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.

A Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Design of Healthy Eating and Lifestyle after Stroke (HEALS).

BACKGROUND: Stroke survivors have high rates of subsequent cardiovascular and recurrent cerebrovascular events, and mortality. While healthy lifestyle practices - including a diet rich in fruits and vegetables, limited alcohol intake, and regular physical activity - can mitigate these outcomes, few stroke survivors adhere to them. Minorities from socioeconomically disadvantaged communities who obtain care in safety-net health systems experience the most barriers to implementing healthy lifestyle changes after stroke. PURPOSE: To report the design of Healthy Eating and Lifestyle After Stroke (HEALS), a randomized controlled trial (RCT) was designed to test the feasibility of using a manualized, lifestyle management intervention in a safety-net setting to improve lifestyle practices among ethnically diverse individuals with stroke or transient ischemic attack (TIA). METHODS: Design: Pilot RCT. PARTICIPANTS: Inclusion criteria: 1) Adults (≥40 years) with ischemic stroke or TIA (≥ 90 days prior); 2) English- or Spanish-speaking. SETTING: Outpatient clinic, safety-net setting. INTERVENTION: Weekly two-hour small group sessions led by an occupational therapist for six weeks. The sessions focused on implementing nutrition, physical activity, and self-management strategies tailored to each participant's goals. MAIN OUTCOME MEASURES: Body mass index, diet, and physical activity. CONCLUSIONS: Recruitment for this study is complete. If the HEALS intervention study is feasible and effective, it will serve as a platform for a large-scale RCT that will investigate the efficacy and cost-effectiveness of life management interventions for racially and ethnically diverse, low-income individuals with a history of stroke or TIA who seek healthcare in the safety-net system.

Relationship between touch sensation of the affected hand and performance of valued activities in individuals with chronic stroke.

OBJECTIVE: To investigate the association between touch sensation of the affected hand and performance and satisfaction with performance of valued activities in individuals with chronic stroke. METHODS: Using a cross-sectional study design, this study correlated factors related to hand sensation and activity performance in individuals with chronic stroke. The Touch Test Evaluators and Canadian Occupational Performance Measure (COPM) were used. Correlations were used to determine the relationships between touch sensation of the affected hand and individuals' performance and satisfaction with performance of valued activities. RESULTS: There was a good to excellent relationship between sensation and performance and satisfaction with performance of valued activities for individuals with intact touch sensation of the affected hand who scored higher on the COPM. There was little to no relationship between touch sensation of the affected hand and performance of valued activities for individuals with impaired sensation. CONCLUSION: This is the first study to relate touch sensation of the affected hand and performance and satisfaction with performance of valued activities in individuals with stroke. The findings suggest that rehabilitation therapists need to continue to address sensory function in evaluation and intervention as it relates to performance in valued activities. This study serves as a foundation for future research in sensation and performance of valued activities in individuals with chronic stroke.

Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial.

Importance: Few stroke survivors meet recommended cardiovascular goals, particularly among racial/ethnic minority populations, such as Black or Hispanic individuals, or socioeconomically disadvantaged populations. Objective: To determine if a chronic care model-based, community health worker (CHW), advanced practice clinician (APC; including nurse practitioners or physician assistants), and physician team intervention improves risk factor control after stroke in a safety-net setting (ie, health care setting where all individuals receive care, regardless of health insurance status or ability to pay). Design, Setting, and Participants: This randomized clinical trial included participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial. Inclusion criteria were age 40 years or older; experience of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) no more than 90 days prior; systolic blood pressure (BP) of 130 mm Hg or greater or 120 to 130 mm Hg with history of hypertension or using hypertensive medications; and English or Spanish language proficiency. The exclusion criterion was inability to consent. Among 887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion. The study was conducted from February 2014 to September 2018, and data were analyzed from October 2018 to November 2020. Interventions: Participants randomized to intervention were offered a multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools. Participants randomized to the control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials. Main Outcomes and Measures: The primary outcome was change in systolic BP at 12 months. Secondary outcomes were non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months. Potential mediators assessed included access to care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use. Results: Among 487 participants included, the mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian. A total of 246 participants were randomized to usual care, and 241 participants were randomized to the intervention. Mean (SD) systolic BP improved from 143 (17) mm Hg at baseline to 133 (20) mm Hg at 12 months in the intervention group and from 146 (19) mm Hg at baseline to 137 (22) mm Hg at 12 months in the usual care group, with no significant differences in the change between groups. Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0]; P = .004) and serum CRP level (difference in log CRP, -0.4 [95% CI, -0.7 to -0.1] mg/dL; P = .003); there were no differences in other secondary outcomes. Although 216 participants (89.6%) in the intervention group received some of the 3 core components, only 35 participants (14.5%) received the intended full dose. Conclusions and Relevance: This randomized clinical trial of a complex multilevel, multimodal intervention did not find vascular risk factor improvements beyond that of usual care; however, further studies may consider testing the SUCCEED intervention with modifications to enhance implementation and participant engagement. Trial Registration: ClinicalTrials.gov Identifier: NCT01763203.

