A Series of Personalized Virtual Light Therapy Interventions for Fatigue: Feasibility Randomized Crossover Trial for N-of-1 Treatment.

BACKGROUND: Fatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants. METHODS: Participants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants. RESULTS: Participants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=-1.63, 95% CI -2.63 to -0.63) and DL (B=-1.44, 95% CI -2.50 to -0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms. CONCLUSIONS: The participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846.

The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol.

BACKGROUND: In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. However, studies have also indicated that up to 60% of the estimated 26.8 million Americans prescribed primary prevention statin treatment are nonadherent during the first year. Multi-component behavioral change technique (BCT) therapies have shown moderate promise in improving medication adherence as well as other positive health behaviors (such as physical activity). However, no research has looked at the duration of multi-component BCT intervention needed to result in a clinically significant improvement in statin adherence behaviors. This study aims to determine the necessary dose of a multi-component BCT intervention (defined as duration in weeks) to promote adherence to statin medication among those on primary prevention statin treatment by utilizing the modified time-to-event continuous reassessment method (TiTE-CRM). METHODS AND DESIGN: The study will utilize the modified TiTE-CRM in 42 participants, recruited in 14 cohorts of 3 participants each. The goal of this analysis is to identify the minimum effective dose (MED) of a multi-behavior change technique (BCT) intervention required to increase adherence to statins by 20% between baseline and follow-up periods. Using the TiTE-CRM method, the dose of the behavior intervention in weeks will be assigned to each cohort based on the performance of the prior cohort. At the end of the study, the intervention dose that has been found to be associated with a 20% increase in statin adherence among 80% of participants assigned to that dose will be identified as the MED. DISCUSSION: If successful, the current trial will provide additional guidance to researchers and clinicians seeking to increase statin medication adherence using a BCT intervention by identifying the dose (i.e., the duration) of an intervention required to meaningfully increase adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www. CLINICALTRIALS: gov/ct2/show/NCT05273736.

The effect of a multi-component behavior change technique intervention on physical activity among individuals on primary prevention statin therapy: A dose-finding trial protocol.

BACKGROUND: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA. OBJECTIVE: The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD). METHODS: The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions. ETHICS AND DISSEMINATION: This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines. REGISTRATION DETAILS: This trial is registered on www. CLINICALTRIALS: gov (Number NCT05273723).

Implementation outcomes and strategies for delivering evidence-based hypertension interventions in lower-middle-income countries: Evidence from a multi-country consortium for hypertension control.

Guidance on contextually tailored implementation strategies for the prevention, treatment, and control of hypertension is limited in lower-middle income countries (Lower-MIC). To address this limitation, we compiled implementation strategies and accompanying outcomes of evidence-based hypertension interventions currently being implemented in five Lower-MIC. The Global Research on Implementation and Translation Science (GRIT) Coordinating Center (CC) (GRIT-CC) engaged its global network sites at Ghana, Guatemala, India, Kenya, and Vietnam. Purposively sampled implementation science experts completed an electronic survey assessing implementation outcomes, in addition to implementation strategies used in their ongoing hypertension interventions from among 73 strategies within the Expert Recommendations for Implementing Change (ERIC). Experts rated the strategies based on highest priority to their interventions. We analyzed the data by sorting implementation strategies utilized by sites into one of the nine domains in ERIC and summarized the data using frequencies, proportions, and means. Seventeen implementation experts (52.9% men) participated in the exercise. Of Proctor's implementation outcomes identified across sites, all outcomes except for appropriateness were broadly assessed by three or more countries. Overall, 59 out of 73 (81%) strategies were being utilized in the five countries. The highest priority implementation strategies utilized across all five countries focused on evaluative and iterative strategies (e.g., identification of context specific barriers and facilitators) to delivery of patient- and community-level interventions, while the lowest priority was use of financial and infrastructure change strategies. More capacity building strategies (developing stakeholder interrelationships, training and educating stakeholders, and supporting clinicians) were incorporated into interventions implemented in India and Vietnam than Ghana, Kenya, and Guatemala. Although robust implementation strategies are being used in Lower -MICs, there is minimum use of financial and infrastructure change strategies. Our study contributes to the growing literature that demonstrates the use of Expert Recommendations for Implementing Change (ERIC) implementation strategies to deliver evidence-based hypertension interventions in Lower-MICs and will inform future cross-country data harmonization activities in resource-constrained settings.

Cardiovascular Disease and Mortality in Adults Aged ≥60 Years According to Recommendations by the American College of Cardiology/American Heart Association and American College of Physicians/American Academy of Family Physicians.

