Evaluating the Efficacy of the “Support for Life” Program for People with Dementia and Their Families and Carers’ to Enable Them to Live Well: A Protocol for a Cluster Stepped Wedge Randomized Controlled Trial

Introduction Assistance provided to support people living with dementia and carers is highly valued by them. However, current support systems in Australia are disjointed, inaccessible to all, poorly coordinated, and focus on dysfunction rather than ability. Support workers for people with dementia are in short supply, and there is little consistency in their roles. To address this large service gap and unmet need, we have developed an evidence-based optimized model of holistic support for people with dementia and their carers and families. This article describes the “Support for Life” model intervention. Methods A stepped wedge cluster randomized controlled trial will be conducted over 3 years across three Australian states. One hundred participants with dementia and/or their carers/family members will be randomly selected from community health center client lists in each state to receive either the dementia “Support for Life” intervention (Group A) or routine care (Group B). Group A participants will have access to the intervention from year 1. Group B participants will continue to receive usual care and will not be denied information on dementia or dementia services in year 1. In year 2, Group B participants will have access to the intervention. A highly trained expert dementia support worker will provide the “Support for Life” intervention, which is a flexible, individually tailored, holistic support that is relationship-centered, focused on enablement as opposed to dysfunction, and facilitate participants’ continued engagement in their community and the workforce. Additionally, dementia education, information resources, advocacy, and practical support to navigate and access dementia services and health care will be provided. The mode of support will include face to face, telephone, and internet interaction on an “as needed basis” for 12 months. The primary hypothesis is that the intervention will improve the quality of life of people with dementia and the health and well-being of carers/family through facilitating the continuation and enhancement of regular daily activities. Secondary hypotheses will examine other health and service usage outcomes. The outputs will also include a health economic analysis to investigate the costs (and savings) of any associated reduction in unnecessary health services use and delay in accessing permanent residential aged care

Effect of a Health Coach Intervention for the Management of Individuals With Type 2 Diabetes Mellitus in China: A Pragmatic Cluster Randomized Controlled Trial

Aim: To determine the effect of a health coach intervention for the management of glycemic control, as well as physiological, psychological and self-care outcomes of patients with type 2 diabetes mellitus (T2DM), compared with usual care.Methods: This pragmatic cluster RCT was conducted in the Fengtai district of Beijing from August 2011 to December 2013. Forty-one community health stations (CHSs) were cluster randomized (stratified geographically, 1:1 ratio) and eligible, randomly selected T2DM patients were sequentially contacted by CHSs. Control participants received usual care according to the Chinese Guideline for Diabetes Prevention and Management. Intervention participants received 18-months of health coaching based on principles of Motivational Interviewing (MI) plus usual care. Medical and pathology fees were waived for both groups. Outcome assessment was performed at baseline, 6, 12, and 18-months. The primary outcome was glycated hemoglobin (HbA1c); secondary outcomes encompassed a suite of physiological, psychological and self-care measures.Results: No differential treatment effect was found at 18-months for HbA1c (adj. difference −0.07, 95% CI −0.53 to 0.39, p = 0.769) or any specified secondary outcomes. Interestingly, both groups displayed a statistically and clinically significant within-group improvement of the same magnitude at 18-months for HbA1c (intervention: mean change −3.65, 95% CI −3.92 to −3.37; control: mean change −3.38, 95% CI −3.67 to −3.08).Conclusions: The lack of differential treatment effects observed indicate that it may be premature to recommend the routine delivery of health coach interventions based on MI principles for the management of T2DM in China. However, the large, comparable within-group improvement in mean HbA1c promotes the establishment of free, regular clinical health assessments for individuals with T2DM in China.Trial Registration: ISRCTN registry - ISRCTN01010526 (https://doi.org/10.1186/ISRCTN01010526

The PROblem Gambling RESearch Study (PROGRESS) research protocol: a pragmatic randomised controlled trial of psychological interventions for problem gambling.

INTRODUCTION: International prevalence rates for problem gambling are estimated at 2.3%. Problem gambling is a serious global public health concern due to adverse personal and social consequences. Previous research evaluating the effectiveness of psychological interventions for the treatment of problem gambling has been compromised by methodological limitations, including small sample sizes and the use of waitlist control groups. This article describes the study protocol for a pragmatic randomised controlled trial (RCT) evaluating the effectiveness of cognitive-behavioural therapy (CBT), behaviour therapy (BT), motivational interviewing (MI) against a non-directive supportive therapy (NDST) control, in treating problem gambling. METHODS AND ANALYSIS: This study was a mixed-methods design, with a parallel group, pragmatic RCT as the primary component, and embedded qualitative studies conducted alongside. A total of 297 participants were recruited from the community in Victoria, Australia. Individuals aged 18 years and over, could communicate in English and wished to receive treatment for a gambling problem were eligible. Participants were randomly allocated in to 1 of the 4 psychological interventions: CBT, BT, MI and NDST. Repeated measures were conducted at pretreatment and post-treatment, and 6 and 12 months post-treatment. The statistical analysis will use an intention-to-treat approach. Multilevel mixed modelling will be used to examine changes in the primary outcome measures: gambling symptom severity, using the Gambling Symptom Assessment Scale, and gambling behaviours (frequency, time and expenditure). Secondary outcomes are depression, anxiety, stress and alcohol use. Individual semistructured qualitative interviews were conducted at pretreatment and post-treatment and 12 months post-treatment for a subset of participants (n=66). ETHICS AND DISSEMINATION: This study was approved by the Victorian Department of Justice, Monash University and the University of Melbourne Human Research Ethics Committees. Findings will be reported in a government report, peer-reviewed publications and conference presentations

