Pressure Injury Data Reconciliation in a Randomized Controlled Trial.

OBJECTIVE: To advance pressure injury (PrI) research in individuals with spinal cord injury (SCI) by describing lessons learned and recommendations for future research, ultimately promoting PrI prevention and more effective wound care. This paper describes the detailed procedures undertaken to collect and reconcile PrI data and summarizes the types of discrepancies identified. DESIGN: Secondary analyses of PrI data collected between 2009 and 2014 in a randomized controlled trial (parent study). SETTING: Participants in the parent study were recruited from a large rehabilitation center in the Los Angeles area that serves primarily individuals with limited resources. PARTICIPANTS: 232 participants with SCI and a history of 1 or more medically serious PrI (MSPrI) in the previous 5 years. INTERVENTIONS: Participants in the parent study were randomized to a 12-month PrI prevention intervention led by an occupational therapist, or to usual care. MAIN OUTCOME MEASURES: Relations among PrI characteristics, data sources (phone interviews, skin checks, paper and electronic medical records [MRs]), and treatment condition, and sensitivity of 6 different data sources in detecting MSPrIs. RESULTS: The majority (62%) of MSPrIs were in the pelvic region. MRs detected 82% of the MSPrIs overall, making it the most sensitive data source, and scheduled skin checks were the second-most sensitive data source, finding 37% of the MSPrIs. CONCLUSIONS: MR review is the preferred method for ascertaining MSPrIs in clinical trials of interventions designed to reduce the incidence of these injuries. When multiple sources of information are used, careful reconciliation of reports is necessary to ensure accuracy.

Long-Term Follow-Up of a Lifestyle Intervention for Late-Midlife, Rural-Dwelling Latinos in Primary Care.

IMPORTANCE: Rural-dwelling Latinos are an underresourced population in need of accessible and effective wellness programs. OBJECTIVE: To evaluate patients' long-term health-related outcomes after lifestyle intervention. DESIGN: An uncontrolled pilot trial assessing change in health from pretreatment to long-term follow-up (12 mo after intervention completion, no contact) and from posttreatment to long-term follow-up. SETTING: Rural, community-based primary care. PARTICIPANTS: Latino and Hispanic safety-net primary care patients, ages 50 to 64 yr. INTERVENTION: A culturally tailored, 4-mo lifestyle intervention co-led by occupational therapy practitioners and Latino community health workers that features telehealth and in-home sessions covering topics such as healthy eating and navigating health care. OUTCOMES AND MEASURES: Self-reported and physiological outcomes: symptom-well-being (primary), stress, sleep disturbance, social satisfaction, physical activity, patient activation, blood pressure, and weight. Exit interviews addressed health experiences and intervention impact on participants' lives. RESULTS: Participants (N = 27) demonstrated clinically significant pretreatment to long-term follow-up benefits in all symptom-well-being dimensions (Cohen's d ≥ 0.8, p ≤ .004), with additional gains from posttreatment to long-term follow-up (d ≥ 0.4, p ≤ .05). Significant improvements from pre- to posttreatment in systolic blood pressure, stress, and social role and activity satisfaction were maintained at long-term follow-up. No changes were observed in weight, physical activity, or diastolic blood pressure. Participants described the intervention's sustained positive effect on their wellness. CONCLUSIONS AND RELEVANCE: A lifestyle intervention led by occupational therapy practitioners and community health workers in a primary care context has potential to achieve long-term health benefits in rural-dwelling, late-midlife Latinos. WHAT THIS ARTICLE ADDS: This study reveals that rural, late-midlife Latinos showed long-lasting improvements in psychological and physical health after finishing a program that helped them make healthy lifestyle choices. This finding supports the unique contribution of occupational therapy in primary care settings.

Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.

BACKGROUND/AIMS: Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients. METHODS: Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features. RESULTS: In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. CONCLUSIONS: Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.

Contextualizing the Positive Effects of the Well Elderly 2 Trial: A Response to Schelly and Ohl (2019).

