173 resultados para Randomised control trial
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Introduction: Schools provide the opportunity to reach a large number of adolescents in a systematic way however there are increasing demands on curriculum providing challenges for health promotion activities. This paper will describe the research processes and strategies used to design an injury prevention program.----- Methods: A multi-stage process of data collection included: (1) Surveys on injury-risk behaviours to identify targets of change (examining behaviour and risk/ protective factors among more than 4000 adolescents); (2) Focus groups (n= 30 high-risk adolescents) to understand and determine risk situations; (3) Hospital emergency outpatients survey to understand injury types/ situations; (4) Workshop (n= 50 teachers/ administrators) to understand the target curriculum and experiences with injury-risk behaviours; (5) Additional focus groups (students and teachers) regarding draft material and processes.----- Results: Summaries of findings from each stage are presented particularly demonstrating the design process. The baseline data identified target risk and protective factors. The following qualitative study provided detail about content and context and with the hospital findings assisted in developing ways to ensure relevance and meaning (e.g. identifying high risk situations and providing insights into language, culture and development). School staff identified links to school processes with final data providing feedback on curriculum fit, feasibility and appropriateness of resources. The data were integrated into a program which demonstrated reduced injury.----- Conclusions: A comprehensive research process is required to develop an informed and effective intervention. The next stage of a cluster randomised control trial is a major task and justifies the intensive and comprehensive development.
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Objective: The aim of this literature review is to identify the role of probiotics in the management of enteral tube feeding (ETF) diarrhoea in critically ill patients.---------- Background: Diarrhoea is a common gastrointestinal problem seen in ETF patients. The incidence of diarrhoea in tube fed patients varies from 2% to 68% across all patients. Despite extensive investigation, the pathogenesis surrounding ETF diarrhoea remains unclear. Evidence to support probiotics to manage ETF diarrhoea in critically ill patients remains sparse.---------- Method: Literature on ETF diarrhoea and probiotics in critically ill, adult patients was reviewed from 1980 to 2010. The Cochrane Library, Pubmed, Science Direct, Medline and the Cumulative Index of Nursing and Allied Health Literature (CINAHL) electronic databases were searched using specific inclusion/exclusion criteria. Key search terms used were: enteral nutrition, diarrhoea, critical illness, probiotics, probiotic species and randomised clinical control trial (RCT).---------- Results: Four RCT papers were identified with two reporting full studies, one reporting a pilot RCT and one conference abstract reporting an RCT pilot study. A trend towards a reduction in diarrhoea incidence was observed in the probiotic groups. However, mortality associated with probiotic use in some severely and critically ill patients must caution the clinician against its use.---------- Conclusion: Evidence to support probiotic use in the management of ETF diarrhoea in critically ill patients remains unclear. This paper argues that probiotics should not be administered to critically ill patients until further research has been conducted to examine the causal relationship between probiotics and mortality, irrespective of the patient's disease state or projected prophylactic benefit of probiotic administration.
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Purpose To explore the perspectives of cancer care centre users on participation in psychosocial research to inform research design and ethics. Methods The study is based on a qualitative research design. Fourteen semistructured interviews were carried in people diagnosed with cancer and carers. The interview included four main questions about practical barriers to participation, types of research design, motivating factors and the conduct of research in a cancer care support setting. The data were analysed using qualitative content analysis. Results Interviewees demonstrated a willingness to participate in psychosocial research within certain circumstances. There were no practical barriers identified, although they considered payment for research-related travel important. The most acceptable research design was the face-to-face interview and the least preferred was the randomised control trial. The factors that motivated participation were altruism, valuing research, and making a contribution to the centre. Interviewees supported the conduct of research in cancer care support centres conditional upon delaying recruitment during the initial months of users’ visits and its need to be discreet to avoid deterring visitors from accessing the centre. Conclusions The study concludes that the personal interaction between participants and researchers is the most important feature of decision-making by patients/carers to join studies. Taking into account the perspectives of people affected by cancer during the early stages of research design may enhance recruitment and retention and can contribute to the development of research protocols and ethics.
