Six-month Intervention Research Articles

Rational Clinical Pathology Assessment in the Intensive Care Unit.

Blood tests are ordered on a daily basis in intensive care units (ICU). There are no widely accepted guidelines for testing requirements. This study investigated the impact on ICU laboratory test costs of a multi-strategy change in practice involving routine blood testing. A single centre, prospective, interventional study using historical controls was undertaken to investigate the impact of ICU specialist authorisation of high-volume routine tests on ICU laboratory test costs. Prior to commencement of the study, ICU nursing and junior ICU doctors were able to order tests. During the six-month intervention period, the ICU specialists authorised routine blood tests. Adverse events related to not performing blood tests were also recorded. Overall ICU laboratory test costs decreased by 12.3% over the six months (P=0.0022 versus historical control) with a mean compliance of 51% with the test authorisation protocol. The costs of frequently ordered tests (classified as high-volume) decreased by 20% (P=0.0022 versus historical control). These accounted for an average of 54 ± 3% of the overall ICU blood test costs (blood gas analyses 17%, simple chemistry tests consisting of electrolytes, liver function, calcium, phosphate, magnesium 14%, coagulation 12% and full blood count 11%). Two protocol-related adverse events were recorded and judged as minor and were resolved by ordering tests during the day. No adverse patient outcomes resulted from these two events. Blood testing authorisation by an ICU specialist was associated with significant cost savings in ICU and no adverse patient outcomes.

Behaviour change intervention to improve shared toilet maintenance and cleanliness in urban slums of Dhaka: a cluster-randomised controlled trial.

Shared toilets in urban slums are often unclean and poorly maintained, discouraging consistent use and thereby limiting impacts on health and quality of life. We developed behaviour change interventions to support shared toilet maintenance and improve user satisfaction. We report the intervention effectiveness on improving shared toilet cleanliness. We conducted a cluster-randomised controlled trial among users of 1226 shared toilets in 23 Dhaka slums. We assessed baseline toilet cleanliness in January 2015. The six-month intervention included provision of hardware (bin for solid waste, 4 l flushing bucket, 70 l water reservoir), and behaviour change communication (compound meetings, interpersonal household sessions, signs depicting rules for toilet use). We estimated the adjusted difference in difference (DID) to assess outcomes and accounted for clustering effects using generalised estimating equations. Compared to controls, intervention toilets were more likely to have water available inside toilet cubicles (DID: +4.7%, 95% CI: 0.2, 9.2), access to brush/broom for cleaning (DID: +8.4%, 95% CI: 2, 15) and waste bins (DID: +63%, 95% CI: 59, 66), while less likely to have visible faeces inside the pan (DID: -13%, 95% CI: -19, -5), the smell of faeces (DID: -7.6%, 95% CI: -14, -1.3) and household waste inside the cubicle (DID: -4%, 95% CI: -7, -1). In one of few efforts to promote shared toilet cleanliness, intervention compounds were significantly more likely to have cleaner toilets after six months. Future research might explore how residents can self-finance toilet maintenance, or employ mass media to reduce per-capita costs of behaviour change.

Oxidative stress reduction related to the efficacy of n-3 polyunsaturated fatty acids in first episode schizophrenia: Secondary outcome analysis of the OFFER randomized trial

Intervention studies of n-3 polyunsaturated fatty acids (n-3 PUFA) as add-on therapy in patients with schizophrenia have not examined changes in oxidative stress. A randomized placebo-controlled trial of a 26-week intervention composed of 2.2g/day of n-3 PUFA was found to reduce symptom severity in first-episode schizophrenia patients. The present study is an extension of our previous report, whose secondary aim was to assess the association between the clinical effect of n-3 PUFA and changes in oxidative stress indices. Seventy-one patients aged 16–35 were enrolled in the study and randomly assigned to the study arms. Total plasma antioxidant capacity and 8-epi-isoprostane F2α content were assessed at baseline and at weeks 8 and 26 of the study as secondary outcome measures. Significant changes in oxidative stress indices favouring the intervention group were observed: decreases in 8-isoprostane F2α (p<0.001) and increases in total plasma antioxidant capacity (p<0.001). Significant correlations between changes in clinical scores relevant to symptom severity and changes in oxidative indices were observed. The results of the present study hence suggest that the efficacy of a six-month intervention with n-3 PUFA observed in first-episode schizophrenia may be related to improvement in oxidative stress indices.

Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads.

