weight management.
OBJECTIVE: This study aims to assess whether a health coach-led, asynchronous, text-based digital behavior change coaching intervention (DBCCI) delivered to participants receiving an intragastric balloon and its aftercare program was feasible and acceptable to participants and supported improved outcomes, including weight loss, psychological well-being, and lifestyle behavior change conducive to weight loss maintenance.
METHODS: This 12-month, single-arm prospective study enrolled adults aged 21 to 65 years with BMI ≥27 kg/m2 receiving a procedureless intragastric balloon (PIGB) at 5 bariatric clinics in the United Kingdom and the Netherlands. Participants received the DBCCI and the clinic-led PIGB aftercare program (remotely delivered) for 6 months after PIGB placement and then no intervention for an additional 6 months. The DBCCI was an evidence-based, personalized intervention wherein health coaches supported participants via exchanged asynchronous in-app text-based messages. Over the 12-month study, we assessed percentage of total body weight loss and psychological well-being via self-administered validated questionnaires (Warwick-Edinburgh Mental Wellbeing Scale, Generalized Anxiety Disorder Scale, Impact of Weight on Quality of Life-Lite-Clinical Trials Version, Loss of Control Over Eating Scale-Brief, Weight Efficacy Lifestyle Questionnaire-Short Form, and Barriers to Being Active Quiz). Participant engagement with and acceptability of the intervention were assessed via self-reported surveys.
RESULTS: Overall, 107 participants (n=96, 89.7% female; mean baseline BMI 35.4, SD 5.4 kg/m2) were included in the analysis. Mean total body weight loss was 13.5% (SEM 2.3%) at the end of the DBCCI and 11.22% (SEM 2.3%) at the 12-month follow-up (P<.001). Improvements were observed for all psychological well-being measures throughout the 12 months except for the Generalized Anxiety Disorder Scale (improvement at month 1) and Barriers to Being Active Quiz (improvements at months 3 and 6). Surveys showed high levels of engagement with and acceptability of the DBCCI.
CONCLUSIONS: This study provides evidence that the health coach-led, asynchronous, text-based DBCCI was engaging and acceptable to participants with overweight and obesity. The DBCCI, delivered alongside the PIGB and its aftercare program, supported improved weight loss outcomes and psychological well-being versus baseline and was associated with lifestyle behavior changes known to help achieve and maintain long-term weight loss and improved health outcomes. Follow-up findings suggest a potential need for longer-term, more intense coaching to focus on weight loss maintenance and support ongoing self-coaching. This could be achieved by leveraging generative artificial intelligence to provide ongoing automated behavior change coaching support to augment human-led care.
BACKGROUND: ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.

BACKGROUND: Low health literacy is costly and observed among justice-impacted adults (JIA), a group that often faces numerous barriers in accessing healthcare and a disproportionate burden of illness. Health literacy interventions for JIA are critically needed to improve healthcare access and related outcomes.
METHODS: This manuscript describes the protocol for a longitudinal mixed-methods randomized clinical trial that assesses the effectiveness of a coach-guided health literacy intervention on JIA\'s healthcare access. The intervention was previously piloted with justice impacted adults. We will recruit 300 JIA ages 18 + in San Diego, California. Participants will be randomized 1:1 to the Treatment Group (i.e., coach-guided intervention providing 12 sessions of individualized health coaching and service navigation over 6 months) or the Control Group (i.e., self-study of the health coaching program, and brief service navigation support). We will quantitatively assess JIA\'s healthcare access defined as: use of healthcare, health insurance status, and regular source of care at 6-months as the primary outcomes. Participants will also be surveyed at 12-months. Statistical analyses will incorporate the intent-to-treat (ITT) principle and we will estimate mixed-effects logistic regression for the primary outcomes. We will also conduct qualitative interviews at 6 and 12-months with 40 purposively sampled participants, stratified by study arm, who reported healthcare access barriers at baseline. Interviews will explore participants\' satisfaction with the intervention, healthcare attitudes, self-efficacy for and barriers to healthcare access over time, perceived contribution of the intervention to health and well-being, and diffusion of intervention-related information within participants\' social networks. We will conduct deductive thematic analyses of qualitative data.
CONCLUSIONS: Low health literacy among JIA is a foundational challenge requiring tailored intervention strategies. Findings from this trial may inform policies and the structure of service delivery models to build health literacy among JIA in institutional and community settings throughout the United States and elsewhere.
BACKGROUND: This study is registered with the United States\' ClinicalTrials.gov registry under protocol # 161,903.

