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Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

ABSTRACT: INTRODUCTION:The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d'Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. METHODS AND ANALYSIS:A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. ETHICS AND DISSEMINATION:The Research Ethics Committee of the CIUSSS Estrie - CHUS has approved the study (MP-31-2018-2424). An informed consent form will be read and signed by all study participants. Findings will be published and presented at conferences. TRIAL REGISTRATION NUMBER:NCT03161860; Pre-results.

SUBMITTER: Levasseur M

PROVIDER: S-EPMC5884338 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

Levasseur Mélanie M Dubois Marie-France MF Filliatrault Johanne J Vasiliadis Helen-Maria HM Lacasse-Bédard Joanie J Tourigny André A Levert Marie-Josée MJ Gabaude Catherine C Lefebvre Hélène H Berger Valérie V Eymard Chantal C

BMJ open 20180331 3

<h4>Introduction</h4>The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the <i>Accompagnement-citoyen Personnalisé d'Intégration Communautaire</i> (APIC), a ...[more]

PMID: 29605819

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Project description:Objective: Given that positive psychological capital motivates citizens to actively participate in social affairs, this study aims to provide insight into food safety risk management in China by empirically determining which individual characteristics are associated with positive psychological capital for actively participating in social co-governance. Methods: A questionnaire-based survey was undertaken between December 5 and 10, 2020. The study participants were residents of Wuxi in China over the age of 18 years. A validated and pretested questionnaires was used to elicit responses with the participants. Student's t-test and one-way analysis of variance were performed to determine which individual characteristics are significantly correlated with the psychological capital of citizens who participate in co-governance. Post-hoc multiple comparisons were performed for each individual characteristic with a significant correlation to determine which categories of these characteristics yielded the significant differences. Study data were analyzed using IBM SPSS Statistics 24.0. Results: A total of 752 completed responses were received. Most respondents were females (52.39%), aged 26-45 (66.09%), married (70.48%), company employees (44.28%), and in good health (89.76%). Most had a household size of 3 (55.98%), a bachelor's degree (40.96%), a personal annual income of more than 100,000 yuan (26.46%), and no children aged under 18 (50.27%) or pregnant women (93.22%) in their households. Data analysis indicated that education, income, and health status significantly associate with the psychological capital of citizens to participate in co-governance. Citizens with high education, high income, and good health status have higher psychological capital to participate in co-governance. Conclusion: The present study suggested citizens are likely to actively participate in food safety social co-governance only when they have at least one of the following three characteristics: (1) higher than average income in their city of residence; (2) a bachelor's degree or higher education; or (3) good health. Therefore, motivating citizens to participate in co-governance is a long-term process in China. The fundamental strategy is to increase the income of citizens, especially among low-income groups, promote education to improve the food safety literacy of the public, and improve sanitation and public health.

Project description:ObjectiveTo assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy.DesignPragmatic, multicentre, randomised controlled trial (ARTISAN).Setting and participantsTrauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management.InterventionsOne session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses.Main outcome measuresThe primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications.Results482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05).ConclusionsAn additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy.Trial registrationCurrent Controlled Trials ISRCTN63184243.

Project description:BackgroundData monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional 'good clinical practice data monitoring' with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings.MethodsThe present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation.ResultsThe first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity.DiscussionWe present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data.

Project description:BACKGROUND:Peer support is an established intervention involving a person recovering from mental illness supporting others with mental illness. Peer support is an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at multiple levels, including service user outcomes (psychosocial and clinical), peer support worker outcomes (work role and empowerment), service outcomes (cost-effectiveness and return on investment), and implementation outcomes (adoption, sustainability and organisational change). METHODS:UPSIDES-RCT is a pragmatic, parallel-group, multicentre, randomised controlled trial assessing the effectiveness of using peer support in developing empowering mental health services (UPSIDES) at four measurement points over 1 year (baseline, 4-, 8- and 12-month follow-up), with embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, UK, Israel, India, Uganda and Tanzania). The primary outcome is social inclusion of service users with severe mental illness (N?=?558; N?=?93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (using the Empowerment Scale), hope (using the HOPE scale), recovery (using Stages of Recovery) and health and social functioning (using the Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect and the implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers and policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support. DISCUSSION:The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention in different cultural, organisational and resource settings. By actively involving and empowering service users, UPSIDES will move mental health systems toward a recovery orientation, emphasising user-centredness, community participation and the realisation of mental health as a human right. TRIAL REGISTRATION:ISRCTN, ISRCTN26008944. Registered on 30 October 2019.

Dataset Information

Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

Publications

Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

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