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Alterations in cognitive function are characteristic of the aging process in humans and other animals. However, the nature of these age related changes in cognition is complex and is likely to be influenced by interactions between genetic predispositions and environmental factors resulting in dynamic fluctuations within and between individuals. These inter and intra-individual fluctuations are evident in both so-called normal cognitive aging and at the onset of cognitive pathology. Mild Cognitive Impairment (MCI), thought to be a prodromal phase of dementia, represents perhaps the final opportunity to mitigate cognitive declines that may lead to terminal conditions such as dementia. The prognosis for people with MCI is mixed with the evidence suggesting that many will remain stable within 10-years of diagnosis, many will improve, and many will transition to dementia. If the characteristics of people who do not progress to dementia from MCI can be identified and replicated in others it may be possible to reduce or delay dementia onset, thus reducing a growing personal and public health burden. Furthermore, if MCI onset can be prevented or delayed, the burden of cognitive decline in aging populations worldwide may be reduced. A cognitive domain that is sensitive to the effects of advancing age, and declines in which have been shown to presage the onset of dementia in MCI patients, is executive function. Moreover, environmental factors such as diet and physical activity have been shown to affect performance on tests of executive function. For example, improvements in executive function have been demonstrated as a result of increased aerobic and anaerobic physical activity and, although the evidence is not as strong, findings from dietary interventions suggest certain nutrients may preserve or improve executive functions in old age. These encouraging findings have been demonstrated in older adults with MCI and their non-impaired peers. However, there are some gaps in the literature that need to be addressed. For example, little is known about the effect on cognition of an interaction between diet and physical activity. Both are important contributors to health and wellbeing, and a growing body of evidence attests to their importance in mental and cognitive health in aging individuals. Yet physical activity and diet are rarely considered together in the context of cognitive function. There is also little known about potential underlying biological mechanisms that might explain the physical activity/diet/cognition relationship. The first aim of this program of research was to examine the individual and interactive role of physical activity and diet, specifically long chain polyunsaturated fatty acid consumption(LCn3) as predictors of MCI status. The second aim is to examine executive function in MCI in the context of the individual and interactive effects of physical activity and LCn3.. A third aim was to explore the role of immune and endocrine system biomarkers as possible mediators in the relationship between LCn3, physical activity and cognition. Study 1a was a cross-sectional analysis of MCI status as a function of erythrocyte proportions of an interaction between physical activity and LCn3. The marine based LCn3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have both received support in the literature as having cognitive benefits, although comparisons of the relative benefits of EPA or DHA, particularly in relation to the aetiology of MCI, are rare. Furthermore, a limited amount of research has examined the cognitive benefits of physical activity in terms of MCI onset. No studies have examined the potential interactive benefits of physical activity and either EPA or DHA. Eighty-four male and female adults aged 65 to 87 years, 50 with MCI and 34 without, participated in Study 1a. A logistic binary regression was conducted with MCI status as a dependent variable, and the individual and interactive relationships between physical activity and either EPA or DHA as predictors. Physical activity was measured using a questionnaire and specific physical activity categories were weighted according to the metabolic equivalents (METs) of each activity to create a physical activity intensity index (PAI). A significant relationship was identified between MCI outcome and the interaction between the PAI and EPA; participants with a higher PAI and higher erythrocyte proportions of EPA were more likely to be classified as non-MCI than their less active peers with less EPA. Study 1b was a randomised control trial using the participants from Study 1a who were identified with MCI. Given the importance of executive function as a determinant of progression to more severe forms of cognitive impairment and dementia, Study 1b aimed to examine the individual and interactive effect of physical activity and supplementation with either EPA or DHA on executive function in a sample of older adults with MCI. Fifty male and female participants were randomly allocated to supplementation