BACKGROUND: Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes.
METHODS: The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS).
CONCLUSIONS: This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation.

OBJECTIVE: Healthy cancer survivorship involves patients\' active engagement with preventative health behaviors and follow-up care. While clinicians and patients have typically held dual responsibility for activating these behaviors, transitioning some clinician effort to technology and health coaches may enhance guideline implementation. This paper reports on the acceptability of the Shared Healthcare Actions & Reflections Electronic systems in survivorship (SHARE-S) program, an entirely virtual multicomponent intervention incorporating e-referrals, remotely-delivered health coaching, and automated text messages to enhance patient self-management and promote healthy survivorship.
METHODS: SHARE-S was evaluated in single group hybrid implementation-effectiveness pilot study. Patients were e-referred from the clinical team to health coaches for three health self-management coaching calls and received text messages to enhance coaching. Semi-structured qualitative interviews were conducted with 21 patient participants, 2 referring clinicians, and 2 health coaches to determine intervention acceptability (attitudes, appropriateness, suitability, convenience, and perceived effectiveness) and to identify important elements of the program and potential mechanisms of action to guide future implementation.
RESULTS: SHARE-S was described as impactful and convenient. The nondirective, patient-centered health coaching and mindfulness exercises were deemed most acceptable; text messages were less acceptable. Stakeholders suggested increased flexibility in format, frequency, timing, and length of participation, and additional tailored educational materials. Patients reported tangible health behavior changes, improved mood, and increased accountability and self-efficacy.
CONCLUSIONS: SHARE-S is overall an acceptable and potentially effective intervention that may enhance survivors\' self-management and well-being. Alterations to tailored content, timing, and dose should be tested to determine impact on acceptability and outcomes.

UNASSIGNED: One-third of the global population is predicted to be diagnosed with hypertension (HTN) in 2025, with the percentage highest among older people. Without proper self-care management, uncontrolled HTN causes negative health consequences and decreases the quality of life. The previous scoping review identified various challenges that older adults may face in dealing with HTN and that effective approaches should consider each individual\'s circumstances and attributes. This study aims to investigate the efficacy and sustainable impact of an Indonesian adaptation of an 8-week nurse health coaching intervention on self-care management and self-efficacy among older people with HTN.
UNASSIGNED: The coaching sessions will last for 30 min weekly for 8 weeks. The data will be measured at three points: baseline (initial), 1 week after the eighth health coaching session, and 3 months after concluding the intervention.
UNASSIGNED: This study will be the first health coaching intervention research based on motivational interviewing and cognitive behavioral therapy approach with Indonesian background adjustment. The study result will help develop a guideline for nurses and other health workers providing health coaching for older people in Indonesia and other countries with similar characteristics in terms of sociodemographics or lifestyle.
UNASSIGNED: thaiclinicaltrials.org Identifier: TCTR20230410001 (Date of registration: April 9, 2023).

A self-management intervention is a personalized approach to individuals aiming to engage individuals in a behavior change to develop skills to live better with their condition. Self-management involves an iterative process between participants and providers in which goals are formulated and feedback is given. All respiratory societies advocate self-management as part of chronic care because it may improve quality of life and health-care utilization. Self-management is an integral part of pulmonary rehabilitation. Self-management interventions usually involve education and exercise prescription, and that is an asset of current programs; however, recent reports indicate that effective strategies for motivation and a behavior change focus are often missed. A recent systematic review on self-management urges the need for a specific aspect and characteristic of self-management interventions: iterative interactions between participants and health-care professionals competent in using behavior change practices to elicit participants\' motivation, confidence, and competence to develop skills to better manage their disease. A recent review of self-care intervention in chronic disease states that the major deficits found in self-care interventions included a lack of attention and/or innovation to the psychological consequences of chronic illness, technology, and behavior change techniques to help patients manage symptoms. There is a need for exploration of mechanisms to explain the relationships between both anxiety and depression, and adherence to treatment in COPD. The latter is particularly appropriate for pulmonary rehabilitation, for which greater adherence is needed. This report aims to introduce basic aspects of behavior change and a proposed roadmap to introduce behavior change into pulmonary rehabilitation and chronic care programs.