- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02442193
Individual Placement and Support for Patients With Offending Histories (IPSOH)
Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a feasibility trial which aims to assess the feasibility of conducting a full Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.
Given that IPS is a complex intervention, the design of this study has drawn from the principles set out in the UK Medical Research Council (MRC) Guidance on developing and evaluating complex interventions by defining three major research strands in order to achieve the specific objectives of the study as follows:
A. Implementation of IPS in community forensic services: The specific objective of this strand is to embed the IPS model in the community forensic services in which the feasibility study will be carried out (aided by an IPS Expert), by bringing an employment specialist into clinical teams, raising awareness about IPS within the organization, forming links with IPS services in the area and developing links with employers, as well as conducting IPS fidelity reviews.
B. Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including:
- Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.
- The feasibility of randomization, recruitment and retention rates to the IPS and controls;
- The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores.
C. Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods:
- Qualitative interviews with staff to identify the structural, legal, organizational and individual-level to barriers and facilitators to implementation of IPS in community forensic services.
- Fidelity Reviews to assess the extent to which the services follow the principles of IPS and to assess how well the employment specialist functions within the community forensic services.
- Qualitative interviews with patients assigned to IPS in order to assess their general views of IPS, benefits from participating, disadvantages from or dislikes about participating and barriers and facilitators to implementation.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Nottingham, Reino Unido
- Nottinghamshire NHS Foundation Trust
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults over the age of 18 years
- Patients (females and males) on the caseload of the community forensic services
Exclusion Criteria:
- Patients unable to provide informed consent
- Patients not eligible to work in the UK
- Patients currently in open employment
- Patients who do not wish to work
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Individual Placement and Support
|
Individual Placement and Support is a form of supported employment.
|
|
Sem intervenção: Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Open Employment: Proportion of people in open employment
Prazo: 12 Months
|
Proportion of people in open employment at 12 month follow-up
|
12 Months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of hours worked
Prazo: 12 Months
|
Number of hours worked at 12 month follow-up
|
12 Months
|
|
Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
Prazo: Baseline, 6 and 12 Months
|
Measured using the Brief Psychiatric Rating Scale (BPRS)
|
Baseline, 6 and 12 Months
|
|
Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
Prazo: Baseline, 6 and 12 Months
|
Measured using the Social Functioning Questionnaire (SFQ)
|
Baseline, 6 and 12 Months
|
|
Self-Esteem as measured using the Rosenberg's Self Esteem Scale
Prazo: Baseline, 6 and 12 Months
|
Measured using the Rosenberg's Self Esteem Scale
|
Baseline, 6 and 12 Months
|
|
Work Limitations as measured using the Work Limitation Questionnaire
Prazo: Baseline, 6 and 12 Months
|
Measured using the Work Limitation Questionnaire
|
Baseline, 6 and 12 Months
|
|
Quality of life as measured using SF-12v2
Prazo: Baseline, 6 and 12 Months
|
Health-related quality of life as measured using SF-12v2
|
Baseline, 6 and 12 Months
|
|
Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
Prazo: Baseline, 6 and 12 Months
|
Measured using the Client Service Receipt Inventory (CSRI)
|
Baseline, 6 and 12 Months
|
|
Re-offending rates
Prazo: Baseline and 18 Months
|
Re-offending rates
|
Baseline and 18 Months
|
|
Number of days in open employment
Prazo: 12 months
|
Number of days in open employment at 12 months
|
12 months
|
|
Quality of life as measured using the EQ5-D
Prazo: Baseline, 6 and 12 months
|
Health-related quality of life as measured using the EQ5-D
|
Baseline, 6 and 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Najat R Khalifa, DM, Nottinghamshire Healthcare Nhs Trust
Publicações e links úteis
Publicações Gerais
- Khalifa N, Talbot E, Schneider J, Walker DM, Bates P, Bird Y, Davies D, Brookes C, Hall J, Vollm B. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol. BMJ Open. 2016 Jul 22;6(7):e012710. doi: 10.1136/bmjopen-2016-012710.
- Khalifa N, Talbot E, Barber S, Schneider J, Bird Y, Attfield J, Bates P, Walker DM, Vollm B. A Feasibility Cluster Randomized Controlled Trial of Individual Placement and Support (IPS) for Patients With Offending Histories. Front Psychiatry. 2020 Jan 13;10:952. doi: 10.3389/fpsyt.2019.00952. eCollection 2019.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- KHALIFA/020415
- PB-PG-1013-32093 (Número de outro subsídio/financiamento: NIHR - Research for Patient Benefit (RfPB))
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Tratamento como de costume
-
Babes-Bolyai UniversityAtivo, não recrutando
-
Dan RamdathHealth Canada; Advance Foods and Materials Network; University of Lethbridge; University...ConcluídoO foco do estudo é definir a microbiota intestinal usual após a alimentação prebióticaCanadá
-
Institute of Cancer Research, United KingdomNational Cancer Institute (NCI); ECOG-ACRIN Cancer Research GroupRecrutamentoCarcinoma de Células Escamosas do Pênis, Tipo UsualEstados Unidos, Reino Unido
-
Maruho Co., Ltd.ConcluídoNeoplasia Intraepitelial Vulval Tipo Usual (uVIN)Holanda
-
Frantz Viral Therapeutics, LLCThe Cleveland ClinicRecrutamentoDoenças vulvares | Infecção por HPV | Vulvar HSIL | Neoplasia Intraepitelial de Alto Grau | Doença de HPV | Displasia Pré-Cancerosa | Vin II | Vin III | VIN, tipo usual | VIN 2 do tipo usual | VIN 3 do tipo usual | VIN Grau 2 | VIN Grau 3Estados Unidos
-
Maastricht UniversityUniversité Libre de BruxellesConcluídoFibrose Pulmonar Idiopática | Doença Pulmonar Intersticial | Pneumonia Intersticial UsualHolanda
-
Turkish Thoracic SocietyRescindidoFibrose Pulmonar Idiopática | Pneumonia Intersticial UsualPeru
-
IRCCS Azienda Ospedaliera Universitaria San Martino...ConcluídoPneumonia Intersticial Usual | Pneumonia intersticial inespecífica
-
Cosmos Rx, IncNational Heart, Lung, and Blood Institute (NHLBI); Sentara Norfolk General HospitalAinda não está recrutandoHipertensão pulmonar | Pulmão Sarcoidose | Pneumonia Intersticial Usual | Fibrose Pulmonar Idiopática (FPI)Estados Unidos
-
Gloucestershire Hospitals NHS Foundation TrustSuspensoLíquen Escleroso | Carcinoma de células escamosas | Pele Vulvar Normal | Displasia de alto grau - tipo usual ('VIN 2-3') | Displasia de Alto Grau - Tipo Diferenciado ('VIN 2-3') | Hiperplasia Epitelial Sem Atipia | Atipia Sem Outra Especificação/ Displasia de Baixo Grau ('VIN 1') | Doença de Paget...Reino Unido
Ensaios clínicos em Individual Placement and Support
-
Psychiatric Research Unit, Region Zealand, DenmarkRetiradoInternação Psiquiátrica