跳至主要内容
临床试验/NCT03531476
NCT03531476Unknown不适用

Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
2
主要终点
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-years or older
  • ability to understand oral and written English
  • report chronic pain (≥3months)

排除标准

  • 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

结局指标

主要结局

Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)

时间窗: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

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.

次要结局

  • Change in quality of life, as measured by the EuroQOL-5D(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change in pain intensity, as measured by the Brief Pain Inventory.(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Overall change in status from baseline, as measured by Patient Global Impression of Change scale(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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