Patient education to prevent falls among older hospital inpatients : a randomized controlled trial

Background Falls are a common adverse event during hospitalization of older adults, and few interventions have been shown to prevent then. Methods This study was a 3-group randomized trial to evaluate the efficacy of 2 forms of multimedia patient education compared with usual care for the prevention of in-hospital falls. Older hospital patients (n = 1206) admitted to a mixture of acute (orthopedic, respiratory, and medical) and subacute (geriatric and neurorehabilitation) hospital wards at 2 Australian hospitals were recruited between January 2008 and April 2009. The interventions were a multimedia patient education program based on the health-belief model combined with trained health professional follow-up (complete program), multi-media patient education materials alone (materials only), and usual care (control). Falls data were collected by blinded research assistants by reviewing hospital incident reports, hand searching medical records, and conducting weekly patient interviews. Results Rates of falls per 1000 patient-days did not differ significantly between groups (control, 9.27; materials only, 8.61; and complete program, 7.63). However, there was a significant interaction between the intervention and presence of cognitive impairment. Falls were less frequent among cognitively intact patients in the complete program group (4.01 per 1000 patient-days) than among cognitively intact patients in the materials-only group (8.18 per 1000 patient-days) (adjusted hazard ratio, 0.51; 95% confidence interval, 0.28-0.93]) and control group (8.72 per 1000 patient-days) (adjusted hazard ratio, 0.43; 95% confidence interval, 0.24-0.78). Conclusion Multimedia patient education with trained health professional follow-up reduced falls among patients with intact cognitive function admitted to a range of hospital wards.

MobileMums: A randomized controlled trial of an SMS-based physical activity intervention

Background Postnatal women (<12 months postpartum) are at increased risk of physical inactivity. Purpose To evaluate the efficacy and feasibility of a theory-based physical activity (PA) intervention delivered to postnatal women primarily via mobile telephone short message service (SMS). Methods Eighty-eight women were randomized to the intervention (n=45) or minimal contact control (n=43) condition. The 12-week intervention consisted of a face-to-face PA goal-setting consultation, a goal-setting magnet, three to five personally tailored SMS/week and a nominated support person who received two SMS per week. SMS content targeted constructs of social cognitive theory. Frequency (days/week) and duration (min/week) of PA participation and walking for exercise were assessed via self-report at baseline, 6 and 13 weeks. Results Intervention participants increased PA frequency by 1.82 days/week (SE±0.18) by 13 weeks (F(2,85)=4.46, p=0.038) and walking for exercise frequency by 1.08 days/ week (SE±0.24) by 13 weeks (F(2,85)=5.38, p=0.02). Positive trends were observed for duration (min/week) of PA and walking for exercise. Conclusions Intervention exposure resulted in increased frequency of PA and walking for exercise in postnatal women.

Physical activity and nutrition program for seniors (PANS) : protocol of a randomized controlled trial

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.

Living well with diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes

Background By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps. Methods/Design Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013. Discussion This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health behaviour change, and will build the evidence base needed to advocate for the translation of this work into population health practice.

Does the effect of weight lifting on lymphedema following breast cancer differ by diagnostic method: results from a randomized controlled trial

The lymphedema diagnostic method used in descriptive or intervention studies may influence results found. The purposes of this work were to compare baseline lymphedema prevalence in the physical activity and lymphedema (PAL) trial cohort and to subsequently compare the effect of the weight-lifting intervention on lymphedema, according to four standard diagnostic methods. The PAL trial was a randomized controlled intervention study, involving 295 women who had previously been treated for breast cancer, and evaluated the effect of 12 months of weight lifting on lymphedema status. Four diagnostic methods were used to evaluate lymphedema outcomes: (i) interlimb volume difference through water displacement, (ii) interlimb size difference through sum of arm circumferences, (iii) interlimb impedance ratio using bioimpedance spectroscopy, and (iv) a validated self-report survey. Of the 295 women who participated in the PAL trial, between 22 and 52% were considered to have lymphedema at baseline according to the four diagnostic criteria used. No between-group differences were noted in the proportion of women who had a change in interlimb volume, interlimb size, interlimb ratio, or survey score of ≥5, ≥5, ≥10%, and 1 unit, respectively (cumulative incidence ratio at study end for each measure ranged between 0.6 and 0.8, with confidence intervals spanning 1.0). The variation in proportions of women within the PAL trial considered to have lymphoedema at baseline highlights the potential impact of the diagnostic criteria on population surveillance regarding prevalence of this common morbidity of treatment. Importantly though, progressive weight lifting was shown to be safe for women following breast cancer, even for those at risk or with lymphedema, irrespective of the diagnostic criteria used.