IMPORTANCE: A recent reanalysis of data from the Well Elderly (WE) 2 study purportedly indicated that the intervention did not achieve clinically meaningful or statistically significant effects; this article addresses these criticisms. OBJECTIVE: To contextualize the WE 2 study as targeting a nonclinical population and demonstrate that the intervention produced substantively important, statistically significant effects. DESIGN: Secondary analysis of WE 2 intervention-based pre-post change scores. SETTING: The original trial occurred primarily in senior centers and senior housing facilities in greater Los Angeles. PARTICIPANTS: Independent-living older adults (N = 324) who were assessed before and after intervention. INTERVENTION: The WE intervention, a version of the Lifestyle Redesign® (LR) approach, was administered by occupational therapists over 6 mo by means of group and individual sessions. OUTCOMES AND MEASURES: The 36-item Short Form Health Survey, the Life Satisfaction Index-Z, and the Center for Epidemiologic Studies Depression Scale. RESULTS: The WE intervention was associated with statistically significant improvement on 10 of 12 outcome variables that were examined. CONCLUSIONS AND RELEVANCE: Because the WE intervention was hypothesized to reduce age-related decline and followed a population-oriented approach, the expectation that average results would be clinically meaningful was inappropriate. The intervention produced positive effects across a wide array of outcome domains. In settings in which clinical meaningfulness is an appropriate index of intervention outcomes, evidence suggests that LR produces effects that are clinically meaningful. As an evidence-based intervention, LR should be considered useful both in population-oriented contexts and in addressing discrete health conditions. WHAT THIS ARTICLE ADDS: Valid analyses demonstrate that the positive experimental effects of the WE 2 study are, in fact, genuine and cost-effective, and LR in clinically oriented contexts has produced statistically significant, clinically meaningful results. Clearly and accurately representing the evidence base of occupational therapy in prevention and chronic care is of critical importance to advance the field as a whole.

Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign® Occupational Therapy.

IMPORTANCE: Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy's feasibility and efficacy in primary care settings. OBJECTIVE: To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign® (LR)-occupational therapy (LR-OT) diabetes management intervention in a primary care clinic. DESIGN: Patients were randomized to be offered LR-OT or to a no-contact comparison group (data not reported). We assessed implementation outcomes using mixed methods. SETTING: Safety-net primary care clinic. PARTICIPANTS: Clinic providers and staff; English- or Spanish-speaking clinic patients ages 18-75 yr with diabetes and a current hemoglobin A1c (HbA1c) ≥ 9.0%. INTERVENTION: Eight 1-hr individual sessions of LR-OT focused on diabetes management. OUTCOMES AND MEASURES: Clinical and health behavior outcomes were assessed via electronic medical record (EMR) review and self-report surveys of patients receiving LR-OT at initial evaluation and discharge. We assessed implementation outcomes (acceptability, appropriateness, feasibility, fidelity, efficiency, and timeliness) using patient and staff surveys, interviews, focus groups, and observations. RESULTS: Seventy-three patients were offered LR-OT: 51 completed one or more sessions, and 38 completed the program. Clinical outcomes among program completers indicate beneficial changes in HbA1c, diabetes self-care, and health status. Implementation challenges included a need for patient and staff education, securing adequate workspace, and establishing a referral process. Factors contributing to implementation success included strong buy-in from clinic leadership, colocation, and shared EMR documentation. CONCLUSIONS AND RELEVANCE: LR-OT is a feasible approach to enhancing service delivery and clinical outcomes in primary care. WHAT THIS ARTICLE ADDS: This study provides insight into factors that may create challenges or contribute to the success of implementing occupational therapy services within primary health care settings. In addition, this study provides preliminary evidence of occupational therapy's effectiveness in improving clinical outcomes among ethnically diverse, low-income patients with diabetes in a safety-net primary care setting.

Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury.

OBJECTIVE: To investigate the efficacy of behavioral or educational interventions in preventing pressure ulcers in community-dwelling adults with spinal cord injury (SCI). DATA SOURCES: Cochrane, Clinical Trials, PubMed, and Web of Science were searched in June 2016. The search combined related terms for pressure ulcers, spinal cord injury, and behavioral intervention. Each database was searched from its inception with no restrictions on year of publication. REVIEW METHODS: Inclusion criteria required that articles were (a) published in a peer-reviewed journal in English, (b) evaluated a behavioral or educational intervention for pressure ulcer prevention, (c) included community-dwelling adult participants aged 18 years and older with SCI, (d) measured pressure ulcer occurrence, recurrence, or skin breakdown as an outcome, and (e) had a minimum of 10 participants. All study designs were considered. Two reviewers independently screened titles and abstracts. Extracted information included study design, sample size, description of the intervention and control condition, pressure ulcer outcome measures, and corresponding results. RESULTS: The search strategy yielded 444 unique articles of which five met inclusion criteria. Three were randomized trials and two were quasi-experimental designs. A total of 513 participants were represented. The method of pressure ulcer or skin breakdown measurement varied widely among studies. Results on pressure ulcer outcomes were null in all studies. Considerable methodological problems with recruitment, intervention fidelity, and participant adherence were reported. CONCLUSIONS: At present, there is no positive evidence to support the efficacy of behavioral or educational interventions in preventing pressure ulcer occurrence in adults with SCI.

