Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.

OBJECTIVES: Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population. MATERIALS AND METHODS: One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence. RESULTS: There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants. CONCLUSIONS: The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted. TRIAL REGISTRATION: NCT01550822.

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.

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.

Qualitative study of principles pertaining to lifestyle and pressure ulcer risk in adults with spinal cord injury.

PURPOSE: The aim of this article is to identify overarching principles that explain how daily lifestyle considerations affect pressure ulcer development as perceived by adults with spinal cord injury (SCI). METHOD: Qualitative in-depth interviews over an 18-month period with 20 adults with spinal injury and a history of pressure ulcers were conducted using narrative and thematic analyses. RESULTS: Eight complexly interrelated daily lifestyle principles that explain pressure ulcer development were identified: perpetual danger; change/disruption of routine; decay of prevention behaviors; lifestyle risk ratio; individualization; simultaneous presence of prevention awareness and motivation; lifestyle trade-off; and access to needed care, services and supports. CONCLUSIONS: Principles pertaining to the relationship between in-context lifestyle and pressure ulcer risk underscore previous quantitative findings, but also lead to new understandings of how risk unfolds in everyday life situations. Pressure ulcer prevention for community-dwelling adults with SCI can potentially be enhanced by incorporating principles, such as the decay of prevention behaviors or lifestyle trade-off, that highlight special patterns indicative of elevated risk. The identified principles can be used to theoretically drive future research or to guide innovative lifestyle-focused intervention approaches. Public policies that promote short-term preventive interventions at critical junctures throughout a person's life should be considered.

Decisions and Dilemmas in Everyday Life: Daily Use of Wheelchairs by Individuals with Spinal Cord Injury and the Impact on Pressure Ulcer Risk.

Individuals with spinal cord injury (SCI) use wheelchairs for mobility and for full participation in their daily activities. The use of wheelchairs, however, can increase the risk of pressure ulcers. This study focused on wheelchair users' perceptions of the interplay between their wheeled mobility and the development of pressure ulcers by performing a secondary analysis of data gathered during a 2-year ethnographic study of 20 community-dwelling adults with SCI. Data from a subset of these individuals are described; each of these stories contains a pressure ulcer risk episode related to wheeled mobility or cushion use. Identified risk episodes were associated with wheelchair selection, wheelchair adjustment, habituation to new equipment, lifestyle choices, and challenging life contexts. Examples highlighted the crucial relationship between individuals' minute-to-minute decision-making and pressure ulcer risk.

Mobile arm supports: evidence-based benefits and criteria for use.

BACKGROUND/OBJECTIVE: To collect data from therapists regarding criteria for use and activities that individuals with C4-C5 tetraplegia can perform using a mobile arm support (MAS) that they otherwise could not. Reasons for nonuse, equipment design limitations, and therapist training needs were also studied. METHODS: A modified Delphi approach was used to conduct an e-mail survey for which the response to each question was analyzed and used to formulate the subsequent question. SETTING: Rehabilitation centers. PARTICIPANTS: Eighteen occupational therapists (most affiliated with 1 of the federally designated Model Spinal Cord Injury Systems) with extensive experience in the treatment of individuals with spinal cord injury (SCI). RESULTS: The key physical prerequisite for successful use of the MAS was at least minimal strength of the deltoid and biceps muscles; 92% of respondents indicated that they would fit an MAS for motivated patients having very weak (<2/5) biceps and deltoid muscles. According to the therapists, 100% (n = 30) of their clients were able to perform at least 1 activity using a MAS that they were unable to perform without the device. These activities included (in descending frequency) eating, page turning, driving a power wheelchair, brushing teeth, keyboarding, writing, name signing, drawing, painting, scratching nose, playing board games, accessing electronic devices, drinking, and grooming. Equipment design limitations included increased wheelchair width and problems managing the arms while reclining. CONCLUSIONS: Mobile arm supports allow persons with C4-C5 tetraplegia to engage in activities that they otherwise cannot perform with their arms.

Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research.

BACKGROUND/OBJECTIVE: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome measures designed to assess functional status relevant to SCI are important to develop. METHOD: Evaluation of currently available SCI functional outcome measures by a multinational work group. RESULTS: The 4 measures that fit the prespecified inclusion criteria were the Modified Barthel Index (MBI), the Functional Independence Measure (FIM), the Quadriplegia Index of Function (QIF), and the Spinal Cord Independence Measure (SCIM). The MBI and the QIF were found to have minimal evidence for validity, whereas the FIM and the SCIM were found to be reliable and valid. The MBI has little clinical utility for use in the SCI population. Likewise, the FIM applies mainly when measuring burden of care, which is not necessarily a reflection of functional recovery. The QIF is useful for measuring functional recovery but only in a subpopulation of people with SCI, and substantial validity data are still required. The SCIM is the only functional recovery outcome measure designed specifically for SCI. CONCLUSIONS: The multinational work group recommends that the latest version of the SCIM (SCIM III) continue to be refined and validated and subsequently implemented worldwide as the primary functional recovery outcome measure for SCI. The QIF may continue to be developed and validated for use as a supplemental tool for the nonambulatory tetraplegic population.

Data-based models of how pressure ulcers develop in daily-living contexts of adults with spinal cord injury.

OBJECTIVE: To examine the daily-lifestyle influences on the development of pressure ulcers in adults with spinal cord injury (SCI). DESIGN: Qualitative investigation using in-depth interviewing and participant observation. SETTING: Participants were studied in their homes and other naturalistic contexts. PARTICIPANTS: Twenty men and women of diverse ethnicities with paraplegia or tetraplegia who were recruited at a pressure ulcer management clinic in a large rehabilitation facility. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Detailed descriptive information pertaining to the development of recurring pressure ulcers in relation to participants' daily routine and activity, personal choices, motivating influences, lifestyle challenges, and prevention techniques and strategies. RESULTS: The daily-lifestyle influences on pressure ulcer development in adults with SCI can be described through various models that vary in complexity, depending on whether they incorporate individualization, interrelations among modeled elements, situational specificity, and/or temporal comprehensiveness. Ulcers are most likely to develop when a person with a relatively high-risk background profile is exposed to an equilibrium-disrupting change event that culminates in a specific pressure ulcer risk episode. CONCLUSIONS: The results underscore the significant degree of complexity and individualization that characterize the emergence of pressure ulcers in daily-life contexts. Prevention efforts should therefore incorporate attention to the unique constellation of circumstances that comprise a person's everyday life.