"And Does That Necessarily Mean Absolutely Alzheimer's?" An Analysis of Questions Raised Following Amyloid PET Results Disclosure.

INTRODUCTION: Amyloid PET scans provide individuals with mild cognitive impairment (MCI) information about their risk of progressing to Alzheimer's dementia (AD). Given the wide-ranging implications of this information, best practice guidelines are needed to support researchers and clinicians disclosing these high-stakes test results. To inform the development of such guidelines, this analysis aims to describe questions and concerns raised during the disclosure of amyloid PET results in the context of MCI. METHODS: Qualitative description was performed to analyze (n = 34) transcripts of audio-recorded amyloid PET results disclosure sessions involving MCI care dyads. The analysis focused on characterizing the frequency and nature of questions raised during an open question-and-answer (Q&A) period following the return of scan results using a standardized protocol. RESULTS: Nearly all (n = 32/34) dyads posed questions during Q&A. Questions fell within six main categories with the most common being requests for clarification regarding AD/MCI, and next steps given the result. Questions were interspersed with comments reflecting the need for emotional support. Independently administered assessments of comprehension of results showed that, following the disclosure and Q&A, 31/32 participants with MCI and 31/31 care partners scored ≥4 on a 5-point scale. The number of questions asked by care partners during Q&A positively correlated with their level of comprehension (n = 31, Spearman's r = 0.370, p = 0.040). DISCUSSION: This analysis highlights the value of providing opportunities for patients and their family members to ask questions upon learning patients' brain amyloid status. Disclosing clinicians should be prepared to provide clarification, resources, and support to patients and families during the return of amyloid PET results.

Nurse-led pre-test counseling for Alzheimer's disease biomarker testing: Knowledge and skills required to meet the needs of patients and families.

INTRODUCTION: Biomarker testing for Alzheimer's disease and related disorders (ADRD) brings new opportunities for nurses to foster shared decision-making by leading pre-test counseling (PTC) for patients and families. METHODS: Audio-recordings of 18 nurse-led PTC sessions were analyzed to characterize questions posed by patient and family members dyads considering whether to pursue amyloid positron emission tomography. RESULTS: Sessions lasted 20 to 75 minutes and generated rich discussion of the purpose and potential implications of amyloid imaging. Dyads posed questions regarding: basic neuroanatomy; the spectrum of normal cognitive aging to dementia; clinical phenotypes and pathological hallmarks of ADRD; secondary prevention of ADRD; and advance planning. In response, PTC facilitators provided disease-specific education, clarification of overt misconceptions, caregiver support, and emotion de-escalation. CONCLUSION: Nurses conducting PTC for AD biomarker testing should be equipped to answer questions about topics both directly and indirectly related to testing, and also provide emotional support.

Mechanisms by Which Cultural-Centric Narrative Influences Interest in ADRD Research Among African American Adults.

BACKGROUND AND OBJECTIVES: Insufficient ethnoracial diversity is a pervasive challenge in Alzheimer's disease (AD) research. The Recruitment Innovations for Diversity Enhancement (RIDE) is grounded in the premise that culturally informed narratives of research participation can inspire individuals from a given culture-sharing group to consider research enrollment. This study examines factors associated with interest in AD research among Black or African American adults following exposure to RIDE narrative campaign materials. RESEARCH DESIGN AND METHODS: A community-based sample of 500 Black or African American adults viewed RIDE narrative materials online and completed a survey of perceptions about research, AD risk, and likelihood of enrolling in AD research. Logistic regression examined predictors and mediators of self-reported likelihood of participating in AD research. RESULTS: Most (72%) participants reported interest in being contacted for AD research opportunities. After controlling for key variables, prior experience with clinical research and trust in medical researchers emerged as independent predictors of likelihood of enrolling in AD research. Perceived burden of AD research partially mediated the effects of prior research experience and trust on likelihood of enrollment. Perceived benefits of AD research also played a mediating role, accounting for over one third of the effect of trust on likelihood of enrollment. DISCUSSION AND IMPLICATIONS: This study advances the field's understanding of how narrative may function to enhance diversity in AD research. Findings suggest that participant narratives should address experiences regarding the burdens and potential benefits of AD research participation as these factors may influence decisions leading to subsequent research enrollment.