Napping and Nighttime Sleep: Findings From an Occupation-Based Intervention.

OBJECTIVE: To describe sleeping behaviors and trends over time among an ethnically diverse group of community-living older adults. METHOD: A descriptive secondary data analysis of a subsample (n = 217) from the Lifestyle Redesign randomized controlled trial was done to explore baseline napping and sleeping patterns as well as 6-mo changes in these outcomes. RESULTS: At baseline, the average time sleeping was 8.2 hr daily (standard deviation = 1.7). Among all participants, 29% reported daytime napping at baseline, of which 36% no longer napped at follow-up. Among participants who stopped napping, those who received an occupation-based intervention (n = 98) replaced napping time with nighttime sleep, and those not receiving an intervention (n = 119) experienced a net loss of total sleep (p < .05). CONCLUSION: Among participants who stopped napping, the occupation-based intervention may be related to enhanced sleep. More research examining the role of occupation-based interventions in improving sleep is warranted.

Lifestyle changes and pressure ulcer prevention in adults with spinal cord injury in the pressure ulcer prevention study lifestyle intervention.

Pressure ulcers (PrUs) are a major burden to patients with spinal cord injury (SCI), affecting their psychological, physical, and social well-being. Lifestyle choices are thought to contribute to the risk of developing PrUs. This article focuses on the interaction between lifestyle choices and the development of PrUs in community settings among participants in the University of Southern California-Rancho Los Amigos National Rehabilitation Center Pressure Ulcer Prevention Study (PUPS II), a randomized controlled trial of a lifestyle intervention for adults with SCI. We conducted a secondary cross-case analysis of treatment notes of 47 PUPS II participants and identified four patterns relating PrU development to lifestyle changes: positive PrU changes (e.g., healing PrUs) with positive lifestyle changes, negative or no PrU changes with positive lifestyle changes, positive PrU changes with minor lifestyle changes, and negative or no PrU changes with no lifestyle changes. We present case studies exemplifying each pattern.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

BACKGROUND: Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. PURPOSE: We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. METHODS: Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. RESULTS: PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. LIMITATIONS: We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. CONCLUSIONS: Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Development and validation of the activity significance personal evaluation (ASPEn) scale.

BACKGROUND/AIM: Engagement in desired occupations can promote health and wellbeing in older adults. Assessments of engagement often measure frequency, amount or importance of specific activities. This study aimed to develop a scale to measure older adults' evaluation of the extent to which their everyday activities are contributing to their health and wellness. METHODS: Eighteen items, each scored with a seven-point rating scale, were initially developed by content experts, covering perceptions of how daily activities contribute to physical and mental health, as well as satisfaction and activity participation in the last six months. Rasch analysis methods were used to refine the scale using the pencil and paper responses of 460 community-living older adults. RESULTS: Initial Rasch analysis indicated three unlabelled rating scale categories were seldom used, reducing measurement precision. Five items were conceptually different by misfit statistics and principal component analysis. Subsequently, those items were removed and the number of rating scale steps reduced to 4. The remaining 13-item, 4-step scale, termed the Activity Significance Personal Evaluation (ASPEn), formed a unidimensional hierarchy with good fit statistics and targeting. Person separation reliability (2.7) and internal consistency (.91) indicated the tool is appropriate for individual person measurement. Relative validity indicated equivalence between Rasch measures and total raw scores. CONCLUSIONS: ASPEn is a brief, easily administered assessment of older adults' perception of the contribution of everyday activities to personal health and wellness. ASPEn may facilitate occupational therapy practice by enabling clinicians to assess change in meaning of an older adult's activity over time.

Conducting intervention research among underserved populations: lessons learned and recommendations for researchers.

Randomized controlled trials (RCTs) are considered the criterion standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, because evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodologic article, we discuss the challenges and lessons learned in implementing the Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided.

Telehealth Lifestyle Redesign Occupational Therapy for Diabetes: Preliminary Effectiveness, Satisfaction, and Engagement.