BackgroundA growing number of older adults use in-home Medicaid Waiver Home and Community Based services (HCBS) to facilitate aging-in-place. A primary service of this program is Home Care Aide assistance with activities of daily living and homemaker needs. Despite the known benefits of exercise, exercise programs are currently not offered to clients in the Medicaid Waiver system. Thus, the purpose of this paper is to describe a six-month Home Care Aide-led resistance exercise intervention protocol for frail older adults receiving Medicaid waiver services.Methods/designA randomized controlled trial will be used. We will enroll 126 Home Care Aide-client dyads for a 6-month exercise intervention. The intervention will consist of training phases to promote muscle strength, power, and endurance. We will use an intention to treat principle using mixed effects models for the quantitative outcomes. To analyze qualitative outcomes, we will use conventional content analysis to examine themes from participant program evaluations.DiscussionAs greater numbers of adults age in place with frailty and employ Home Care Aides to help manage functional limitations, interventions embedded within usual care services play a critical role in bringing exercise into the home setting. The research described in this protocol will provide important knowledge about the impact of a Home Care Aide-led exercise intervention in reducing frailty in older adults.Clinical Trials RegistrationClinicalTrials.gov Identifier: NCT02942992;

Design of a randomized trial to determine the optimum protein intake to preserve lean body mass and to optimize response to a promyogenic anabolic agent in older men with physical functional limitation

The dietary protein allowance for older men to maintain lean body mass and muscle strength and to accrue optimal anabolic responses to promyogenic stimuli is poorly characterized. The OPTIMEN trial was designed to assess in older men with moderate physical dysfunction and insufficient habitual protein intake (<recommended dietary allowance, RDA, 0.8g·kg−1·d−1) the efficacy of consuming diets containing 163% RDA (1.3g·kg−1·d−1) for protein, compared to RDA, to increase lean mass, muscle performance, and physical function. A second aim was to determine whether increasing protein intake to 1.3 versus 0.8g·kg−1·d−1 would augment anabolic responses to a promyogenic agent, testosterone.For this randomized, double-blind, placebo-controlled six-month intervention trial, 92 men, 65years or older, with Short Physical Performance Battery scores 3–10, and habitual protein intakes <RDA, were assigned to one of four groups: 100% RDA plus placebo intramuscular injections weekly; 100% RDA plus weekly intramuscular injections of 100mg testosterone enanthate; 163% RDA plus placebo injections; or 163% RDA plus testosterone injections. All participants received portion-controlled packaged meals and group-specific dietary supplements containing either mixtures of casein and whey or carbohydrate, with identical appearance. The primary outcome was change in lean body mass assessed using dual energy X-ray absorptiometry. Secondary outcomes included maximal voluntary strength and power in leg press and chest press exercises, 6-minute walking distance, stair climbing power, and self-reported physical function.Results of the OPTIMEN trial have important implications for dietary protein guidance and policy, and efficacy of promyogenic drugs.

Influence of lifestyle intervention on cardiovascular risk factors for perimenopausal women

Objective To explore the effect of lifestyle intervention on risk factors for cardiovascular diseases in perimenopausal women, so as to determine the healthy lifestyle for them. Methods From March to December 2015, by cluster sampling, 130 perimenopausal women in Changchun were selected and divided randomly into experimental group (n=66) and control group (n=64) . Conventional health education was conducted by community nurses to those in the control group, while those in the experimental group were given health education lectures, with lifestyle intervention schemes made on an individual basis. After the six-month intervention, lifestyles and indexes such as blood pressure, blood fat, etc. were compared between the two groups. Results Lifestyle comparison of perimenopausal women in the control group showed no statistic significance before and after the intervention (P>0.05) , while in the experimental group, there was (P 0.05) , while after the intervention, there was (P 0.05) , while comparison of systolic pressure, body weight, waist hip rate and total cholesterol level in the experimental group showed statistic significance before and after the intervention (P 0.05) . while after the intervention, comparison of waist hip rate, systolic pressure, and body weight between the two groups showed statistic significance (P 0.05) . Conclusions Lifestyle intervention can significantly reduce cardiovascular disease risk factors for perimenopausal women. Key words: Life style; Perimenopause; Cardiovascular diseases

Effects of home-based exercise rehabilitation on anxiety in coronary heart disease patients after PCI

