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Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

ABSTRACT: BACKGROUND:Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. METHODS:This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample size will allow us to detect a 20 % difference in WHODAS 2.0 scores between treatment arms with 85 % power. Secondary outcomes include change in symptom severity, economic activity, physical restraint, discrimination and caregiver burden. DISCUSSION:This is the first trial of community-based rehabilitation for schizophrenia and will determine, as a proof of concept, the added value of community-based rehabilitation compared to facility-based care alone in a low-income country with scarce mental health resources. TRIAL REGISTRATION:Clinical Trials.gov Identifier NCT02160249 . Registered on 3 June 2014.

SUBMITTER: Asher L

PROVIDER: S-EPMC4919867 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

Asher Laura L De Silva Mary M Hanlon Charlotte C Weiss Helen A HA Birhane Rahel R Ejigu Dawit A DA Medhin Girmay G Patel Vikram V Fekadu Abebaw A

Trials 20160624 1

<h4>Background</h4>Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper ...[more]

PMID: 27342215

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Project description:BackgroundCommunity-based rehabilitation (CBR) is recommended to address the social and clinical needs of people with schizophrenia in resource-poor settings. We evaluated the effectiveness of CBR at reducing disability at 12 months in people with schizophrenia who had disabling illness after having had the opportunity to access facility-based care for 6 months METHODS: This cluster-randomised controlled trial was conducted in a rural district of Ethiopia. Eligible clusters were subdistricts in Sodo district that had not participated in the pilot study. Available subdistricts were randomised (in a 1:1 ratio) to either the intervention group (CBR plus facility-based care) or to the control group (facility-based care alone). An optimisation procedure (accounting for the subdistrict mean WHO Disability Assessment Schedule (WHODAS) score and the potential number of participants per subdistrict) was applied for each of the eight health facilities in the district. An independent statistician, masked to the intervention or control label, used a computer programme to randomly choose the allocation sequence from the set of optimal ones. We recruited adults with disabling illness as a result of schizophrenia. The subdistricts were eligible for inclusion if they included participants that met the eligibility criteria. Researchers recruiting and assessing participants were masked to allocation status. Facility-based care was a task-shared model of mental health care integrated within primary care. CBR was delivered by lay workers over a 12-month period, comprising of home visits (psychoeducation, adherence support, family intervention, and crisis management) and community mobilisation. The primary outcome was disability, measured with the proxy-rated 36-item WHODAS score at 12 months. The subdistricts that had primary outcome data available were included in the primary analysis. This study is registered with ClinicalTrials.gov, NCT02160249.FindingsEnrolment took place between Sept 16, 2015 and Mar 11, 2016. 54 subdistricts were randomised (27 to the CBR plus facility-based care group and 27 to the facility-based care group). After exclusion of subdistricts without eligible participants, we enrolled 79 participants (66% men and 34% women) from 24 subdistricts assigned to CBR plus facility-based care and 87 participants (59% men and 41% women) from 24 subdistricts assigned to facility-based care only. The primary analysis included 149 (90%) participants in 46 subdistricts (73 participants in 22 subdistricts in the CBR plus facility-based care group and 76 participants in 24 subdistricts in the facility-based care group). At 12 months, the mean WHODAS scores were 46·1 (SD 23·3) in the facility-based care group and 40·6 (22·5) in the CBR plus facility-based care group, indicating a favourable intervention effect (adjusted mean difference -8·13 [95% CI -15·85 to -0·40]; p=0·039; effect size 0·35). Four (5%) CBR plus facility-based care group participants and nine (10%) facility-based care group participants had one or more serious adverse events (death, suicide attempt, and hospitalisation).InterpretationCBR delivered by lay workers combined with task-shared facility-based care, was effective in reducing disability among people with schizophrenia. The RISE study CBR model is particularly relevant to low-income countries with few mental health specialists.FundingWellcome Trust.

Project description:BackgroundCommunity-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia.MethodsThis mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members.ResultsThe RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale.ConclusionIn low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness.