Telehealth delivery of Lifestyle Redesign®, an occupational therapy intervention framework addressing health and quality of life among people with chronic conditions, is understudied. The objective of this study was to evaluate the effectiveness, satisfaction, and engagement of telehealth Lifestyle Redesign for young adults with diabetes. Using process data from two randomized controlled trials, we compared in-person and telehealth intervention effects. Among telehealth clients, effectiveness was assessed using pre-post changes in occupational performance, occupational satisfaction, and health management; a survey captured telehealth satisfaction. Attendance and engagement in in-person versus telehealth therapy were compared. Preliminary results indicate telehealth clients had significant increases in occupational performance, occupational satisfaction, and health management (all p < .02), and high levels of telehealth satisfaction. Intervention engagement (p = .59) and attendance (p = .42) were similar across treatment modalities. Telehealth delivery of Lifestyle Redesign occupational therapy is feasible and potentially efficacious, and continued advocacy is needed to ensure access to occupational therapy through telehealth.

Research design and baseline participant characteristics of the Resilient, Empowered, Active Living with Diabetes - Telehealth (REAL-T) Study: A randomized controlled trial for young adults with type 1 diabetes.

BACKGROUND: Type 1 diabetes (T1D) is a chronic condition affecting nearly 1.9 million people in the United States. Young adults (YAs) with T1D face unique challenges in managing their condition, experiencing poorer health and well-being than other age groups. The current study is evaluating the Resilient, Empowered, Active Living (REAL) intervention, previously shown to improve glucose levels and quality of life among YAs with diabetes, using telehealth delivery (REAL-T) to expand reach and accessibility. This paper reports on the methodology and baseline participant characteristics of the REAL-T study. METHODS: REAL-T is a two-arm randomized controlled trial that recruited 18-30 year olds with T1D via clinics and social media advertising. Data collection, which was adapted to be fully remote due to COVID-19, occurs every three months for one year. Participants receive either usual care or a 6-month telehealth occupational therapy intervention. The primary outcome is glycated hemoglobin (A1c); secondary outcomes include diabetes distress, quality of life, and continuous glucose monitor-derived measures. RESULTS: The study enrolled a diverse sample of 209 YAs with T1D. Analysis of baseline data indicates equivalence between the intervention and control groups. Study participants have notably higher diabetes distress and poorer mental well-being than similar populations. CONCLUSION: The REAL-T study successfully adapted to remote implementation during the COVID-19 pandemic. By examining long-term outcomes, mediating pathways, and cost-effectiveness, the study will contribute knowledge of the impact of tailored interventions for YAs with T1D, designed to reduce disparities and improve health and well-being in this population.

Preliminary User Evaluation of a Physical Activity Smartphone App for Older Adults.

Objectives: Mobile health (mHealth) delivered through smartphone apps is a viable means of improving health behaviors. Technologies can be strengthened and made more age-inclusive by involving older adults as co-designers, resulting in more accessible and effective products. This study's purpose is to describe preliminary acceptability and feasibility of a physical activity (PA) app tailored to underactive older people. Methods: Moving Up is a multi-feature app designed to increase PA and reduce sedentary behaviors in underactive older adults. The suite houses a core activity tracker and three add-on features that target correlates of inactivity: sedentary behavior, stereotypes about aging, and PA knowledge and routines. Three groups of 4-5 older adult smartphone owners were provided with and oriented to the Moving Up app activity tracker and one add-on feature. Participants beta-tested the app for two weeks, after which each cohort reconvened to discuss experiences, make recommendations for app improvements, and complete a usability questionnaire on their assigned feature. Results: Thirteen participants (median age, 71 years; iOS users, n=8; females, n=12) completed the beta-testing period and returned for follow-up. Reported usability was moderate across the features. Sentiments about app content and general impressions were mainly positive, although users made several recommendations for app improvements such as more individualized messaging and timely notifications. Conclusions: A PA app for older adults demonstrated generally good usability and acceptability. Integrating the impressions and recommendations from older adults into the design of mHealth tools will enhance overall usability and likelihood to positively influence PA behaviors long-term.

A qualitative analysis of pressure injury development among medically underserved adults with spinal cord injury.

Purpose: Medically underserved adults with spinal cord injury (SCI) remain at high risk of incurring medically serious pressure injuries even after receiving education in prevention techniques. The purpose of this research is to identify circumstances leading to medically serious pressure injury development in medically underserved adults with SCI during a lifestyle-based pressure injury prevention program, and provide recommendations for future rehabilitation approaches and intervention design.Methods: This study entailed a qualitative secondary case analysis of treatment notes from a randomized controlled trial. Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT.Results and conclusions: Among the 25 participants, 40 unique medically serious pressure injuries were detected. The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach. Together, these factors may have undermined the effectiveness of the intervention program. Modifications, such as assessing health literacy levels of patients prior to providing care, providing tailored wound care education, and focusing on equipment needs, have potential for altering future rehabilitation programs and improving health outcomes.Implications for rehabilitationTo provide patients with spinal cord injury with the necessary information to prevent medically serious pressure injury development, health care providers need to understand their patient's unique personal contexts, including socio-economic status, language skills, and mental/cognitive functioning.When providing wound care information to patients with spinal cord injury who have developed a medically serious pressure injury, practitioners should take into account the level of health literacy of their patient in order to provide education that is appropriate and understandable.Practitioners should be aware of how to help their patient advocate for outside services and care that address their equipment needs, such as finding funding or grants to pay for expensive medical equipment.