groups to receive 6-months of supplementation with EPA, or DHA, or linoleic acid (LA), a long chain polyunsaturated omega-6 fatty acid not known for its cognitive enhancing properties. Physical activity was measured using the PAI from Study 1a at baseline and follow-up. Executive function was measured using five tests thought to measure different executive function domains. Erythrocyte proportions of EPA and DHA were higher at follow-up; however, PAI was not significantly different. There was also a significant improvement in three of the five executive function tests at follow-up. However, regression analyses revealed that none of the variance in executive function at follow-up was predicted by EPA, DHA, PAI, the EPA by PAI interaction, or the DHA by PAI interaction. The absence of an effect may be due to a small sample resulting in limited power to find an effect, the lack of change in physical activity over time in terms of volume and/or intensity, or a combination of both reduced power and no change in physical activity. Study 2a was a cross-sectional study using cognitively unimpaired older adults to examine the individual and interactive effects of LCn3 and PAI on executive function. Several possible explanations for the absence of an effect were identified. From this consideration of alternative explanations it was hypothesised that post-onset interventions with LCn3 either alone or in interation with self-reported physical activity may not be beneficial in MCI. Thus executive function responses to the individual and interactive effects of physical activity and LCn3 were examined in a sample of older male and female adults without cognitive impairment (n = 50). A further aim of study 2a was to operationalise executive function using principal components analysis (PCA) of several executive function tests. This approach was used firstly as a data reduction technique to overcome the task impurity problem, and secondly to examine the executive function structure of the sample for evidence of de-differentiation. Two executive function components were identified as a result of the PCA (EF 1 and EF 2). However, EPA, DHA, the PAI, or the EPA by PAI or DHA by PAI interactions did not account for any variance in the executive function components in subsequent hierarchical multiple regressions. Study 2b was an exploratory correlational study designed to explore the possibility that immune and endocrine system biomarkers may act as mediators of the relationship between LCn3, PAI, the interaction between LCn3 and PAI, and executive functions. Insulin-like growth factor-1 (IGF-1), an endocrine system growth hormone, and interleukin-6 (IL-6) an immune system cytokine involved in the acute inflammatory response, have both been shown to affect cognition including executive functions. Moreover, IGF-1 and IL-6 have been shown to be antithetical in so far as chronically increased IL-6 has been associated with reduced IGF-1 levels, a relationship that has been linked to age related morbidity. Further, physical activity and LCn3 have been shown to modulate levels of both IGF-1 and IL-6. Thus, it is possible that the cognitive enhancing effects of LCn3, physical activity or their interaction are mediated by changes in the balance between IL-6 and IGF-1. Partial and non-parametric correlations were conducted in a subsample of participants from Study 2a (n = 13) to explore these relationships. Correlations of interest did not reach significance; however, the coefficients were quite large for several relationships suggesting studies with larger samples may be warranted. In summary, the current program of research found some evidence supporting an interaction between EPA, not DHA, and higher energy expenditure via physical activity in differentiating between older adults with and without MCI. However, a RCT examining executive function in older adults with MCI found no support for increasing EPA or DHA while maintaining current levels of energy expenditure. Furthermore, a cross-sectional study examining executive function in older adults without MCI found no support for better executive function performance as a function of increased EPA or DHA consumption, greater energy expenditure via physical activity or an interaction between physical activity and either EPA or DHA. Finally, an examination of endocrine and immune system biomarkers revealed promising relationships in terms of executive function in non-MCI older adults particularly with respect to LCn3 and physical activity. Taken together, these findings demonstrate a potential benefit of increasing physical activity and LCn3 consumption, particularly EPA, in mitigating the risk of developing MCI. In contrast, no support was found for a benefit to executive function as a result of increased physical activity, LCn3 consumption or an interaction between physical activity and LCn3, in participants with and without MCI. These results are discussed with reference to previous findings in the literature including possible limitations and opportunities for future research.