Cognitive Behavioral Therapy (CBT) Telehealth Augmented With a CBT Smartphone Application to Address Type 2 Diabetes Self-Management: A Randomized Pilot Trial.

PURPOSE: The purpose of the study was to investigate the feasibility and acceptability of phone-delivered cognitive behavioral therapy (CBT) combined with an adjunctive smartphone application CBT MobileWork-DM© to improve self-management of type 2 diabetes mellitus (T2DM). METHODS: Participants were 12 patients with T2DM on antihyperglycemic medication and had an A1C level of 8 or greater. A randomized controlled pilot study assessed treatment as usual (TAU) T2DM care versus a phone-delivered CBT (6, 8, or 12 weekly sessions) augmented with a CBT skills practice smartphone application. The CBT telehealth intervention addressed T2DM self-management and diabetes distress. Electronic and self-report medication taking, diabetes-related distress, and A1C were assessed at baseline and post-intervention. RESULTS: After 16 weeks, a decrease in A1C and distress levels was observed in all 3 CBT phone groups and TAU group. The group with the most improvement was the 12-week CBT group, which had the greatest mean decrease in A1C (-2.33) and diabetes distress (-31.67). The TAU group exhibited a mean decrease of -2.15 and -21 for A1C and diabetes distress, respectively. The overall rate of completion for phone CBT sessions across the 3 CBT groups was 83%. CONCLUSION: This study demonstrates that telehealth CBT augmented with a smartphone application is feasible and acceptable. Patients demonstrated improvements in both T2DM management and distress.

Framework for creating storytelling materials to promote African American/Black adult enrollment in research on Alzheimer's disease and related disorders.

INTRODUCTION: African American/Black adults are severely underrepresented in basic, clinical, and behavioral research studies in Alzheimer's disease and related disorders (ADRD). Innovative, evidence-based, and culturally salient strategies can maximize the recruitment of African American/Black adults into ADRD research. METHODS: We conducted and analyzed semi-structured interviews to capture the research participation stories of African American/Black participants and study partners from the University of Pittsburgh's Alzheimer's Disease Research Center. The themes and messaging principles generated through this process informed the development of video- and text-based materials that were evaluated for community member acceptance using focus groups. RESULTS: Focus group individuals (N = 36) generally favorably rated the video and text materials, characterizing them as "interesting," "realistic," and "convincing." DISCUSSION: Capturing the narratives of African American/Black research participants is a critical component to developing culturally relevant materials for broader dissemination and is essential to advancing beyond information-only recruitment approaches, which tend to rely disproportionately on negative messages.

A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment.

INTRODUCTION: Recent studies suggest that Alzheimer's disease (AD) biomarker disclosure has no discernable psychological impact on cognitively healthy persons. Far less is known about how such results affect symptomatic individuals and their caregivers. METHODS: Randomized controlled trial of 82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164) to determine the effect of receiving amyloid positron emission tomography results on understanding of, and perceived efficacy to cope with, MCI over 52 weeks of follow-up. RESULTS: Gains in the primary outcomes were not consistently observed. Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive. There was no corresponding increase in depressive symptoms. DISCUSSION: These findings point to the possibility that both MCI patients and caregivers may need emotional support after the disclosure of amyloid scan results.

Research Use of Ecological Momentary Assessment for Adverse Event Monitoring Following Amyloid-ß Results Disclosure.