A Pilot Study of the ¡Vivir Mi Vida! Lifestyle Intervention for Rural-Dwelling, Late-Midlife Latinos: Study Design and Protocol.

Older, rural-dwelling Latinos face multiple health disparities. We describe the protocol of a pilot study of a community health worker-occupational therapist-led lifestyle program, ¡Vivir Mi Vida! ( ¡VMV!), designed for delivery in primary care and adapted for late-midlife, Latino rural-living patients. Using mixed methods, we collected feasibility, acceptability, and preliminary efficacy data on ¡VMV!. Forty 50- to 64-year-old Latinos participated in a 16-week lifestyle intervention led by a community health worker-occupational therapist team. We conducted pre- and post-intervention assessments to evaluate the efficacy of ¡VMV! in improving psychosocial and clinical health outcomes. Focus groups and interviews were held post-intervention with participants and key stakeholders to assess feasibility and acceptability. This is the first trial designed to evaluate a lifestyle intervention that includes collaboration between occupational therapists and community health workers within primary care. The detailed description of methodology promotes research transparency and reproducibility of a community health worker-occupational therapist-led lifestyle intervention.

Factors Protecting Against Pressure Injuries in Medically Underserved Adults With Spinal Cord Injury: A Qualitative Study.

Background: Pressure injuries negatively impact quality of life and participation for individuals with spinal cord injury (SCI). Objective: To examine the factors that may protect against the development of medically serious pressure injuries in adults with SCI. Methods: A qualitative analysis was conducted using treatment notes regarding 50 socioeconomically disadvantaged individuals who did not develop medically serious pressure injuries during a 12-month pressure injury prevention intervention program. Results: Eight types of potentially protective factors were identified: meaningful activity, motivation to prevent negative health outcomes, stability/resources, equipment, communication and self-advocacy skills, personal traits, physical factors, and behaviors/activities. Conclusions: Some protective factors (eg, personal traits) may be inherent to certain individuals and nonmodifiable. However, future interventions for this population may benefit from a focus on acquisition of medical equipment and facilitation of sustainable, health-promoting habits and routines. Substantive policy changes may be necessary to facilitate access to adequate resources, particularly housing and equipment, for socioeconomically disadvantaged individuals with SCI. Further research is needed to understand the complex interplay of risk and protective factors for pressure injuries in adults with SCI, particularly in underserved groups.

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

CONTEXT/OBJECTIVE: Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. DESIGN: A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. SETTING: Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. PARTICIPANTS: Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. INTERVENTIONS: The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. OUTCOME MEASURES: Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. RESULTS: Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. CONCLUSIONS: Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. TRIAL REGISTRATION: ClinicalTrials.gov NCT01999816.

Psychosocial and Behavioral Correlates of A1C and Quality of Life Among Young Adults With Diabetes.

PURPOSE: The purpose of this study was to evaluate relationships between behavioral and psychosocial constructs, A1C, and diabetes-dependent quality of life (DQoL) among low-socioeconomic status, ethnically diverse young adults with diabetes. METHODS: Using baseline data of 81 participants in the Resilient, Empowered, Active Living (REAL) randomized controlled trial, behavioral, cognitive, affective, and experiential variables were correlated with A1C and DQoL while adjusting for demographic characteristics, and these relationships were examined for potential effect modification. RESULTS: The data indicate that depressive symptoms and satisfaction with daily activities are associated with both A1C and DQoL, while diabetes knowledge and participation in daily activities are associated with neither A1C nor DQoL. Two constructs, diabetes distress and life satisfaction, were associated with DQoL and were unrelated to A1C, while 2 constructs, self-monitoring of blood glucose and medication adherence, were associated with A1C but unrelated to DQoL. These relationships were largely unchanged by adjusting for demographic characteristics, while numerous effect modifications were found. CONCLUSION: The data suggest that when tailoring interventions, depressive symptoms and satisfaction with daily activities may be particularly fruitful intervention targets, as they represent modifiable risk factors that are associated with both A1C and DQoL.

Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A1c [HbA1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests. RESULTS: Intent-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported. CONCLUSIONS: The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.