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Background and significance: Nurses' job dissatisfaction is associated with negative nursing and patient outcomes. One of the most powerful reasons for nurses to stay in an organisation is satisfaction with leadership. However, nurses are frequently promoted to leadership positions without appropriate preparation for the role. Although a number of leadership programs have been described, none have been tested for effectiveness, using a randomised control trial methodology. Aims: The aims of this research were to develop an evidence based leadership program and to test its effectiveness on nurse unit managers' (NUMs') and nursing staff's (NS's) job satisfaction, and on the leader behaviour scores of nurse unit managers. Methods: First, the study used a comprehensive literature review to examine the evidence on job satisfaction, leadership and front-line manager competencies. From this evidence a summary of leadership practices was developed to construct a two component leadership model. The components of this model were then combined with the evidence distilled from previous leadership development programs to develop a Leadership Development Program (LDP). This evidence integrated the program's design, its contents, teaching strategies and learning environment. Central to the LDP were the evidence-based leadership practices associated with increasing nurses' job satisfaction. A randomised controlled trial (RCT) design was employed for this research to test the effectiveness of the LDP. A RCT is one of the most powerful tools of research and the use of this method makes this study unique, as a RCT has never been used previously to evaluate any leadership program for front-line nurse managers. Thirty-nine consenting nurse unit managers from a large tertiary hospital were randomly allocated to receive either the leadership program or only the program's written information about leadership. Demographic baseline data were collected from participants in the NUM groups and the nursing staff who reported to them. Validated questionnaires measuring job satisfaction and leader behaviours were administered at baseline, at three months after the commencement of the intervention and at six months after the commencement of the intervention, to the nurse unit managers and to the NS. Independent and paired t-tests were used to analyse continuous outcome variables and Chi Square tests were used for categorical data. Results: The study found that the nurse unit managers' overall job satisfaction score was higher at 3-months (p = 0.016) and at 6-months p = 0.027) post commencement of the intervention in the intervention group compared with the control group. Similarly, at 3-months testing, mean scores in the intervention group were higher in five of the six "positive" sub-categories of the leader behaviour scale when compared to the control group. There was a significant difference in one sub-category; effectiveness, p = 0.015. No differences were observed in leadership behaviour scores between groups by 6-months post commencement of the intervention. Over time, at three month and six month testing there were significant increases in four transformational leader behaviour scores and in one positive transactional leader behaviour scores in the intervention group. Over time at 3-month testing, there were significant increases in the three leader behaviour outcome scores, however at 6-months testing; only one of these leader behaviour outcome scores remained significantly increased. Job satisfaction scores were not significantly increased between the NS groups at three months and at six months post commencement of the intervention. However, over time within the intervention group at 6-month testing there was a significant increase in job satisfaction scores of NS. There were no significant increases in NUM leader behaviour scores in the intervention group, as rated by the nursing staff who reported to them. Over time, at 3-month testing, NS rated nurse unit managers' leader behaviour scores significantly lower in two leader behaviours and two leader behaviour outcome scores. At 6-month testing, over time, one leader behaviour score was rated significantly lower and the nontransactional leader behaviour was rated significantly higher. Discussion: The study represents the first attempt to test the effectiveness of a leadership development program (LDP) for nurse unit managers using a RCT. The program's design, contents, teaching strategies and learning environment were based on a summary of the literature. The overall improvement in role satisfaction was sustained for at least 6-months post intervention. The study's results may reflect the program's evidence-based approach to developing the LDP, which increased the nurse unit managers' confidence in their role and thereby their job satisfaction. Two other factors possibly contributed to nurse unit managers' increased job satisfaction scores. These are: the program's teaching strategies, which included the involvement of the executive nursing team of the hospital, and the fact that the LDP provided recognition of the importance of the NUM role within the hospital. Consequently, participating in the program may have led to nurse unit managers feeling valued and rewarded for their service; hence more satisfied. Leadership behaviours remaining unchanged between groups at the 6 months data collection time may relate to the LDP needing to be conducted for a longer time period. This is suggested because within the intervention group, over time, at 3 and 6 months there were significant increases in self-reported leader behaviours. The lack of significant changes in leader behaviour scores between groups may equally signify that leader behaviours require different interventions to achieve change. Nursing staff results suggest that the LDP's design needs to consider involving NS in the program's aims and progress from the outset. It is also possible that by including regular feedback from NS to the nurse unit managers during the LDP that NS's job satisfaction and their perception of nurse unit managers' leader behaviours may alter. Conclusion/Implications: This study highlights the value of providing an evidence-based leadership program to nurse unit managers to increase their job satisfaction. The evidence based leadership program increased job satisfaction but its effect on leadership behaviour was only seen over time. Further research is required to test interventions which attempt to change leader behaviours. Also further research on NS' job satisfaction is required to test the indirect effects of LDP on NS whose nurse unit managers participate in LDPs.