As calls for transparency in human subjects research grow, investigators conducting Alzheimer's disease (AD) biomarker research are increasingly required to consider their ethical obligations regarding the return of AD biomarker test results to research participants. When disclosing these test results to potentially vulnerable participants, investigators may face unique challenges to identify adverse events, particularly psychological events. The purpose of this paper is to describe our research team's experience with developing and implementing a process for enhanced adverse event monitoring following the return of amyloid-ß (Aß) imaging results to research participants with mild cognitive impairment (MCI). Ethical and logistical considerations are presented along with preliminary findings from an ongoing randomized controlled trial of Aß imaging results disclosure in MCI. Following receipt of amyloid imaging results, participants underwent 14 days of adverse event monitoring using ecological momentary assessment (EMA), a strategy to capture health, behaviors, and mood as they occur in participants' natural settings in real time. EMA telephone calls were placed at random during waking hours to screen for mood changes. Investigators were alerted for positive depression, anxiety, suicidal ideation screenings, or for two days of failed call attempts. Preliminary feasibility of twenty-four participants with MCI who participated in EMA mood assessments was successfully completed 83% (SD = 0.4) of the time over 14 days with no alerts for anxiety or depression screening items. EMA, when used with standard adverse event monitoring, is a promising and novel approach to maximize early detection of negative psychological reactions following AD biomarker results disclosed in research settings.

Outcomes of a Problem-Solving Medication Management Intervention for Informal Caregivers.

Older adults with memory loss often require assistance from caregivers to manage their medications. This study examined the efficacy of a problem-solving-based intervention focused on caregiver medication management, problem solving, self-efficacy, and daily hassles. Caregiver health-related quality of life (HRQoL) and patient health care utilization were secondary outcomes. Totally, 83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5%) were randomized; data collection occurred at baseline, 8, 16, and 24 weeks. Linear mixed modeling showed significant decreases in medication deficiencies which were sustained over time. No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time. In addition, caregiver self-efficacy and mental HRQoL decreased in both groups. Physical HRQoL decreased in the intervention group, yet increased in the usual care group. Future research should investigate these outcomes in larger and more diverse samples.

Use of a Self-Report Medication Adherence Scale for Measuring Adherence to Antiretroviral Therapy in Patients With HIV/AIDS.

BACKGROUND AND PURPOSE: This study examined the psychometric properties of a 9-item Morisky Medication Adherence Scale (MMAS-9) adapted specifically for patients with HIV/AIDS. METHODS: We used data from two randomized controlled trials investigating telephone-delivered interventions for improving adherence to antiretroviral therapy to assess reliability (Cronbach's α and Pearson's product correlation) and validity (convergent and concurrent) of the MMAS-9. RESULTS: The internal consistency (Cronbach's α) of the MMAS-9 was .66 (study 1) and .69 (study 2); 3-month test-retest reliability (Pearson's correlation) ranged from .50 to .74. Validity was supported by associations with electronic event monitored adherence, social support, depressive symptoms, self-efficacy, stigma, regimen complexity, and impact of side effects in the hypothesized direction. CONCLUSIONS: The adapted MMAS-9 demonstrated good convergent validity but somewhat lower internal consistency reliability than other reports.

Health literacy and its correlates in informal caregivers of adults with memory loss.

This secondary analysis examined health literacy among informal caregivers of community-dwelling older adults with memory loss and assessed correlates of caregiver health literacy using the Abilities, Skills and Knowledge Model. Caregiver health literacy (n = 91) was assessed by the Newest Vital Sign. Limited health literacy presented in 38.5% caregivers, with significantly low document literacy. Health literacy was associated bivariately with age, education, global cognitive function, executive function, and working memory (all ps < 0.001), as well as medication knowledge (p = 0.015). Hierarchical regression analyses revealed that older age (p = 0.017), and lower global cognitive function (p < 0.001), working memory (p = 0.001), and academic skills (years of education) (p = 0.004), independently predicted lower health literacy (R2 = 0.54). Medication knowledge, however, was not found to be an independent predictor in the model. Findings suggest limited health literacy is a potential issue among informal caregivers of adults with memory loss. Appropriate assessment and personalized support are needed for informal caregivers who are at high risk for poor health literacy.

An intervention to maximize medication management by caregivers of persons with memory loss: Intervention overview and two-month outcomes.