Inflammatory cytokine responses to progressive resistance training and supplementation with fortified milk in men aged 50+ years : an 18-month randomized controlled trial

We examined the effects of progressive resistance training (PRT) and supplementation with calcium-vitamin D(3) fortified milk on markers of systemic inflammation, and the relationship between inflammation and changes in muscle mass, size and strength. Healthy men aged 50-79 years (n = 180) participated in this 18-month randomized controlled trial that comprised a factorial 2 x 2 design. Participants were randomized to (1) PRT + fortified milk supplement, (2) PRT, (3) fortified milk supplement, or (4) a control group. Participants assigned to PRT trained 3 days per week, while those in the supplement groups consumed 400 ml day(-1) of milk containing 1,000 mg calcium plus 800 IU vitamin D(3). We collected venous blood samples at baseline, 12 and 18 months to measure the serum concentrations of IL-6, TNF-alpha and hs-CRP. There were no exercise x supplement interactions, but serum IL-6 was 29% lower (95% CI, -62, 0) in the PRT group compared with the control group after 12 months. Conversely, IL-6 was 31% higher (95% CI, -2, 65) in the supplement group compared with the non-supplemented groups after 12 and 18 months. These between-group differences did not persist after adjusting for changes in fat mass. In the PRT group, mid-tibia muscle cross-sectional area increased less in men with higher pre-training inflammation compared with those men with lower inflammation (net difference similar to 2.5%, p < 0.05). In conclusion, serum IL-6 concentration decreased following PRT, whereas it increased after supplementation with fortified milk concomitant with changes in fat mass. Furthermore, low-grade inflammation at baseline restricted muscle hypertrophy following PRT.

Exercise for health : a randomized, controlled trial evaluating impact of a pragmatic, translational exercise intervention on quality of life, function and treatment-related side effects following breast cancer

Purpose Exercise for Health was a randomized, controlled trial designed to evaluate two modes of delivering (face-to-face [FtF] and over-the-telephone [Tel]) an 8-month translational exercise intervention, commencing 6-weeks post-breast cancer surgery (PS). Methods Outcomes included quality of life (QoL), function (fitness and upper-body) and treatment-related side effects (fatigue, lymphoedema, body mass index, menopausal symptoms, anxiety, depression and pain). Generalised estimating equation modelling determined time (baseline [5-weeks PS], mid-intervention [6-months PS], post-intervention [12-months PS]), group (FtF, Tel, Usual Care [UC]) and time-by-group effects. 194 women representative of the breast cancer population were randomised to the FtF (n=67), Tel (n=67) and UC (n=60) groups. Results: There were significant (p<0.05) interaction effects on QoL, fitness and fatigue, with differences being observed between the treatment groups and the UC group. Trends observed for the treatment groups were similar. The treatment groups reported improved QoL, fitness and fatigue over time and changes observed between baseline and post-intervention were clinically relevant. In contrast, the UC group experienced no change, or worsening QoL, fitness and fatigue, mid-intervention. Although improvements in the UC group occurred by 12-months post-surgery, the change did not meet the clinically relevant threshold. There were no differences in other treatment-related side-effects between groups. Conclusion This translational intervention trial, delivered either face-to-face or over-the-telephone, supports exercise as a form of adjuvant breast cancer therapy that can prevent declines in fitness and function during treatment and optimise recovery post-treatment.

Clinical trial of the Norton Scale in acute care settings

This study investigated the effect of using Norton Scale assessment data in the nursing care of patients at risk of developing pressure ulcers. The results indicated that incorporating the Norton Scale in care planning resulted in benefits to patients through earlier and more effective nursing interventions.

The effect of Tai Chi on health related quality of life in people with elevated blood glucose or diabetes : a randomized controlled trial

Purpose The aim was to assess the effects of a Tai Chi based program on health related quality of life (HR-QOL) in people with elevated blood glucose or diabetes who were not on medication for glucose control. Method 41 participants were randomly allocated to either a Tai Chi intervention group (N = 20) or a usual medical care control group (N = 21). The Tai Chi group involved 3 x 1.5 hour supervised and group-based training sessions per week for 12 weeks. Indicators of HR-QOL were assessed by self-report survey immediately prior to and after the intervention. Results There were significant improvements in favour of the Tai Chi group for the SF36 subscales of physical functioning (mean difference = 5.46, 95% CI = 1.35-9.57, P < 0.05), role physical (mean difference = 18.60, 95% CI = 2.16-35.05, P < 0.05), bodily pain (mean difference = 9.88, 95%CI = 2.06-17.69, P < 0.05) and vitality (mean difference = 9.96, 95% CI = 0.77-19.15, P < 0.05). Conclusions The findings show that this Tai Chi program improved indicators of HR-QOL including physical functioning, role physical, bodily pain and vitality in people with elevated blood glucose or diabetes who were not on diabetes medication.

Exploring the effect of companion robots on emotional expression in older people with dementia : a pilot randomized controlled trial

This pilot study aimed to compare the effect of companion robots (PARO) to participation in an interactive reading group on emotions in people living with moderate to severe dementia in a residential care setting. A randomized crossover design, with PARO and reading control groups, was used. Eighteen residents with mid- to late-stage dementia from one aged care facility in Queensland, Australia, were recruited. Participants were assessed three times using the Quality of Life in Alzheimer’s Disease, Rating Anxiety in Dementia, Apathy Evaluation, Geriatric Depression, and Revised Algase Wandering Scales. PARO had a moderate to large positive influence on participants’ quality of life compared to the reading group. The PARO intervention group had higher pleasure scores when compared to the reading group. Findings suggest PARO may be useful as a treatment option for people with dementia; however, the need for a larger trial was identified.