Project description:BackgroundCommunity-based rehabilitation (CBR) is a multi-sectoral strategy to improve the functioning and quality of life of people with disabilities. The RISE (Rehabilitation Intervention for people with Schizophrenia in Ethiopia) trial will evaluate the effectiveness of CBR for people with schizophrenia in Ethiopia. Nevertheless, the components of CBR that are both feasible and likely to prove effective in low and middle-income countries such as Ethiopia are unclear.MethodsIn this study intervention development work was undertaken to design a CBR intervention that is acceptable and feasible in the local context. The development work consisted of five phases. 1: Identify potential components of CBR for schizophrenia, 2: Situational analysis, 3: Determine feasibility of CBR (Theory of Change workshops with experts and local stakeholders), 4: Determine acceptability of CBR (16 in-depth interviews and five focus group discussions with people with schizophrenia, caregivers, health workers and community leaders) and 5: Synthesise results to finalise intervention. A Theory of Change map was constructed showing the causal pathway for how we expect CBR to achieve its impact.ResultsPeople with schizophrenia in rural Ethiopia experience family conflict, difficulty participating in work and community life, and stigma. Stakeholders perceived CBR to be acceptable and useful to address these problems. The focus of CBR will be on the individual developing the skills and confidence to perform their previous or desired roles and activities. To ensure feasibility, non-health professionals will be trained to deliver CBR and provide supervision, rather than mental health specialists. Novel components of CBR for schizophrenia included family intervention and dealing with distressing symptoms. Microfinance was excluded due to concerns about stress and exploitation. Community mobilisation was viewed as essential to ensure the effectiveness and sustainability of CBR.ConclusionExtensive formative research using a variety of methods has enabled the design of a culturally appropriate CBR intervention for people with schizophrenia that is acceptable and feasible.

Project description:BackgroundThere are gaps in our understanding of how non-specialists, such as lay health workers, can achieve core competencies to deliver psychosocial interventions in low- and middle-income countries.MethodsWe conducted a 12-month mixed-methods study alongside the Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE) pilot study. We rated a total of 30 role-plays and 55 clinical encounters of ten community-based rehabilitation (CBR) lay workers using an Ethiopian adaptation of the ENhancing Assessment of Common Therapeutic factors (ENACT) structured observational rating scale. To explore factors influencing competence, six focus group discussions and four in-depth interviews were conducted with 11 CBR workers and two supervisors at three time-points. We conducted a thematic analysis and triangulated the qualitative and quantitative data.ResultsThere were improvements in CBR worker competence throughout the training and 12-month pilot study. Therapeutic alliance competencies (e.g., empathy) saw the earliest improvements. Competencies in personal factors (e.g., substance use) and external factors (e.g., assessing social networks) were initially rated lower, but scores improved during the pilot. Problem-solving and giving advice competencies saw the least improvements overall. Multimodal training, including role-plays, field work and group discussions, contributed to early development of competence. Initial stigma towards CBR participants was reduced through contact. Over time CBR workers occupied dual roles of expert and close friend for the people with schizophrenia in the programme. Competence was sustained through peer supervision, which also supported wellbeing. More intensive specialist supervision was needed.ConclusionIt is possible to equip lay health workers with the core competencies to deliver a psychosocial intervention for people with schizophrenia in a low-income setting. A prolonged period of work experience is needed to develop advanced skills such as problem-solving. A structured intervention with clear protocols, combined with peer supervision to support wellbeing, is recommended for good quality intervention delivery. Repeated ENACT assessments can feasibly and successfully be used to identify areas needing improvement and to guide on-going training and supervision.

Project description:BackgroundObservational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care.MethodsWe did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013.Findings187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference -3.75, 95% CI -7.92 to 0.42; p=0.08; IDEAS -0.95, -1.68 to -0.23; p=0.01). However, no difference was shown in the proportion of participants who had a reduction of more than 20% in overall symptoms (PANSS 85 [51%] in the intervention group vs 44 [51%] in the control group; p=0.89; IDEAS 75 [48%] vs 28 [35%]). We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site (-9.29, -15.41 to -3.17; p=0.003). Two patients (one in each group) died by suicide during the study, and two patients died because of complications of a road traffic accident and pre-existing cardiac disease. 18 (73%) patients (17 in the intervention group) were admitted to hospital during the course of the trial, of whom seven were admitted because of physical health problems, such as acute gastritis and vomiting, road accident, high fever, or cardiovascular disease.InterpretationThe collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care, especially for reducing disability and symptoms of psychosis. Our results show that the study intervention is best implemented as an initial service in settings where services are scarce, for example in rural areas.FundingWellcome Trust.