Objective To explore the effects of home-based exercise rehabilitation on anxiety in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) , and to improve both mental health and heart rehabilitation of the patients. Methods Totals of 108 patients who were diagnosed with CHD in Renmin hospital of Wuhan university and should have received PCI were recruited into the study from December 2013 to December 2015. The participants were randomly divided into two groups: intervention group (n=54) and control group (n=54). Based on the routine nursing care and discharged education, the intervention group also received home-based exercise rehabilitation with regular follow-up and supervision for exercise. The basic information, self-rating anxiety scale (SAS) and exercise situation were documented and assessed before the intervention, as well as three months and six months after the intervention. Results 48 patients in the experimental group and 46 patients in the control group completed the study. Within the group effect: the SAS had a significant difference (P 0.05). Within the time effect: both SAS and exercise related indicators demonstrated statistical differences between each time point (P 0.05). The intervention group patients performed better exercise compliance (i.e. frequency, duration, intensity, self-protection, warm-up and relaxation exercise) after a six-month intervention, compared with the compliance before the intervention (P<0.05) . Conclusions Home-based exercise rehabilitation can effectively alleviate patients' anxiety, and can also improve patients' cardiovascular function and reduce their blood pressure. The regular telephone follow-up and health education can better improve patients' adherence to the home-based exercise rehabilitation. Key words: Anxiety; Home-based exercise rehabilitation; Coronary heart disease; Percutaneous coronary intervention

Physical Exercise with Music Maintains Activities of Daily Living in Patients with Dementia: Mihama-Kiho Project Part 21.

Recent studies suggest that combined non-pharmacological interventions are more beneficial than single interventions for primary and secondary prevention of dementia. We previously reported enhanced effects of physical exercise with music (ExM) on cognitive function in normal elderly people compared to exercise alone. To identify if ExM improves cognitive function and activities of daily livings (ADLs) in dementia patients over cognitive stimulation (CS). We enrolled 85 patients with mild to moderate dementia. Forty-three subjects performed ExM developed by the Yamaha Music Foundation, and 42 subjects performed cognitive stimulation using portable game consoles and drills involving easy calculations, mazes, and mistake-searching in pictures. Interventions were performed once a week for 40 minutes. Before and after the six-month intervention, patients were assessed using neuropsychological batteries, and ADLs were assessed by patients' caregivers using the functional independence measure (FIM). Voxel-based specific regional analysis system for Alzheimer's disease (VSRAD) was used to assess medial temporal lobe atrophy. Twenty-three subjects dropped out during the intervention. Thirty-one patients from each group were analyzed. Post-intervention, both groups showed significantly improved visuospatial function. Significant benefits were observed in psychomotor speed or memory in the ExM or CS groups, respectively. FIM scores, reflecting ADLs, and VSRAD scores were significantly preserved in the ExM group, but significantly worsened in the CS group. ExM produced greater positive effects on cognitive function and ADLs in patients with mild to moderate dementia than CS, excluding memory. Optimal interventions for dementia will likely be achieved by combining ExMand CS.

Public health care system, a quasi-experimental study: Acceptance and attitude to implicate clinical services.

A six-month longitudinal intervention arm study with a pre-post cross-sectional questionnaire-based survey was performed. A 3-phase objective structured clinical examination (OSCE) design was utilized for evaluation of acceptance and attitude of pharmacy students towards clinical pharmacy services. The pre-OSCE survey showed increased disagreement with the role of clinical pharmacists, compared to a significant positive shift in attitude towards their services in the healthcare team after 6 months of the trial. Responses improved for awareness (the current healthcare system could be improved by involving pharmacists, p < 0.02) and positive attitude categories (doctors and nurses would be happy to welcome the services of competent clinical pharmacists as part of their team, p < 0.01) in addition to competency (pharmacists have sufficient clinical training to advise doctors and nurses, p < 0.01). The predictive model suggested a strong positive effect on patient interaction, medical information tasks, clinical decisions on drug-related problems (DRPs), and communication with healthcare professionals (R2 = 0.41, F = 1.51, p < 0.001).

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention

Objective: Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology.Design: Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants.Main Outcome Measures: Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models.Results: TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13–20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6–38%) and behaviour (average 30%, range 6–55%) were significant.Conclusion: Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases.

Exercise intervention implemented by trained volunteers improves health-related quality of life among Japanese community-dwelling older females: an intervention study.

[Purpose] This study aimed to evaluate the sustainability and efficacy of exercise intervention, as implemented by professionally trained volunteers, on the health-related quality of life among Japanese community-dwelling older females. [Subjects and Methods] We conducted a non-randomized observational prospective study of a six-month exercise intervention delivered by volunteers or health professionals. Health-related quality of life was scored using the Short Form 36 Health Survey before and after the intervention. Participants were classified into three groups, comprising those with improved health, maintained health, and reduced health. [Results] Among 127 Japanese community-dwelling females aged >65 years, 50 of 62 (80.6%) females involved in the intervention conducted by volunteers, and 55 of 65 (84.6%) females involved in the intervention conducted by health professionals, completed the six-month intervention program. Scoring revealed that interventions by both volunteers and health professionals had a maintaining or improving effect on scores in >70% of participants instead of an expected six-month aging decline. [Conclusion] Exercise intervention by trained volunteers was sustainable and effective for improving the health-related quality of life among Japanese community-dwelling older females. Professionally trained volunteers could benefit communities in helping older persons avoid the need for daily nursing care through promoting health activities.

Association of the Composite Inflammatory Biomarker GlycA, with Exercise-Induced Changes in Body Habitus in Men and Women with Prediabetes.

GlycA is a new composite measure of systemic inflammation and a predictor of many inflammatory diseases. GlycA is the nuclear magnetic resonance spectroscopy-derived signal arising from glucosamine residues on acute-phase proteins. This study aimed to evaluate how exercise-based lifestyle interventions modulate GlycA in persons at risk for type 2 diabetes. GlycA, fitness, and body habitus were measured in 169 sedentary adults (45–75 years) with prediabetes randomly assigned to one of four six-month exercise-based lifestyle interventions. Interventions included exercise prescription based on the amount (energy expenditure (kcal/kg weight/week (KKW)) and intensity (%VO2peak). The groups were (1) low-amount/moderate-intensity (10KKW/50%) exercise; (2) high-amount/moderate-intensity (16KKW/50%) exercise; (3) high-amount/vigorous-intensity (16KKW/75%) exercise; and (4) a Clinical Lifestyle (combined diet plus low-amount/moderate-intensity exercise) intervention. Six months of exercise training and/or diet-reduced GlycA (mean Δ: −6.8 ± 29.2 μmol/L; p = 0.006) and increased VO2peak (mean Δ: 1.98 ± 2.6 mL/kg/min; p < 0.001). Further, visceral (mean Δ: −21.1 ± 36.6 cm2) and subcutaneous fat (mean Δ: −24.3 ± 41.0 cm2) were reduced, while liver density (mean Δ: +2.3 ± 6.5HU) increased, all p < 0.001. When including individuals in all four interventions, GlycA reductions were associated with reductions in visceral adiposity (p < 0.03). Exercise-based lifestyle interventions reduced GlycA concentrations through mechanisms related to exercise-induced modulations of visceral adiposity. This trial is registered with Clinical Trial Registration Number NCT00962962.

Physical activity and nutrition program for adults with metabolic syndrome: Process evaluation

IntroductionThe Vietnam Physical Activity and Nutrition (VPAN) program aimed to improve physical activity and nutrition for adults aged 50–65 years with Metabolic Syndrome in Vietnam. The VPAN program consisted of a range of resources and strategies, including an information booklet, resistance band, face-to-face education sessions, and walking groups. This process evaluation assessed the participation, fidelity, satisfaction, and reasons for completing and not-completing the VPAN. MethodsData were collected by mixed-methods from a sample of 214 intervention participants. Quantitative data were collected via surveys (n=163); qualitative data via face-to-face exit interviews with intervention program completers (n=10) and non-completers (n=10), and brief post education session discussions. ResultsMost participants (87%–96%) reported the program resources and strategies useful, assisting them to increase their physical activity level and improving their diet. The education sessions were the most preferred strategy (97%) with high attendance (>78% of participants). The main reasons for withdrawal were work commitments and being too busy. ConclusionThe evaluation indicated that the program reached and engaged the majority of participants throughout the six-month intervention. The combination of printed resources and face-to-face intervention components was a suitable approach to support lifestyle behavioural change in the Vietnamese population.

Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

BackgroundThe North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS) includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE) showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis.ObjectivesTo determine the effect of a six-month Schroth PSSE intervention added to standard of care (Experimental group) on the Cobb angle compared to standard of care alone (Control group) in patients with AIS.MethodsFifty patients with AIS aged 10–18 years, with curves of 10°-45° and Risser grade 0–5 were recruited from a single pediatric scoliosis clinic and randomized to the Experimental or Control group. Outcomes included the change in the Cobb angles of the Largest Curve and Sum of Curves from baseline to six months. The intervention consisted of a 30–45 minute daily home program and weekly supervised sessions. Intention-to-treat and per protocol linear mixed effects model analyses are reported.ResultsIn the intention-to-treat analysis, after six months, the Schroth group had significantly smaller Largest Curve than controls (-3.5°, 95% CI -1.1° to -5.9°, p = 0.006). Likewise, the between-group difference in the square root of the Sum of Curves was -0.40°, (95% CI -0.03° to -0.8°, p = 0.046), suggesting that an average patient with 51.2° at baseline, will have a 49.3° Sum of Curves at six months in the Schroth group, and 55.1° in the control group with the difference between groups increasing with severity. Per protocol analyses produced similar, but larger differences: Largest Curve = -4.1° (95% CI -1.7° to -6.5°, p = 0.002) and (95% CI -0.8 to 0.2, p = 0.006).ConclusionSchroth PSSE added to the standard of care were superior compared to standard of care alone for reducing the curve severity in patients with AIS.Trial RegistrationNCT01610908

The Impact of Health Literacy Status on the Comparative Validity and Sensitivity of an Interactive Multimedia Beverage Intake Questionnaire.

Self-reported dietary assessment methods can be challenging to validate, and reporting errors for those with lower health literacy (HL) may be augmented. Interactive multimedia (IMM) based questionnaires could help overcome these limitations. The objectives of this investigation are to assess the comparative validity and sensitivity to change of an IMM beverage intake questionnaire (IMM-BEVQ) as compared to dietary recalls and determine the impact of HL. Adults completed three 24-h dietary recalls and the IMM-BEVQ at baseline and after a six-month intervention targeting either sugar-sweetened beverages (SSB) or physical activity. Correlations and paired-samples t-tests are presented. For validity (n = 273), intake of SSB (mean difference = 10.6 fl oz) and total beverage consumption (mean difference = 16.0 fl oz) were significantly different (p ≤ 0.001) at baseline between the IMM-BEVQ and dietary recalls for all participants. However, the differences in intake were generally greater in low HL participants than in adequate HL participants. For sensitivity (n = 162), change in SSB intake (mean difference = 7.2 fl oz) was significantly different (p ≤ 0.01) between pre-/post-IMM-BEVQ and pre-/post-dietary recalls, but not total beverage intake (mean difference = 7.6 fl oz) for all participants. Changes in SSB and total beverage intake were not significantly different for those with adequate HL. The IMM-BEVQ is a valid dietary assessment tool that is as responsive to detecting changes in beverage intake as dietary recalls. However, adults with lower HL may need additional guidance when completing the IMM-BEVQ.

Effect of Six-Month Diet Intervention on Sleep among Overweight and Obese Men with Chronic Insomnia Symptoms: A Randomized Controlled Trial.

Growing evidence suggests that diet alteration affects sleep, but this has not yet been studied in adults with insomnia symptoms. We aimed to determine the effect of a six-month diet intervention on sleep among overweight and obese (Body mass index, BMI ≥ 25 kg/m2) men with chronic insomnia symptoms. Forty-nine men aged 30–65 years with chronic insomnia symptoms were randomized into diet (n = 28) or control (n = 21) groups. The diet group underwent a six-month individualized diet intervention with three face-to-face counseling sessions and online supervision 1–3 times per week; 300–500 kcal/day less energy intake and optimized nutrient composition were recommended. Controls were instructed to maintain their habitual lifestyle. Sleep parameters were determined by piezoelectric bed sensors, a sleep diary, and a Basic Nordic sleep questionnaire. Compared to the controls, the diet group had shorter objective sleep onset latency after intervention. Within the diet group, prolonged objective total sleep time, improved objective sleep efficiency, lower depression score, less subjective nocturnal awakenings, and nocturia were found after intervention. In conclusion, modest energy restriction and optimized nutrient composition shorten sleep onset latency in overweight and obese men with insomnia symptoms.

