Physical activity self-management and coaching compared to social interaction in huntington disease: results from the ENGAGE-HD randomized, controlled, pilot feasibility trial.

Abstract Background: Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective: We assessed feasibility and outcomes of a 14 week physical activity self-management and coaching intervention compared with social contact in Huntington's disease (HD) to inform the design of a future full-scale trial. Design: Assessor blind, multi-site, randomized pilot feasibility trial. Setting: Participants were recruited and assessed at baseline, 16 weeks following randomisation, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention: People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements: Eligibility, recruitment, retention and intervention adherence were determined at 16 weeks. Other outcomes of interest included measures of functional, home and community mobility, self-efficacy, physical activity and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results: Forty % (n=46) of eligible patients were enrolled and 22 randomised to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92% respectively. Minimum adherence criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between group treatment effects on function, however increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lends support to our pre-defined intervention logic model. Limitations: The use of self-report measures may have introduced bias. Conclusions: An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation.Health and Care Research Wale

Development and Delivery of a Physical Activity Intervention for People With Huntington Disease:Facilitating Translation to Clinical Practice

Background and Purpose: We studied the development and delivery of a 14-week complex physical activity intervention for people with Huntington disease, where detailed information about the intervention was fully embedded in the trial design process. Methods: Intervention Development: The intervention was developed through a series of focus groups. The findings from the focus groups informed the development of a logic model for the physical activity intervention that was broadly consistent with the framework of self-determination theory. Intervention Delivery: Key components underpinning the delivery of the intervention were implemented including a defined coach training program and intervention fidelity assessment methods. Training of coaches (physical therapists, occupational therapists, research nurses, and exercise trainers) was delivered via group and 1:1 training sessions using a detailed coach's manual, and with ongoing support via video calls, and e-mail communication as needed. Detailed documentation was provided to determine costs of intervention development and coach training. Results: Intervention delivery coaches at 8 sites across the United Kingdom participated in the face-to-face training. Self-report checklists completed by each of the coaches indicated that all components of the intervention were delivered in accordance with the protocol. Mean (standard deviation) intervention fidelity scores (n = 15), as measured using a purpose-developed rating scale, was 11 (2.4) (out of 16 possible points). Coaches' perceptions of intervention fidelity were similarly high. The total cost of developing the intervention and providing training was [pounds]30,773 ($47,042 USD). Discussion and Conclusions: An important consideration in promoting translation of clinical research into practice is the ability to convey the detailed components of how the intervention was delivered to facilitate replication if the results are favorable. This report presents an illustrative example of a physical activity intervention, including the development and the training required to deliver it. This approach has the potential to facilitate reproducibility, evidence synthesis, and implementation in clinical practice

Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study

Background Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide.Methods A multimethods analysis was performed as part of the GlobalSurg 3 study-a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital.Findings Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3.85 [95% CI 2.58-5.75]; p<0.0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63.0% vs 82.7%; OR 0.35 [0.23-0.53]; p<0.0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer.Interpretation Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised

L'Avenir financier des femmes : comment envisager la retraite au mitan de la vie? /

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Integrating technology into complex intervention trial processes: a case study

Background Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. Results The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. Conclusions A combination of commercially available hardware and a bespoke online database designed to support data collection, intervention fidelity and trial progress provides a viable option for streamlining trial processes in a multicentre complex intervention trial. There is scope to further extend the system to cater for larger trials and add further functionality such as automatic reporting facilities and participant management support

M11 A randomised controlled feasibility trial of a physical activity behaviour change intervention compared to social interaction in huntington’s disease.

Background Regular physical activity has health benefits for people with Huntington’s disease (HD), however consistent engagement is challenging. We report the results of a single blind, multi-site, randomised controlled feasibility trial of a physical activity intervention in HD. Methods Participants were randomly assigned to physical activity or social contact control interventions. The primary outcome was feasibility. Short-term benefit was assessed with the Physical Performance Test (PPT), a measure of functional ability. A range of exploratory outcomes including home and community mobility (Life Space), self-efficacy (Lorig), physical activity (International Physical Activity Questionnaire (IPAQ)), as well as disease-specific measures of motor and cognitive function were evaluated. Intervention fidelity and delivery costs were established. The trial was registered (ISRCTN 65378754 (13/03/2014)). Results We recruited 46 people with HD; 22 were randomised to the physical intervention (n = 16 analysed); 24 to social contact (n = 22 analysed). Retention, fidelity and adherence met pre-determined criteria. IPAQ scores in the physical intervention group were 142% higher (1.42; 95% CI: [−22%%, 653%]); and self-efficacy for exercise (1.6; 95% CI: [0.6, 2.7]) was also higher. Life Space scores were 12 points different between groups; 95% CI: [−2, 27]. Cognitive function was better in the physical intervention group with 2·9 more correct responses (95% CI: [0.01, 5.9]) on the Symbol Digit Modality test. There were no differences in other exploratory outcome measures and in particular no between-group differences in the PPT (treatment effect: 0.3, 95% CI: [−2.1, 2.7]). Mean (SD) physical intervention per session cost was £56.97 (£34.72). Conclusion A physical activity coaching intervention is feasible, can improve self-efficacy, physical activity behaviours and cognitive function in people with HD and represents excellent value for money in a devastating disease.Health and Care Research Wales