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This thesis was concerned with the protective mechanisms of first aid training in the context of peer support. Using a randomised control trial design the current program of research explores first aid training in the school setting and identifies the key components of effective school-based first aid training programs. In particular, examining whether first aid training and associated knowledge could be protective for early adolescents. This broader framing considered whether first aid impacted on increasing behaviour and attitudes towards helping an injured friend, and reducing personal risk taking and related injury.
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This report describes the Year One Pilot Study processes, and articulates findings from the major project components designed to address these challenges noted above (See Figure 1). Specifically, the pilot study tested the campaign research and development process involving participatory design with young people and sector partners, and the efficacy and practicality of conducting a longitudinal, randomised control trial online with minors, including ways oflinking survey data to campaign data. Each sub-study comprehensively considered the ethical requirements of conducting online research with minors in school settings. The theoretical and methodological framework for measuring campaign engagement and efficacy (Sub-studies 3, 4 and 5) drew on the Model of Goal-Directed Behaviour (MGB) (Perugini & Bagozzi 2001) and Nudge Theory (Thaler & Sunstein, 2008).
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Observational studies have shown that medical and dental students have poor psychological health worldwide; however, few interventional studies have been used to test approaches to help students. This thesis used a randomised control trial study design to evaluate the effect of a self-development coaching program on psychological health and the academic performance among medical and dental students in Saudi Arabia. The outcomes indicated that these medical and dental students in Saudi Arabia experienced high levels of depression, anxiety and stress, and that the self-development coaching program was a promising intervention to improve students' psychological health.
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Objectives This randomised, controlled trial compared the effectiveness of 0.12% chlorhexidine (CHX) gel and 304% fluoride toothpaste to prevent early childhood caries (ECC) in a birth cohort by 24 months. Methods The participants were randomised to receive either (i) twice daily toothbrushing with toothpaste and once daily 0.12% CHX gel (n = 110) or (ii) twice daily toothbrushing with toothpaste only (study controls) (n = 89). The primary outcome measured was caries incidence and the secondary outcome was percentage of children with mutans streptococci (MS). All mothers were contacted by telephone at 6, 12, and 18 months. At 24 months, all children were examined at a community dental clinic. Results At 24 months, the caries prevalence was 5% (3/61) in the CHX and 7% (4/58) in the controls (P = 0.7). There were no differences in percentages of MS-positive children between the CHX and control groups (54%vs 53%). Only 20% applied the CHX gel once daily and 80% less than once daily. Conclusions Toothbrushing using 304% fluoride toothpaste with or without the application of chlorhexidine gel (0.12%) reduces ECC from 23% found in the general community to 5–7%. The lack of effect with chlorhexidine is likely to be due to low compliance.
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Background Malnutrition is common in patients with advanced epithelial ovarian cancer (EOC), and is associated with impaired quality of life (QoL), longer hospital stay and higher risk of treatment-related adverse events. This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL. Methods From 2009 to 2013, 109 patients requiring surgery for suspected advanced EOC, moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention (n = 53) or control (n = 56) groups. Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained. Despite being randomised to intervention, 20 patients did not receive feeds (13 did not receive the feeding tube; 7 had it removed early). Control involved postoperative diet as tolerated. QoL was measured at baseline, 6 weeks postoperatively and 30 days after the third cycle of chemotherapy. The primary outcome measure was the difference in QoL between the intervention and the control group. Secondary endpoints included treatment-related adverse event occurrence, length of stay, postoperative services use, and nutritional status. Results Baseline characteristics were comparable between treatment groups. No significant difference in QoL was found between the groups at any time point. There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at 7 days postoperatively (11.8 intervention vs. 13.8 control, p 0.04). Conclusion Early enteral feeding did not significantly improve patients' QoL compared to standard of care but may improve nutritional status.