Sexual health of endometrial cancer survivors before and after a physical activity intervention: A retrospective cohort analysis

ObjectiveSexual dysfunction is common in endometrial cancer survivors (ECS). Our group previously tested a six-month exercise intervention in ECS. We performed a secondary analysis to determine intervention's impact on sexual health. MethodsWe studied 100 post-treatment Stage I-IIIa sedentary ECS who participated in a non-controlled, single-arm, home-based exercise intervention utilizing telephone counseling, printed material, and pedometers. Quality-of-life and physical activity measures were collected at baseline and six months. Sexual function (SF) and sexual interest (SI) scores were extracted from the QLACS questionnaire. ResultsBaseline SF and SI were lower in survivors with less than a four-year college degree (P<0.001). Baseline SI was higher in survivors who were married or living with a significant other (P=0.012). No significant differences in SF or SI were observed based on obesity status, race, time since diagnosis, or treatment type. Post-intervention, mean SF score improved (P=0.002), 51% of participants had improved SI, and 43% had improved SF. When controlled for age and time since diagnosis, a one-hour increase in weekly physical activity was associated with a 6.5% increased likelihood of improved SI (P=0.04). Increased physical activity was not associated with improved SF. ConclusionsAlthough causation cannot be determined in this study, the correlation between receipt of an exercise intervention and improved sexual health for ECS is a novel finding. This finding suggests a role for physical activity as a strategy to improve the sexual health of ECS, which our group is examining in a larger prospective study.

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records.

Long-term assessment of prostaglandin analogs and timolol fixed combinations vs prostaglandin analogs monotherapy.

To draw a Meta-analysis over the comparison of the intraocular pressure (IOP)-lowering efficacy and safety between the commonly used fixed-combinations of prostaglandin analogs and 0.5% timolol with prostaglandin analogs (PGAs) monotherapy. After searching the published reports from MEDLINE, EMBASE, the Cochrane Library, all randomized controlled clinical trials (RCTs) comparing the fixed combination of PGAs/timolol therapy (FCs) and PGAs monotherapy with treatment duration at least 6mo were included. The efficacy outcomes were mean diurnal IOP, percentage of participants whose IOP were lower than 18 mm Hg, incidence of visual field change, while the safety outcomes included corneal side effects, hyperemia and eye irritation. The analysis was carried out in RevMan version 5.3 software. After six-month medical intervention, the mean diurnal IOP of FCs was lower than PGAs (MD -1.14, 95% CI -1.82 to -0.46, P=0.001); the percentage of target IOP achieving between FCs and PGAs showed no significant difference (RR 1.18, 95% CI 0.97 to 1.43, P=0.10). No statistically significant differences of the incidence of hyperemia (RR 0.67, 95% CI 0.45 to 1.01, P=0.06) and eye irritation (RR 1.20, 95% CI 0.95 to 1.51, P=0.12) between the FCs and PGAs monotherapy were detected. Only one research involved in corneal events, result of this trial revealed no difference between two intervention groups regarding corneal effects (central endothelial cell density, MD -0.20, 95% CI -0.72 to 0.32, P=0.45; central corneal thickness, MD -0.01, 95% CI -0.02 to 0.00, P=0.23). The evaluation of visual field change was not performed due to the limited duration of the trials included in this Meta-analysis. The long-term efficacy of the FCs overweighed the PGAs monotherapy in lowering IOP, but in the incidence of hyperemia and eye irritation syndromes, the differences are not statically significant. More RCTs with detailed and authentic data over the assessments of visual functions and morphology of optic nerve heads are hoped to be conducted.

Psychosocial mediators of a theory-based resistance training maintenance intervention for prediabetic adults

Objective: Examine psychosocial mediators of the effects of high vs. low-dose resistance training (RT) maintenance interventions among older (ages 50–69), overweight and pre-diabetic adults.Design: Participants (N = 123) completed a three-month supervised RT initiation phase and were subsequently randomised (time 1) to high or low-dose six-month unsupervised RT maintenance interventions (time 2), followed by a six-month no-contact phase (time 3).Main Outcome Measures: Online measures of putative mediators and RT behaviour.Results: RT intervention condition (high vs. low dose) had significant effects on change from time 1 to time 2 in behavioural expectation, self-regulation and perceived satisfaction (f2 = .04–.08), but not outcome expectancies, RT strategies or behavioural intentions (f2 ≤ .02). Change in each of the putative mediators, except for outcome expectancies (f2 ≤ .02), had significant effects on RT behaviour at times 2 (f2 = .12–.27) and 3 (f2 = .23–.40). In a multiple mediation model, behavioural expectation (f2 = .11) and self-regulation (f2 = .06) mediated the effects of RT intervention condition on time 2 RT behaviour, whereas perceived satisfaction did not (f2 = .01). Self-regulation was a significant mediator of intervention effects on time 3 RT behaviour (f2 = .11), but behavioural expectation and perceived satisfaction were not (f2 = .04).Conclusions: Findings suggest that behavioural expectation and self-regulation are appropriate targets for RT maintenance interventions among at-risk older adults.