In 2017, the American College of Cardiology/American Heart Association (ACC/AHA) and the American College of Physicians/American Academy of Family Physicians (ACP/AAFP) published blood pressure guidelines. Adults recommended antihypertensive medication initiation or intensification by the ACP/AAFP guideline receive the same recommendation from the ACC/AHA guideline. However, many adults ≥60 years old are recommended to initiate or intensify antihypertensive medication by the ACC/AHA but not the ACP/AAFP guideline. We compared atherosclerotic cardiovascular disease event rates according to antihypertensive treatment recommendations in the ACC/AHA and ACP/AAFP guidelines among adults ≥60 years old with systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥80 mm Hg in the REGARDS study (Reasons for Geographic and Racial Differences in Stroke) and the JHS (Jackson Heart Study). Among 4311 participants not taking antihypertensive medication at baseline, 11.4%, 61.2%, and 27.4% were recommended antihypertensive medication initiation by neither guideline, the ACC/AHA but not the ACP/AAFP guideline, and both guidelines, respectively. Atherosclerotic cardiovascular disease event rates (95% CI) for these groups were 3.4 (1.6-5.2), 18.0 (16.1-19.8), and 25.3 (21.9-28.6) per 1000 person-years, respectively. Among 7281 participants taking antihypertensive medication at baseline, 57.9% and 42.1% were recommended antihypertensive medication intensification by the ACC/AHA but not the ACP/AAFP guideline and both guidelines, respectively. Atherosclerotic cardiovascular disease event rates (95% CI) for these groups were 18.2 (16.7-19.7) and 33.0 (30.5-35.4) per 1000 person-years, respectively. In conclusion, adults recommended initiation or intensification of antihypertensive medication by the ACC/AHA but not the ACP/AAFP guideline have high atherosclerotic cardiovascular disease risk that may be reduced through treatment initiation or intensification.

Medication Adherence Improvement Similar for Shared Decision-Making Preference or Longer Patient-Provider Relationship.

BACKGROUND: While increasing evidence supports the beneficial effects of shared decision making (SDM) on patient outcomes, the mechanisms underlying this relationship is unclear. This study evaluated length of the patient-provider relationship as one potential factor that may explain how SDM affects medication adherence in patients with hypertension. METHODS: An observational study of 75 hypertensive patients and 27 providers in 3 primary care practices in New York City. A single-item measure assessed patients' preferences for decision-making style at baseline; medication adherence was collected over the 3-month study with an electronic monitoring device. Length of the relationship was measured as the number of years with the provider, and dichotomized as less than or greater than 1 year with the provider. Two generalized linear mixed models were conducted to determine whether the SDM-adherence association was modified by length of the relationship. RESULTS: Most patients were Black and women, and 64% were seeing the same provider >1 year. Providers were mostly White women and have been at the clinic for 6 years. In the main-effects model, patients were more likely to exhibit better adherence when they preferred shared and active decision-making styles as compared with those who preferred a passive style (B = 15.87 [Standard Error [SE]: 6.62], P = .02; and B = 22.58 [SE:7.62], P = .004, respectively). In Model 2, the relative importance of SDM on adherence decreased as years with the provider increased (t(48) = 2.13; P = .04). CONCLUSION: The benefits of SDM over passive decision making on medication adherence were reduced with increasing years of the patient-provider relationship. Having an established relationship with the provider may have a positive impact on medication adherence that is comparable to relationships high in SDM.

The effect of proxy voice intervention on couple softening in the context of enactments.

In this study we evaluated the effectiveness of proxy voice (therapist acting as client's "voice") intervention, embedded within couple enactments, on client-perceived softening. The primary research question was whether use of proxy voice would be more likely to bring about softening, or if its use was counterintuitive to enactment conceptualization and would elicit struggle behavior (e.g., withdrawal or negativity). Results indicate that proxy voice has a significant, positive association with softening and is inversely related to withdrawal or negativity. Preliminary findings suggest that proxy voice intervention embedded within a fluid, carefully delineated, and discriminating model of enactments effectively facilitates essential elements of couple interaction (expression of primary affect and articulation of self-concept and attachment threats) while promoting self-reliant couple interaction and increased softening.

Attachment Change in the Beginning Stages of Therapy: Examining Change Trajectories for Avoidance and Anxiety.

The purpose of this study was to investigate the nature of self-reported attachment change (avoidance and anxiety) in the context of six sessions of couple therapy designed to emphasize both therapist-centered and couple-centered (i.e., enactment-based) clinical process during the beginning stages of therapy. A total of 48 couples with at least one partner who reported clinically significant relationship dissatisfaction participated in this study. Findings confirmed that some couples experience positive attachment-related change (anxiety or avoidance), while also identifying a subset of individuals who may not experience optimal levels of attachment-related change. In addition, findings point toward both differences and similarities between change trajectories for avoidance and anxiety. Finally, there was evidence that socio-demographic factors may be associated with attachment change.

Concerted diurnal patterns in riverine nutrient concentrations and physical conditions.

Several long-term sets of hourly nitrate concentration data were obtained through deployment of a nitrate sensor in an upper reach of the River Taw, a small moorland-fed river in the South West of the UK. Examination of the data obtained during periods of low flow and the absence of rainfall in the catchment revealed the presence of marked diurnal cycles, which were in concert and negatively correlated with diurnal cycles in water temperature. After verifying that these cycles were natural, an intensive 90-h field monitoring campaign was conducted, in which river water was sampled hourly and immediately analysed in the laboratory for molybdate-reactive phosphorus (P), nitrate, nitrite, ammonium, and pH. Coincident measurements of water temperature, river discharge and solar energy were also taken at, or close to, the site. All measurements revealed diurnal patterns and all patterns were concerted. The cycles of P, nitrate, nitrite, and discharge had two maxima and minima per 24 h, while the cycle of water temperature had one, with a maximum at 20.00 and a minimum at 08.00. The amplitudes of the cycles of P and nitrate were each about 30% of the mean values, while the amplitude of the nitrite cycle was as great as 80% of the mean value on occasions. Both biological and physical mechanisms for the cycling could operate through water temperature and/or incident radiation to account for the observed phenomenon, but there remains uncertainty of which is the more important. The observations have important implications for both the accuracy of pollution assessment in rivers and the physiological rhythms of riverine organisms.