Maureen Lonergan

Interdisciplinary lifestyle intervention for weight management in a community population (HealthTrack study): Study design and baseline sample characteristics

BACKGROUND Integrating professional expertise in diet, exercise and behavioural support may provide more effective preventive health services but this needs testing. We describe the design and baseline results of a trial in the Illawarra region of New South Wales, Australia. METHODS The HealthTrack study is a 12 month randomised controlled trial testing effects of a novel interdisciplinary lifestyle intervention versus usual care. The study recruited overweight and obese adults 25-54 years resident in the Illawarra. Primary outcomes were weight, and secondary outcomes were disease risk factors (lipids, glucose, blood pressure), and behaviour (diet, activity, and psychological factors). Protocols, recruitment and baseline characteristics are reported. RESULTS Between May 2014 and April 2015, 377 participants were recruited and randomised. The median age (IQR) of the mostly female sample (74%) was 45 (37-51) years. The sample comprised obese (BMI 32 (29-35) kg/m(2)) well educated (79% post school qualifications) non-smokers (96%). A high proportion reported suffering from anxiety (26.8%) and depression (33.7%). Metabolic syndrome was identified in 34.9% of the sample. CONCLUSIONS The HealthTrack study sample was recruited to test the effectiveness of an interdisciplinary approach to preventive healthcare in self-identified overweight adults in the Illawarra region. The profile of participants gives some indication of those likely to use services similar to the trial design.

A Cross-Sectional Comparison of Health Literacy Deficits Among Patients With Chronic Kidney Disease

Inadequate health literacy in people with chronic kidney disease (CKD) is associated with poorer disease management and greater complications. There are limited data on the health literacy deficits of people with CKD. The aim of this study was to investigate the types and extent of health literacy deficits in patients with CKD using the multidimensional Health Literacy Management Scale (HeLMS) and to identify associations between patient characteristics and the domains of health literacy measured by the HeLMS. Invitations to participate were sent to patients with CKD attending the renal unit of a regional Australian hospital. These patients included predialysis, dialysis (peritoneal and hemodialysis), and kidney transplant patients. This study identified that inadequate health literacy—especially in the domains relating to attending to ones health needs, understanding health information, social support, and socioeconomic factors—was common. Male gender and education level were significantly associated with inadequate health literacy. The type and extent of health literacy deficits varied among CKD groups, and transplant patients had more deficits than other CKD patient groups. This study provides useful information for health professionals treating patients with CKD, especially with regard to the design of self-management interventions and health information.

A comparison of the extent and pattern of cognitive impairment among predialysis, dialysis and transplant patients: a cross sectional study from Australia.

The aim of this study was to compare the extent of cogntive impairment and the types of cognitive deficits in an Australian cohort of four patient groups with end stage kidney disease. Characteristics predicting the presence of cognitive impairment were also evaluated.

Effect of interdisciplinary care on weight loss: A randomised controlled trial

Objective To determine the effectiveness of a novel interdisciplinary treatment compared with usual care on weight loss in overweight and obese adult volunteers. Design Single blinded controlled trial. Participants randomly assigned to usual care (C, general guideline-based diet and exercise advice), intervention (I, interdisciplinary protocol) or intervention + a healthy food supplement (30 g walnuts/day) (IW). Setting Community based study, Illawarra region, south of Sydney, Australia. Participants Generally well volunteer adult residents, 25-54 years, body mass index (BMI) 25-40kg/m2 were eligible. At baseline 439 were assessed, 377 were randomised, 298 completed the 3-month intensive phase and 178 completed the 12-month follow-up. Interventions Treatment was provided at clinic visits intensively (0 months, 1 month, 2 months, 3 months) then quarterly to 12 months. Support phone calls were quarterly. All participants underwent blinded assessments for diet, exercise and psychological status. Primary and secondary measures The primary outcome was difference in weight loss between baseline and 12 months (clinically relevant target 5% loss). Secondary outcomes were changes in blood pressure, fasting blood glucose and lipids, and changes in diet, exercise and psychological parameters. Results At 12 months, differences in weight loss were identified (p<0.001). The I group lost more than controls at 3 months (91.11 (92.23,90.00), p<0.05) and the IW more than controls at 3 months (91.25 (92.35,90.15), p<0.05) and 6 months (92.20 (93.90,90.49), p<0.01). The proportion achieving 5% weight loss was significantly different at 3 months, 6 months and 9 months (p=0.04, p=0.03, p=0.03), due to fewer controls on target at 3 months, 6 months and 9 months and more IW participants at 6 months. Reductions in secondary outcomes (systolic blood pressure, blood glucose/lipid parameters and lifestyle measures) followed the pattern of weight loss. Conclusions An interdisciplinary intervention produced greater and more clinically significant and sustained weight loss compared with usual care. The intensive phase was sufficient to reach clinically relevant targets, but long-term management plans may be required. Trial registration number ANZCTRN 12614000581662; Post-results.