Overseeing medication-taking is a critical aspect of dementia caregiving. This trial examined a tailored, problem-solving intervention designed to maximize medication management practices among caregivers of persons with memory loss. Eighty-three community-dwelling dyads (patient + informal caregiver) with a baseline average of 3 medication deficiencies participated. Home- and telephone-based sessions were delivered by nurse or social worker interventionists and addressed basics of managing medications, plus tailored problem solving for specific challenges. The outcome of medication management practices was assessed using the Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE) and an investigator-developed Medication Deficiency Checklist (MDC). Linear mixed modeling showed both the intervention and usual care groups had fewer medication management problems as measured by the MedMaIDE (F = 6.91, p < .01) and MDC (F = 9.72, p < .01) at 2 months post-intervention. Reduced medication deficiencies in both groups suggests that when nurses or social workers merely raise awareness of the importance of medication adherence, there may be benefit.

Stressors and Caregivers' Depression: Multiple Mediators of Self-Efficacy, Social Support, and Problem-Solving Skill.

Caring for an older adult with memory loss is stressful. Caregiver stress could produce negative outcomes such as depression. Previous research is limited in examining multiple intermediate pathways from caregiver stress to depressive symptoms. This study addresses this limitation by examining the role of self-efficacy, social support, and problem solving in mediating the relationships between caregiver stressors and depressive symptoms. Using a sample of 91 family caregivers, we tested simultaneously multiple mediators between caregiver stressors and depression. Results indicate that self-efficacy mediated the pathway from daily hassles to depression. Findings point to the importance of improving self-efficacy in psychosocial interventions for caregivers of older adults with memory loss.

Assessing usual care in clinical trials.

Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in Multisite Adherence Collaboration in HIV (MACH 14), a multisite collaboration on adherence to antiretroviral therapy. Only five of the studies in MACH 14 assessed usual care. Assessment protocols varied as did the timing and frequency of assessments. All usual care assessments addressed patient education focused on HIV, HIV medications, and medication adherence. Our findings support earlier work that calls for systematic assessments of usual care within the study design, inclusion of descriptions of usual care in reports of the study, and the influence of usual care on the experimental condition in clinical trials.

Characterizing caregiver-mediated medication management in patients with memory loss.

Increasingly, family members are assisting with the complex task of medication management when patients are experiencing cognitive decline. To date, limited published research addresses caregiver-mediated medication management of patients with impaired cognition. Thus, the purpose of this study was to describe the characteristics and correlates of caregiver-mediated medication management in community-dwelling patients with memory loss. We used baseline data from the 91 patient-caregiver dyads participating in a randomized controlled trial designed to assist caregivers of patients with memory loss with medication management. The patient's level of cognitive impairment was not related to medication errors; however, the number of medications that patients were prescribed and taking was related to medication errors. Important factors to consider when discussing medication management with caregivers of patients with memory loss include the caregiver's age, cognitive ability, and depressive symptoms, as well as the caregiver's perception of the impact of the patient's behavioral problems.

Assessing fidelity to an intervention in a randomized controlled trial to improve medication adherence.

BACKGROUND: Behavioral intervention effectiveness in randomized controlled trials requires fidelity to the protocol. Fidelity assessment tools tailored to the intervention may strengthen intervention research. OBJECTIVE: The aim of this study was to describe the assessment of fidelity to the structured intervention protocol in an examination of a nurse-delivered telephone intervention designed to improve medication adherence. METHODS: Fidelity assessment included random selection and review of approximately 10% of the audiorecorded intervention sessions, stratified by interventionist and intervention session. Audiotapes were reviewed along with field notes for percentage of agreement, addressing whether key components were covered during the sessions. Visual analog scales were used to provide summary scores (0 = low to 5 = high) of interaction characteristics of the interventionists and participants with respect to engagement, demeanor, listening skills, attentiveness, and openness. RESULTS: Four nurse interventionists delivered 871 structured intervention sessions to 113 participants. Three trained graduate student researchers assessed 131 intervention sessions. The mean percentage of agreement was 92.0% (±10.5%), meeting the criteria of 90% congruence with the intervention protocol. The mean interventionist interaction summary score was 4.5 ± 0.4, and the mean participant interaction summary score was 4.5 ± 0.4. DISCUSSION: Overall, the interventionists successfully delivered the structured intervention content, with some variability in both the percentage of agreement and quality of interaction scores. Ongoing assessment aids in ensuring fidelity to study protocol and having reliable study results.