Data and safety monitoring in social behavioral intervention trials: the REACH II experience

Background Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials. Purpose This paper summarizes how issues associated with safety monitoring and adverse event reporting were handled in the Resources for Enhancing Alzheimer\u27s Caregiver Health (REACH II) program, a multi-site randomized clinical trial, funded by the National Institutes on Aging (NIA) and the National Institutes of Nursing Research (NINR), that tested the efficacy of a multicomponent social/behavioral intervention for caregivers of persons with Alzheimer\u27s disease. Methods A task force was formed to define adverse events for the trial and protocols for reporting and resolving events that occurred. The task force conducted a review of existing polices and protocols for data and safety monitoring and adverse event reporting and identified potential risks particular to the study population. An informal survey regarding data and safety monitoring procedures with investigators on psychosocial intervention trials was also conducted. Results Two categories of events were defined for both caregivers and patients; adverse events and safety alerts. A distinction was also made between events detected at baseline assessment and those detected post-randomization. Standardized protocols were also developed for the reporting and resolution of events that occurred and training of study personnel. Results from the informal survey indicated wide variability in practices for data safety and monitoring across psychosocial intervention trials. Conclusions Overall, the REACH II experience demonstrates that existing guidelines regarding safety monitoring and adverse event reporting pose unique challenges for social/behavioral intervention trials. Challenges encountered in the REACH II program included defining and classifying adverse events, defining resolution of adverse events and attributing causes for events that occurred. These challenges are highlighted and recommendations for addressing them in future studies are discussed

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Integrating Caregiver Support into Multiple Sclerosis Care

With loss of mobility in Multiple Sclerosis (MS) comes increase in caregiver assistance, burden, stress, and depression. This 6-month feasibility study used a pre-post design to test integration of a validated, behavioral, caregiving intervention into an ongoing MS clinic. Because the program focused on caregivers, there were no additional services provided to the persons living with MS other than usual medical care. Twenty-five MS caregivers received REACH VA (Resources for Enhancing All Caregivers’ Health in the VA), a six-session behavior-focused intervention during two to three months designed to increase caregiver skills in managing their own stress and burden and MS related issues and concerns, with a focus on mobility. Caregivers were assessed at baseline, three, and six months. Caregivers’ expectations of the program were to receive education on MS, caregiving and stress management skills, and support. The major benefits caregivers reported were understanding their loved one’s condition and how to better provide care. At six months, caregivers reported statistically and clinically significant improvements in depressive symptoms and bother with challenging MS behaviors. Persons with MS reported benefit for their caregivers and for themselves; 71% reported that their caregivers had helped them with mobility and function. Study results suggest that the addition of the brief REACH caregiver intervention into an MS clinic would benefit both caregivers and persons with MS. Although the intervention was six sessions over three months, benefit persisted at six months, suggesting durability of effects. This trial is registered with ClinicalTrials.gov NCT02835677

Text Messages to Support Caregivers in a Health Care System: Development and Pilot and National Rollout Evaluation