KHA-CARI Guideline: peritonitis treatment and prophylaxis.

Department of Nephrology, Royal Children’s Hospital, Melbourne, Victoria, Renal Unit, Royal Adelaide Hospital, Adelaide, South Australia, Renal Office, Concord Repatriation General Hospital, Renal Service, South Western Sydney Local Health District, Sydney, and Renal Department, The Wollongong Hospital, Wollongong, New South Wales, Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; and Department of Renal Medicine, Auckland City Hospital, Auckland, New Zealand

Randomised controlled trial to determine the efficacy and safety of prescribed water intake to prevent kidney failure due to autosomal dominant polycystic kidney disease (PREVENT-ADPKD)

Introduction Maintaining fluid intake sufficient to reduce arginine vasopressin (AVP) secretion has been hypothesised to slow kidney cyst growth in autosomal dominant polycystic kidney disease (ADPKD). However, evidence to support this as a clinical practice recommendation is of poor quality. The aim of the present study is to determine the long-term efficacy and safety of prescribed water intake to prevent the progression of height-adjusted total kidney volume (ht-TKV) in patients with chronic kidney disease (stages 1–3) due to ADPKD. Methods and analysis A multicentre, prospective, parallel-group, open-label, randomised controlled trial will be conducted. Patients with ADPKD (n=180; age ≤65 years, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2) will be randomised (1:1) to either the control (standard treatment+usual fluid intake) or intervention (standard treatment+prescribed fluid intake) group. Participants in the intervention arm will be prescribed an individualised daily fluid intake to reduce urine osmolality to ≤270 mOsmol/kg, and supported with structured clinic and telephonic dietetic review, self-monitoring of urine-specific gravity, short message service text reminders and internet-based tools. All participants will have 6-monthly follow-up visits, and ht-TKV will be measured by MRI at 0, 18 and 36 months. The primary end point is the annual rate of change in ht-TKV as determined by serial renal MRI in control vs intervention groups, from baseline to 3 years. The secondary end points are differences between the two groups in systemic AVP activity, renal disease (eGFR, blood pressure, renal pain), patient adherence, acceptability and safety. Ethics and dissemination The trial was approved by the Human Research Ethics Committee, Western Sydney Local Health District. The results will inform clinicians, patients and policy-makers regarding the long-term safety, efficacy and feasibility of prescribed fluid intake as an approach to reduce kidney cyst growth in patients with ADPKD. Trial registration number ANZCTR12614001216606.

Medication adherence in randomized controlled trials evaluating cardiovascular or mortality outcomes in dialysis patients: A systematic review