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.

A prospective, randomized, double-blind trial to evaluate the role of a short reducing course of oral corticosteroid therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome.

OBJECTIVES: To assess the validity of our observational experience that a short course of oral prednisolone therapy might be of value in the management of symptoms of chronic pelvic pain syndrome (CPPS) in men. PATIENTS AND METHODS: Twenty-one men with CPPS (inflammatory or non-inflammatory) for > or =6 months, and who had failed to improve with standard antibiotic therapy, were randomized to receive either a 1-month reducing course of oral prednisolone (nine) or an equivalent placebo regimen (12 men). The outcome measures used were the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale (HADS), General Health Questionnaire-30 (GHQ-30) and the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), which were completed at baseline and 3 months. RESULTS: Outcomes were analysed for the 18 patients (six treated, 12 placebo) who completed the 3 months of follow-up. At both baseline and 3 months, respectively, there was no statistically significant difference between the groups in the NIH-CPSI total score (P = 0.48 and 0.62; Mann-Whitney U-test), or in the HADS (anxiety, P = 0.85 and 0.67; depression P = 0.96 and 0.74), and there was no significant improvement or deterioration over time. Although not statistically significant, there was a trend to improvement in the depression score for the active group (P = 0.13). However, the clinical significance is doubtful, as both baseline and follow-up depression scores were within the normal range. No patient had clinically negative changes in depression. A 3-month follow-up analysis was not possible for the McGill Pain Questionnaire or GHQ-30 as not all patients completed the questionnaire. CONCLUSIONS: Whilst the study showed no clinical benefit of using corticosteroids in the management of CPPS, the few patients recruited limited the validity of firm conclusions from the data. There was a trend towards an improvement of depression levels amongst subjects. The study highlights the difficulties of recruitment and illustrates the complex psychological profiles of patients with CPPS.

The efficacy of splinting for lateral epicondylitis: a systematic review.

To determine the efficacy of using splinting as a treatment for lateral epicondylitis (LE), a systematic review of the literature was conducted on Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, PEDro, and Cochrane databases using pertinent key words and phrases. Hand searches of article references were also used to ensure that as many relevant articles as possible were identified. Searches were limited to articles published in English. Articles that did not involve splinting (or terminology derivative thereof) as treatment intervention for LE were excluded. From 98 potential articles, 58 were considered strong inclusion candidates. These articles were copied and further triaged according to predefined criteria, resulting in 22 articles that were numbered randomly and blinded. Three reviewers appraised these articles, eliminating 11 of the articles because they did not meet essential criteria of randomization, control group, and/or inferential statistical analysis. Using MacDermid quality scores, the 11 remaining articles were rated by three reviewers. Consensus between the three reviewers was achieved for all quality scores for all 11 articles included in the review. Adjusted quality scores ranged from 44.5 to 16.5 with a mean of 26.3 points. For accurate comparison and consistency of terminology, splints described in the included articles were first classified according to the ASHT Splint Classification, expanded and refined version, and next according to their inherent material properties. Six splints in five classification categories were identified. Discussion of the results from the 11 included studies was organized according to splint category and further separated into strength, pain, and load applied sections. This review identified one Sackett level 1b study and ten Sackett level 2b studies that offer early positive, but not conclusive, support for the effectiveness of splinting lateral epicondylitis. None of the reviewed studies received a perfect quality score, and the wide range of quality scores attests to the fact that considerable improvement of future studies is essential.