BackgroundAlthough there are many interventions to support caregivers, SMS text messaging has not been used widely. ObjectiveIn this paper, we aimed to describe development of the Department of Veterans Affairs (VA) Annie Stress Management SMS text messaging protocol for caregivers of veterans, its pilot test, and subsequent national rollout. MethodsThe stress management protocol was developed with text messages focusing on education, motivation, and stress-alleviating activities based on the Resources for Enhancing All Caregivers Health (REACH) VA caregiver intervention. This protocol was then tested in a pilot study. On the basis of the pilot study results, a national rollout of the protocol was executed and evaluated. Caregivers were referred from VA facilities nationally for the pilot and national rollout. Pilot caregivers were interviewed by telephone; national rollout caregivers were sent a web-based evaluation link at 6 months. For both evaluations, questions were scored on a Likert scale ranging from completely disagree to completely agree. For both the pilot and national rollout, quantitative data were analyzed with frequencies and means; themes were identified from open-ended qualitative responses. ResultsOf the 22 caregivers in the pilot study, 18 (82%) provided follow-up data. On a 5-point scale, they reported text messages had been useful in managing stress (mean score 3.8, SD 1.1), helping them take care of themselves (mean score 3.7, SD 1.3), and making them feel cared for (mean score 4.1, SD 1.7). Texts were easy to read (mean score 4.5, SD 1.2), did not come at awkward times (mean score 2.2, SD 1.4), were not confusing (mean score 1.1, SD 0.2), and did not cause problems in responding (mean score 1.9, 1.1); however, 83% (15/18) of caregivers did not want to request an activity when stressed. Consequently, the national protocol did not require caregivers to respond. In the national rollout, 22.17% (781/3522) of the eligible caregivers answered the web-based survey and reported that the messages had been useful in managing stress (mean score 4.3, SD 0.8), helping them take care of themselves (mean score 4.3, SD 0.8) and loved ones (mean score 4.2, SD 0.8), and making them feel cared for (mean score 4.5, SD 0.8). Almost two-thirds (509/778, 65.4%) of the participants tried all or most of the strategies. A total of 5 themes were identified. The messages were appreciated, helped with self-care, and made them feel less alone, looking on Annie as a friend. The caregivers reported that the messages were on target and came when they were most needed and did not want them to stop. This success has led to four additional caregiver texting protocols: bereavement, dementia behaviors and stress management, (posttraumatic stress disorder) PTSD behaviors, and taking care of you, with 7274 caregivers enrolled as of February 2022. ConclusionsCaregivers reported the messages made them feel cared for and more confident. SMS text messaging, which is incorporated into clinical settings and health care systems, may represent a low-cost way to provide useful and meaningful support to caregivers

Smoking and smoking increase in caregivers of Alzheimer\u27s patients

Purpose of the Study: The relationship between stress and smoking has been established, but there is little research on the effects of stress and coping on smoking in caregivers of Alzheimer\u27s disease patients. This study examines how caregiver stressors and coping resources explain smoking status and recent smoking increase. Design and Methods: Data were obtained from the Resources for Enhancing Alzheimer\u27s Caregivers Health (REACH II) study. Analyses identified differences between caregiver smokers and nonsmokers and between caregiver smokers who reported a recent smoking increase and those who did not. Variables that were significantly different between the groups were examined in two logistic regression analyses to explain smoking status and smoking increase. Results: Of 642 caregivers, nearly 40% reported smoking and 25% of smokers reported recent increase in smoking. Younger caregivers were more likely to report smoking. Explanatory variables for smoking increase were being Caucasian or African-American, higher depression scores, and less caregiving skills. Implications: This study demonstrates that smoking among caregivers is a valid public health concern. Further investigation of ways that explanatory variables affect smoking status and increase in caregivers, and incorporation of smoking cessation strategies that address depression and low caregiving skills, seem warranted in future caregiver interventions

The cost-effectiveness of a behavior intervention with caregivers of patients with Alzheimer's disease

To examine the cost-effectiveness of a randomized, clinical trial of a home-based intervention for caregivers of people with dementia. This cost-effectiveness analysis examined Resources for Enhancing Alzheimer's Caregivers Health (REACH II), a multisite, randomized, clinical trial, from June 2002 through December 2004, funded by the National Institute on Aging and the National Institute of Nursing Research, of a behavioral intervention to decrease caregivers' stress and improve management of care recipient behavioral problems. Community-dwelling dementia caregiving dyads from the Memphis REACH II site. Of Memphis' random sample of 55 intervention and 57 control black and white dyads, 46 in each arm completed without death or discontinuation. Family caregivers were aged 21 and older, lived with the care recipient, and had provided 4 or more hours of care per day for 6 months or longer. Care recipients were cognitively and functionally impaired. Twelve individual sessions (9 home sessions and 3 telephone sessions) supplemented by five telephone support-group sessions. Control caregivers received two "check in" phone calls. Incremental cost-effectiveness ratio (ICER), the additional cost to bring about one additional unit of benefit (hours per day of providing care). At 6 months, there was a significant difference between intervention caregivers and control caregivers in hours providing care (P=.01). The ICER showed that intervention caregivers had 1 extra hour per day not spent in caregiving, at a cost of $5 per day. The intervention provided that most scarce of caregiver commodities--time. The emotional and physical costs of dementia caregiving are enormous, and this intervention was able to alleviate some of that cost