BackgroundMedication non-adherence is common among renal dialysis patients. High degrees of non-adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment effect. Cardio-protective pharmacological interventions have shown no consistent benefit in RCTs involving dialysis patients. Whether non-adherence contributes to this lack of efficacy is unknown. We aimed to investigate how medication adherence and drug discontinuation were assessed, reported and addressed in RCTs, evaluating cardiovascular or mortality outcomes in dialysis patients.MethodsElectronic database searches were performed in MEDLINE, EMBASE & Cochrane CENTRAL for RCTs published between 2005–2015, evaluating self-administered medications, in adult dialysis patients, which reported clinical cardiovascular or mortality endpoints, as primary or secondary outcomes. Study characteristics, outcomes, methods of measuring and reporting adherence, and data on study drug discontinuation were analyzed.ResultsOf the 642 RCTs in dialysis patients, 22 trials (12 placebo controlled), which included 19,322 patients, were eligible. The trialed pharmacological interventions included anti-hypertensives, phosphate binders, lipid-lowering therapy, cardio-vascular medications, homocysteine lowering therapy, fish oil and calcimimetics. Medication adherence was reported in five trials with a mean of 81% (range: 65–92%) in the intervention arm and 84.5% (range: 82–87%) in the control arm. All the trials that reported adherence yielded negative study outcomes for the intervention. Study-drug discontinuation was reported in 21 trials (mean 33.2%; 95% CI, 22.0 to 44.5, in intervention and 28.8%; 95% CI, 16.8 to 40.8, in control). Trials with more than 20% study drug discontinuation, more often yielded negative study outcomes (p = 0.018). Non-adherence was included as a contributor to drug discontinuation in some studies, but the causes of discontinuation were not reported consistently between studies, and non-adherence was listed under different categories, thereby potentiating the misclassification of adherence.ConclusionsReporting of medication adherence and study-drug discontinuation in RCTs investigating cardiovascular or mortality endpoints in dialysis patients are inconsistent, making it difficult to compare studies and evaluate their impact on outcomes. Recommendations for consistent reporting of non-adherence and causes of drug discontinuation in RCTs will therefore help to assess their impact on clinical outcomes.

Feasibility of a community‐based interdisciplinary lifestyle intervention trial on weight loss (the HealthTrack study)

Aim The aim of this study was to test the feasibility and acceptability of a novel interdisciplinary intervention on weight loss. Methods A 3-month parallel, blinded, randomised controlled trial compared the effects of an interdisciplinary model of care (individualised interdisciplinary advice delivered through dietitians) with control (general advice on diet and physical activity delivered by primary care nurses). The primary outcome was assessing feasibility and acceptability of the protocol, with secondary outcomes including body weight, clinical, dietary, physical activity and psychological variables. Results Twenty-four participants were randomised and 21 included in the final analysis. The recruitment rate was 42% (24/57) and the eligibility rate 83% (24/29). The withdrawal rate was low (13% overall) compared with similar trials. Attendance at study visits was higher in the intervention arm compared with control (100 vs 83%), which may be an artefact of the greater individualised treatment provided in the integrated model. Conclusions This study confirmed the feasibility and acceptability of the novel interdisciplinary lifestyle intervention within the region.

Treatment adherence in clinical trials evaluating cardiovascular or mortality outcomes in dialysis patients: a systematic review

021 CELL BASED THERAPY IN COMBINATION WITH SERELAXIN IS CRITICAL FOR PRESERVATION OF VASCULAR INTEGRITY VIA PROMOTION OF ANGIOGENESIS AND ANASTOMOSIS B HUUSKES1, A PINTO2, C SAMUEL3, S RICARDO1 1Department of Anatomy and Developmental Biology, Monash University, Clayton, Victoria; 2Australian Regenerative Medicine Institute, Monash University, Clayton, Victoria; 3Department of Pharmacology, Monash University, Clayton, Victoria

Efficacy of nutrition as medication in malnourished hospitalised patients is strongly influenced by environmental factors

Aim To evaluate the use of Nutrition as Medication (NAM) as a dietary intervention strategy in a sample of malnourished renal and geriatric hospital inpatients. Methods In the study period of 1 July to 30 August 2009, patients admitted to the acute renal or geriatric wards of a large general hospital and assessed as malnourished or at risk of malnutrition and suitable to commence NAM were eligible for inclusion in this pilot clinical cohort study. Medication charts of the study patients were audited and opportunistic observations of patients receiving NAM were conducted. Comparisons of receival and refusal rates of NAM between chart audits and observations were made. Environmental influences on administration, delivery and consumption were noted. Results Eighteen patients were included in the study. Audits of their medication charts indicated 943 doses of NAM were prescribed in the study period. The receival rate of NAM was 66.4% and refusal rate was 8.9%. Forty-eight incident observations of the NAM process were conducted noting a receival rate was 58.3% and refusal rate of 3.6%. Environmental factors such as adequate supplies and location of NAM stock influenced the receival rate of NAM. Conclusions In the present study, receival of NAM by renal and geriatric inpatients was suboptimal. The strategy was strongly influenced by environmental factors such as nurse administration of NAM. However, when NAM was received as prescribed, refusal was rare. Further exploration is warranted of NAM receival and consumption in other malnourished groups and of the environmental factors influencing NAM delivery.