Psychological interventions for the management of glycemic and psychological outcomes of Type 2 Diabetes Mellitus in China: a systematic review and meta-analyses of randomized controlled trials

INTRODUCTION: China has the largest number of type 2 diabetes mellitus (T2DM) cases globally, and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances, and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM-related outcomes; however, these reviews have predominantly included studies conducted within English-speaking countries and have not determined the efficacy of the varying types of psychological interventions. As such, this paper aims to synthesize evidence and quantify the efficacy of psychological therapies for the management of glycemic and psychological outcomes of T2DM in China, relative to control conditions. METHODS: A systematic search (MEDLINE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Wangfang Data) for all years to December 2014 identified all available literature. Eligibility criteria included: peer-reviewed journal articles, randomized controlled trials (RCTs) assessing the efficacy of a psychological therapy for the management of T2DM, adult participants (≥18 years) diagnosed with T2DM or non-insulin-dependent diabetes mellitus, and Chinese speaking participants only (in mainland China). Outcome measures were glycated hemoglobin, blood glucose concentration, depression, anxiety, and quality of life. Effect sizes were pooled using a random effects model. Negative effect sizes corresponded to positive outcomes favoring the intervention. RESULTS: Forty-five RCTs were eligible for the meta-analyses. Cognitive behavioral therapy (CBT) and motivational interviewing (MI) were more effective than the control condition in the reduction of glycated hemoglobin [CBT: -0.97 (95% CI -1.37 to -0.57); MI: -0.71 (95% CI -1.00 to -0.43)]. CBT and client-centered therapy (CCT) were also associated with reductions in depression and blood glucose concentration, and CBT was associated with reductions in anxiety. CONCLUSION: Psychological interventions, namely, CBT, MI, and CCT are effective in improving certain T2DM-related outcomes in China. Considerable levels of heterogeneity and unclear risk of bias associated with most included RCTs suggest caution when interpreting results. In China, where the burden of T2DM is increasing significantly, psychological interventions may provide promising approaches to assist in the management of T2DM to delay the progression of T2DM related outcomes

A systematic review of studies with a representative sample of refugees and asylum seekers living in the community for participation in mental health research.

BACKGROUND: The aim was to review the literature to identify the most effective methods for creating a representative sample of refugee and asylum seeker groups living in the community to participate in health and mental health survey research. METHODS: A systematic search of academic and grey literature was conducted for relevant literature with 'hidden' groups published between January 1995 and January 2016. The main search used Medline, PsycINFO, EMBASE, CINAHL and SCOPUS electronic databases. Hidden groups were defined as refugees, asylum seekers, stateless persons or hard/difficult to reach populations. A supplementary grey literature search was conducted. Identified articles were rated according to a created graded system of 'level of evidence for a community representative sample' based on key study factors that indicated possible sources of selection bias. Articles were included if they were assessed as having medium or higher evidence for a representative sample. All full-text papers that met the eligibility criteria were examined in detail and relevant data extracted. RESULTS: The searches identified a total of 20 publications for inclusion: 16 peer-reviewed publications and four highly relevant reports. Seventeen studies had sampled refugee and asylum seekers and three other hidden groups. The main search identified 12 (60.0%) and the grey search identified another eight (40.0%) articles. All 20 described sampling techniques for accessing hidden groups for participation in health-related research. Key design considerations were: an a priori aim to recruit a representative sample; a reliable sampling frame; recording of response rates; implementation of long recruitment periods; using multiple non-probability sampling methods; and, if possible, including a probability sampling component. Online social networking sites were used by one study. Engagement with the refugee and asylum seeker group was universally endorsed in the literature as necessary and a variety of additional efforts to do this were reported. CONCLUSIONS: The strategies for increasing the likelihood of a representative sample of this hidden group were identified and will assist researchers when doing future research with refugee groups. These findings encourage more rigorous reporting of future studies so that the representativeness of samples of these groups in research can be more readily assessed

The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial a training intervention for community mental health teams in recovery-oriented practice

Background: Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes. Methods: The mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18-75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder diagnosis (44 at baseline, step 1; 44 at step 1, step 2). cRCT data will be analyzed using multilevel mixed-effects modelling to account for clustering and some repeated measures, supplemented by thematic analysis of qualitative interview data. The process evaluation will draw on qualitative, quantitative and documentary data. Discussion: Findings will provide an evidence-base for the continued transformation of Australian mental health service frameworks toward recovery