Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial.

BACKGROUND: Chronic low back pain is prevalent and disabling in Veterans, but effective pain management is challenging. Clinical practice guidelines emphasize multimodal pain management including evidence-based complementary and integrative health treatments such as acupressure as a first line of care. Unfortunately, the ability to replicate interventions, cost, resources, and limited access are implementation barriers. Self-administered acupressure has shown positive effects on pain and can be practiced anywhere with little to no side effects. METHODS/DESIGN: The aims of this Type 1 hybrid effectiveness implementation randomized controlled trial are 1) to determine effectiveness of a self-administered acupressure protocol at improving pain interference and secondary outcomes of fatigue, sleep quality, and disability in 300 Veterans with chronic low back pain, and 2) evaluate implementation barriers and facilitators to scale-up acupressure utilization within Veterans Health Administration (VHA). Participants randomized to the intervention will receive instruction on acupressure application using an app that facilitates daily practice for 6 weeks. During weeks 6 through 10, participants will discontinue acupressure to determine sustainability of effects. Participants randomized to waitlist control will continue their usual care for pain management and receive study materials at the end of the study period. Outcomes will be collected at baseline and at 6- and 10-weeks post baseline. The primary outcome is pain interference, measured by the PROMIS pain interference scale. Using established frameworks and a mixed methods approach, we will evaluate intervention implementation. DISCUSSION: If acupressure is effective, we will tailor strategies to support implementation in the VHA based on study findings. TRIAL REGISTRATION NUMBER: NCT05423145.

Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.

BACKGROUND: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. OBJECTIVE: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. METHODS: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George's Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. RESULTS: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants' goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months. CONCLUSIONS: An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA. CLINICALTRIAL: Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC).

Sex Differences in Weight Loss among Veterans with Serious Mental Illness: Observational Study of a National Weight Management Program.

PURPOSE: Obesity disproportionately burdens individuals with serious mental illness (SMI), especially women. This observational study investigated whether there were sex differences in weight loss and program participation among veterans with SMI enrolled in the Veterans Health Administration's (VHA) MOVE! weight management program. PROCEDURES: Participants were identified from a national cohort of 148,254 veterans enrolled in MOVE! during fiscal years 2008 through 2012 who attended two or more sessions within 12 months of enrollment. The cohort included those with International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnoses for SMI, age less than 70 years, and weight data at baseline and one or more follow-up timepoints within approximately 1 year of enrollment (n = 8,943 men; n = 2,245 women). Linear mixed models assessed associations of sex with 6- and 12-month weight change from baseline, adjusting for demographic- and site-level variables. FINDINGS: Both sexes averaged 6.4 (standard deviation, 4.6) sessions within 12 months; however, women with and without SMI participated at rates double their respective proportion rates among all VHA users. Participants averaged statistically significant weight loss at 6 months (men, -2.5 lb [95% CI, -2.8 to -2.1]; women, -2.4 lb [95% CI, -3.1 to -1.7]) and 12 months (men, -2.5 lb [95% CI, -2.8 to -2.2]; women, -2.9 lb [95% CI, -3.6 to -2.2]), but no sex-based difference in absolute weight loss at either timepoint. Slightly more women achieved 5% or greater (clinically significant) weight loss at the 12-month follow-up than did men (25.7% vs. 23.0%; p < .05). CONCLUSIONS: Women with SMI participated in MOVE! at rates equivalent to or greater than men with SMI, with comparable weight loss. More women were Black, single, had bipolar and posttraumatic stress disorder, and higher service-connected disability, suggesting areas for program customization.

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial.

BACKGROUND: Low levels of physical activity (PA) are associated with poor outcomes in people with COPD. Interventions to increase PA could improve outcomes. METHODS: We tested the efficacy of a novel Internet-mediated, pedometer-based exercise intervention. Veterans with COPD (N = 239) were randomized in a 2:1 ratio to the (1) intervention group (Omron HJ-720 ITC pedometer and Internet-mediated program) or (2) wait-list control group (pedometer). The primary outcome was health-related quality of life (HRQL), assessed by the St. George's Respiratory Questionnaire (SGRQ), at 4 months. We examined the SGRQ total score (SGRQ-TS) and three domain scores: Symptoms, Activities, and Impact. The secondary outcome was daily step counts. Linear regression models assessed the effect of intervention on outcomes. RESULTS: Participants had a mean age of 67 ± 9 years, and 94% were men. There was no significant between-group difference in mean 4-month SGRQ-TS (2.3 units, P = .14). Nevertheless, a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS, the minimum clinically important difference (53% vs 39%, respectively, P = .05). For domain scores, the intervention group had a lower (reflecting better HRQL) mean than the control group by 4.6 units for Symptoms (P = .046) and by 3.3 units for Impact (P = .049). There was no significant difference in Activities score between the two groups. Compared with the control subjects, intervention participants walked 779 more steps per day at 4 months (P = .005). CONCLUSIONS: An Internet-mediated, pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD. TRIAL REGISTRY: Clinical Trials.gov; No.: NCT01102777; URL: www.clinicaltrials.gov.

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease.

BACKGROUND: Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. METHODS/DESIGN: This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. DISCUSSION: Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George's Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220).Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. TRIAL REGISTRATION: Clinical Trials.gov NCT01102777.