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Objective - We report the first randomised controlled trial (RCT) using a combination of St. John’s wort (SJW) and Kava for the treatment of major depressive disorder (MDD) with comorbid anxiety. Methods - Twenty-eight adults with MDD and co-occurring anxiety were recruited for a double-blind RCT. After a placebo run-in of 2 weeks, the trial had a crossover design testing SJW and Kava against placebo over two controlled phases, each of 4 weeks. The primary analyses used intention-to-treat and completer analyses. Results - On both intention-to-treat ( p¼0.047) and completer analyses ( p¼0.003), SJW and Kava gave a significantly greater reduction in self-reported depression on the Beck Depression Inventory (BDI-II) over placebo in the first controlled phase. However, in the crossover phase, a replication of those effects in the delayed medication group did not occur. Nor were there significant effects on anxiety or quality of life. Conclusion - There was some evidence of antidepressant effects using SJW and Kava in a small sample with comorbid anxiety. Possible explanations for the absence of anxiolysis may include a potential interaction with SJW, the presence of depression, or an inadequate dose of Kava.
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Background: The two-stage Total Laparoscopic Hysterectomy (TLH) versus Total Abdominal Hysterectomy (TAH) for stage I endometrial cancer (LACE) randomised controlled trial was initiated in 2005. The primary objective of stage 1 was to assess whether TLH results in equivalent or improved QoL up to 6 months after surgery compared to TAH. The primary objective of stage 2 was to test the hypothesis that disease-free survival at 4.5 years is equivalent for TLH and TAH. Results addressing the primary objective of stage 1 of the LACE trial are presented here. Methods: The first 361 LACE participants (TAH n= 142, TLH n=190) were enrolled in the QoL substudy at 19 centres across Australia, New Zealand and Hong Kong, and 332 completed the QoL analysis. Randomisation was performed centrally and independently from other study procedures via a computer generated, web-based system (providing concealment of the next assigned treatment) using stratified permuted blocks of 3 and 6, and assigned patients with histologically confirmed stage 1 endometrioid endometrial adenocarcinoma and ECOG performance status <2 to TLH or TAH stratified by histological grade and study centre. No blinding of patients or study personnel was attempted. QoL was measured at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The primary endpoint was the difference between the groups in QoL change from baseline at early and late time points (a 5% difference was considered clinically significant). Analysis was performed according to the intention-to-treat principle using generalized estimating equations on differences from baseline for the early and late QoL recovery. The LACE trial is registered with clinicaltrials.gov (NCT00096408) and the Australian New Zealand Clinical Trials Registry (CTRN12606000261516). Patients for both stages of the trial have now been recruited and are being followed up for disease-specific outcomes. Findings: The proportion of missing values at the 5%, 10% 15% and 20% differences in the FACT-G scale was 6% (12/190) in the TLH and 14% (20/142) in the TAH group. There were 8/332 conversions (2.4%, 7 of which were from TLH to TAH). In the early phase of recovery, patients undergoing TLH reported significantly greater improvement of QoL from baseline compared to TAH in all subscales except the emotional and social well-being subscales. Improvements in QoL up to 6 months post-surgery continued to favour TLH except for the emotional and social well-being of the FACT and the visual analogue scale of the EuroQoL five dimensions (EuroQoL-VAS). Length of operating time was significantly longer in the TLH group (138±43 mins), than in the TAH group at (109±34 mins; p=0.001). While the proportion of intraoperative adverse events was similar between the treatment groups (TAH 8/142, 5.6%; TLH 14/190, 7.4%; p=0.55), postoperatively, twice as many patients in the TAH group experienced adverse events of CTC grade 3+ than in the TLH group (33/142, 23.2% and 22/190, 11.6%, respectively; p=0.004). Postoperative serious adverse events occurred more frequently in patients who had a TAH (27/142, 19.0%) than a TLH (15/190, 7.9%) (p=0.002). Interpretation: QoL improvements from baseline during early and later phases of recovery, and the adverse event profile significantly favour TLH compared to TAH for patients treated for Stage I endometrial cancer.
