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Methodological challenges of multiple-component intervention: lessons learned from a randomized controlled trial of functional recovery after hip fracture.

ABSTRACT: We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery after hip fracture. One hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90). Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months. At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment. Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape. Intervention patients experienced a significant (P = 0.03) improvement in the role-physical domain (mean change, -11 +/- 33) compared to control patients (mean change, -37 +/- 41). Change in general health (P = 0.2) and mental health (P = 0.1) domain scores was also directionally consistent with the study hypothesis. Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up. We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community.

SUBMITTER: Allegrante JP

PROVIDER: S-EPMC2504100 | biostudies-other | 2007 Feb

REPOSITORIES: biostudies-other

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Project description:BACKGROUND:Historical changes in the nature of sedentary activities have been observed in other countries, but it is not clear if similar trends exist in Canada. It is also unclear how changes in the measurement of sedentary behaviour affects national estimates. Our objective is to document all sources and measures of sedentary behaviour from Canadian, nationally representative surveys, and report on selected estimates of time spent in sedentary activities. Lessons learned can benefit the wider international surveillance community. METHODS:We describe and document all data sources of sedentary behaviour at the national level in Canada, and report on selected prevalence data from repeated cross-sectional surveys. We summarize amounts of total device-assessed sedentary time and self-reported sedentary activities (e.g., passive travel, leisure television, computer, video games, screen, and reading) by age group over time. RESULTS:Nineteen national surveys were identified. Changes in questions and/or response categories precluded direct assessment of trends over time for some measures; however, certain trends were observed. Accelerometer-measured sedentary time, leisure reading (among those <?50?years) and television/video viewing in younger age groups have remained relatively stable (with a possible slight decline in television/video viewing). Time spent in passive travel and leisure computer and electronic device use appears to have increased. Television and video viewing appears to have increased in older adults while their leisure reading appears to have fallen. CONCLUSIONS:Changes in measurement of sedentary behaviour can affect estimates and reduce comparability over time. Total leisure screen use appears to have increased over time, reflecting the ways in which Canadians spend their free time and technological advances. The main public health message is the need for continued efforts to reduce leisure screen use, especially among youth and older adults.

Project description:BackgroundSmoking rates are significantly higher among young people experiencing homelessness than in the general population. Despite a willingness to quit, homeless youth have little success in doing so on their own, and existing cessation resources tailored to this population are lacking. Homeless youth generally enjoy the camaraderie and peer support that group-based programs offer, but continuous in-person support during a quit attempt can be prohibitively expensive.ObjectiveThis study aimed to assess the feasibility and acceptability of an automated text messaging intervention (TMI) as an adjunct to group-based cessation counseling and provision of nicotine patches to help homeless youth quit smoking. This paper outlines the lessons learned from the implementation of the TMI intervention.MethodsHomeless youth smokers aged 18 to 25 years who were interested in quitting (n=77) were recruited from drop-in centers serving homeless youth in the Los Angeles area. In this pilot randomized controlled trial, all participants received a group-based cessation counseling session and nicotine patches, with 52% (40/77) randomly assigned to receive 6 weeks of text messages to provide additional support for their quit attempt. Participants received text messages on their own phone rather than receiving a study-issued phone for the TMI. We analyzed baseline and follow-up survey data as well as back-end data from the messaging platform to gauge the acceptability and feasibility of the TMI among the 40 participants who received it.ResultsParticipants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages. Participants experienced interruptions in their phone use (eg, 44% [16/36] changed phone numbers during the follow-up period) but reported being able to receive the majority of messages. These survey results were corroborated by back-end data (from the program used to administer the TMI) showing a message delivery rate of about 95%. Participant feedback points to the importance of carefully crafting text messages, which led to high (typically above 70%) approval of most text messaging components of the intervention. Qualitative feedback indicated that participants enjoyed the group counseling session that preceded the TMI and suggested including more such group elements into the intervention.ConclusionsThe TMI was well accepted and feasible to support smoking cessation among homeless youth. Given high rates of smartphone ownership, the next generation of phone-based smoking cessation interventions for this population should consider using approaches beyond text messages and focus on finding ways to develop effective approaches to include group interaction using remote implementation. Given overall resource constraints and in particular the exigencies of the currently ongoing COVID-19 epidemic, phone-based interventions are a promising approach to support homeless youth, a population urgently in need of effective smoking cessation interventions.Trial registrationClinicalTrials.gov NCT03874585; https://clinicaltrials.gov/ct2/show/NCT03874585.International registered report identifier (irrid)RR2-10.1186/s13722-020-00187-6.

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Project description:BackgroundCancer Care Delivery (CCD) research studies often require practice-level interventions that pose challenges in the clinical trial setting. The SWOG Cancer Research Network (SWOG) conducted S1415CD, one of the first pragmatic cluster-randomized CCD trials to be implemented through the National Cancer Institute (NCI) Community Oncology Program (NCORP), to compare outcomes of primary prophylactic colony stimulating factor (PP-CSF) use for an intervention of automated PP-CSF standing orders to usual care. The introduction of new methods for study implementation created challenges and opportunities for learning that can inform the design and approach of future CCD interventions.MethodsThe order entry system intervention was administered at the site level; sites were affiliated NCORP practices that shared the same chemotherapy order system. 32 sites without existing guideline-based PP-CSF standing orders were randomized to the intervention (n = 24) or to usual care (n = 8). Sites assigned to the intervention participated in tailored training, phone calls and onboarding activities administered by research team staff and were provided with additional funding and external IT support to help them make protocol required changes to their order entry systems.ResultsThe average length of time for intervention sites to complete reconfiguration of their order sets following randomization was 7.2 months. 14 of 24 of intervention sites met their individual patient recruitment target of 99 patients enrolled per site.ConclusionsIn this paper we share seven recommendations based on lessons learned from implementation of the S1415CD intervention at NCORP community oncology practices representing diverse geographies and patient populations across the U. S. It is our hope these recommendations can be used to guide future implementation of CCD interventions in both research and community settings.Trial registrationNCT02728596 , registered April 5, 2016.

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Methodological challenges of multiple-component intervention: lessons learned from a randomized controlled trial of functional recovery after hip fracture.

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