Project description:Introduction Excessive alcohol consumption is responsible for considerable harm from chronic disease and injury. Within most developed countries, members of sporting clubs consume alcohol at levels above that of communities generally. Despite the potential benefits of interventions to address alcohol consumption in sporting clubs, there have been no randomised controlled trials to test the effectiveness of these interventions. The aim of this study is to examine the effectiveness of a comprehensive accreditation intervention with community football clubs (Rugby League, Rugby Union, soccer/association football and Australian Rules football) in reducing excessive alcohol consumption by club members. Methods and analysis The study will be conducted in New South Wales, Australia, and employ a cluster randomised controlled trial design. Half of the football clubs recruited to the trial will be randomised to receive an intervention implemented over two and a half winter sporting seasons. The intervention is based on social ecology theory and is comprehensive in nature, containing multiple elements designed to decrease the supply of alcohol to intoxicated members, cease the provision of cheap and free alcohol, increase the availability and cost-attractiveness of non-alcoholic and low-alcoholic beverages, remove high alcohol drinks and cease drinking games. The intervention utilises a three-tiered accreditation framework designed to motivate intervention implementation. Football clubs in the control group will receive printed materials on topics unrelated to alcohol. Outcome data will be collected pre- and postintervention through cross-sectional telephone surveys of club members. The primary outcome measure will be alcohol consumption by club members at the club, assessed using a graduated frequency index and a seven day diary. Ethics and dissemination The study was approved by The University of Newcastle Human Research Ethics Committee (reference: H-2008-0432). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12609000224224.

Project description:In 2011, more than half of the patients with stroke in Australian hospitals were not assessed for the need for rehabilitation. Further, there were no recommended criteria to guide rehabilitation assessment decisions. Subsequently, a decision-making tool called the Assessment for Rehabilitation Tool (ART) was developed. The ART was designed to assist Australian hospital clinicians to identify the rehabilitation needs of patients with stroke using evidence-based criteria. The ART was released and made freely available for use in 2012. This study evaluated the effectiveness of an education-only intervention (1 onsite education session and distribution of the ART) and a multifaceted intervention (2 or more onsite education sessions, distribution of the ART, audit and feedback, barrier identification, site-specific strategy development, promotion of interdisciplinary teamwork, opinion leaders and reminders) for improving assessments of rehabilitation needs after stroke.Ten hospitals in 2 states of Australia were randomly assigned to an education-only or a multifaceted intervention. Medical records were audited by assessors blinded to group allocation before and after the implementation period. Difference in the proportion of patients assessed for rehabilitation before and after the intervention was analysed using mixed-effects logistic regression analysis, with time period as the dependent variable, an interaction between intervention type and time included to test for differences between the interventions, and hospital included as the random effect to account for patient clustering.Data from 586 patients (284 pre-intervention; 302 post-intervention; age 76 years, 59 % male) showed that the multifaceted intervention was not more effective than education-only in improving the proportion of patients whose rehabilitation needs were assessed (reference category education-only; odds ratio 1.29, 95 % confidence interval 0.63-2.67, p = 0.483). Post-intervention, the odds of a patient's rehabilitation needs being assessed was 3.69 times greater than pre-intervention (95 % confidence interval 2.57-5.30, p < 0.001). Evidence-based criteria were not consistently used when patients were deemed to have no rehabilitation needs.A multifaceted intervention was not more effective than education-only in improving the assessment of rehabilitation needs of patients with stroke. Further interventions are required to ensure that all patients are assessed for the need for rehabilitation using evidence-based criteria.ANZCTR (Australian New Zealand Clinical Trials Registry), ACTRN12616000340437.

Project description:BackgroundPulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people's homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial.MethodsA mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up.DiscussionThe process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people.Trial registrationClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

Dataset Information

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

Publications

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

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