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Aim: This paper is a report of a study conducted to determine the effectiveness of a community case management collaborative education intervention in terms of satisfaction, learning and performance among public health nurses. Background: Previous evaluation studies of case management continuing professional education often failed to demonstrate effectiveness across a range of outcomes and had methodological weaknesses such as small convenience samples and lack of control groups. Method: A cluster randomised controlled trial was conducted between September 2005 and February 2006. Ten health centre clusters (5 control, 5 intervention) recruited 163 public health nurses in Taiwan to the trial. After pre-tests for baseline measurements, public health nurses in intervention centres received an educational intervention of four half-day workshops. Post-tests for both groups were conducted after the intervention. Two-way repeated measures analysis of variance was performed to evaluate the effect of the intervention on target outcomes. Results: A total of 161 participants completed the pre- and post-intervention measurements. This was almost a 99% response rate. Results revealed that 97% of those in the experimental group were satisfied with the programme. There were statistically significant differences between the two groups in knowledge (p = 0.001), confidence in case management skills (p = 0.001), preparedness for case manager role activities (p = 0.001), self-reported frequency in using skills (p = 0.001), and role activities (p = 0.004). Conclusion: Collaboration between academic and clinical nurses is an effective strategy to prepare nurses for rapidly-changing roles.
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Background Exercise for Health was a pragmatic, randomised, controlled trial comparing the effect of an eight-month exercise intervention on function, treatment-related side effects and quality of life following breast cancer, compared with usual care. The intervention commenced six weeks post-surgery, and two modes of delivering the same intervention was compared with usual care. The purpose of this paper is to describe the study design, along with outcomes related to recruitment, retention and representativeness, and intervention participation. Methods: Women newly diagnosed with breast cancer and residing in a major metropolitan city of Queensland, Australia, were eligible to participate. Consenting women were randomised to a face-to-face-delivered exercise group (FtF, n=67), telephone-delivered exercise group (Tel, n=67) or usual care group (UC, n=60) and were assessed pre-intervention (5-weeks post-surgery), mid-intervention (6 months post-surgery) and 10 weeks post-intervention (12 months post-surgery). Each intervention arm entailed 16 sessions with an Exercise Physiologist. Results: Of 318 potentially eligible women, 63% (n=200) agreed to participate, with a 12-month retention rate of 93%. Participants were similar to the Queensland breast cancer population with respect to disease characteristics, and the randomisation procedure was mostly successful at attaining group balance, with the few minor imbalances observed unlikely to influence intervention effects given balance in other related characteristics. Median participation was 14 (min, max: 0, 16) and 13 (min, max: 3, 16) intervention sessions for the FtF and Tel, respectively, with 68% of those in Tel and 82% in FtF participating in at least 75% of sessions. Discussion: Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women. Future work, designed to inform translation into practice, will evaluate the quality of life, clinical, psychosocial and behavioural outcomes associated with each mode of delivery.
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Background Along with reduced levels of physical activity, older Australian's mean energy consumption has increased. Now over 60% of older Australians are considered overweight or obese. This study aims to confirm if a low-cost, accessible physical activity and nutrition program can improve levels of physical activity and diet of insufficiently active 60-70 year-olds. Methods/Design This 12-month home-based randomised controlled trial (RCT) will consist of a nutrition and physical activity intervention for insufficiently active people aged 60 to 70 years from low to medium socio-economic areas. Six-hundred participants will be recruited from the Australian Federal Electoral Role and randomly assigned to the intervention (n = 300) and control (n = 300) groups. The study is based on the Social Cognitive Theory and Precede-Proceed Model, incorporating voluntary cooperation and self-efficacy. The intervention includes a specially designed booklet that provides participants with information and encourages dietary and physical activity goal setting. The booklet will be supported by an exercise chart, calendar, bi-monthly newsletters, resistance bands and pedometers, along with phone and email contact. Data will be collected over three time points: pre-intervention, immediately post-intervention and 6-months post-study. Discussion This trial will provide valuable information for community-based strategies to improve older adults' physical activity and dietary intake. The project will provide guidelines for appropriate sample recruitment, and the development, implementation and evaluation of a minimal intervention program, as well as information on minimising barriers to participation in similar programs.