Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN (Shared-Care)
29 de abril de 2022 atualizado por: Ottawa Hospital Research Institute
The study is evaluating an intervention consisting of a five week online mindfulness program for patients being referred to the Pain Clinic and triaged to eConsult.
A pain specialist will be in contact with the patient's family physician to confirm it's appropriate and then a therapist will initiate contact with the patient to assess eligibility.
The therapist will be a registered health professional with experience with patients with chronic health problems and will be supporting the online program where the participant will have communication access to them.
Questionnaires will be sent at three time points to assess changes.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
There are currently many patients waiting to be seen at The Ottawa Hospital Pain Clinic (TOHPC). However, many patients with chronic pain (CP) have exhausted medical options or could be served in the community with appropriate support for them and their family physicians (FPs). eConsult is a secure web-based platform that allows TOHPC physicians to provide pain management advice within seven days within the Champlain Local Health Integration Network (LHIN).
In order to provide enhanced care to patients and improve the uptake of eConsult for CP, the investigators have developed a shared care model for CP in the Champlain LHIN. This program combines the use of eConsult for FPs and a 5-week self-directed online CP management program with therapist support available as needed.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
240
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Patricia Poulin, PhD C. Psych
- Número de telefone: 73903 6137378899
- E-mail: ppoulin@toh.ca
Locais de estudo
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Ontario
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Ottawa, Ontario, Canadá, K1H8L6
- Ottawa Hospital Research Institute
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- aged 18-years or older
- ability to understand oral and written English
- report chronic pain (≥3months)
Exclusion Criteria:
- refusal or inability to provide informed consent
- severe, unstable or untreated psychiatric conditions (ex. severe depression, psychosis, bipolar, etc.)
- does not have access to the internet or electronic device capable of watching videos
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Online chronic pain management program
There is only one arm.
Those who consent to participate in the study and take the online self-directed chronic pain management program with therapist support.
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With the support of a study therapist, the participant will be enrolled in a 5 week self-directed pain management program.
The study therapist is a registered health professional.
The program will consist of 5 weeks of mindfulness training.
The mindfulness training focuses on the basics of mindfulness-based interventions including body, emotions, sensations, thoughts, compassion, pain and stress management.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10.
The higher the score, the greater the pain interferes with patient's activities.This is a well-validated measure of pain-related disability.
The minimum clinically significant difference is 1 point.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in pain intensity, as measured by the Brief Pain Inventory.
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The Brief Pain Inventory (BPI) Pain Severity Scale measures the severity of pain one feels at worst, at least, on average, and at the time of questionnaire completion on a scale from 0 to 10.
The higher the score, the greater the pain severity.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain.
The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Mindfulness will be measured using the Short Form Five Facet Mindfulness Questionnaire (FFMQ-SF).
The FFMQ-SF is a 24-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience.
Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Change in quality of life, as measured by the EuroQOL-5D
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The EuroQOL-5D (EQ-5D) is a simple-to-use, valid, and sensitive instrument measuring quality of life.
It covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 3 levels: no problems, some problems, or severe problems and participants use a tick box to select the statement that is most representative of their conditions.
Participants are also asked to rate, using a visual analogue scale (0 to 100), their state of health.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item scale used to assess the severity of depressive symptoms over the past two weeks and is based on Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for major depression.
Total scores range from 0 to 27, and clinical cut-points correspond to mild, moderate, moderately severe, and severe depression.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Overall change in status from baseline, as measured by Patient Global Impression of Change scale
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The participants' perceived degree of change in overall status will be measured using the Patient Global Impression of Change (PGIC) scale.
The PGIC uses a 7-point likert scale (very much worse, to very much better) to measure how much the participant feels their overall status has changed since the start of the study.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7
Prazo: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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The Generalized Anxiety Disorder - 7 (GAD-7) is a 7-item scale used to assess the severity of anxiety symptoms over the past two weeks.
Total scores range from 0 to 15, and clinical cut-points correspond to mild, moderate, and severe anxiety.
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At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Patricia Poulin, PhD C. Psych, Ottawa Hospital Research Institute
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de setembro de 2022
Conclusão Primária (Antecipado)
1 de março de 2023
Conclusão do estudo (Antecipado)
1 de março de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
19 de março de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de maio de 2018
Primeira postagem (Real)
21 de maio de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de maio de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20180238-01H
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .