- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03531476
Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN (Shared-Care)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Patricia Poulin, PhD C. Psych
- 전화번호: 73903 6137378899
- 이메일: ppoulin@toh.ca
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1H8L6
- Ottawa Hospital Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in pain intensity, as measured by the Brief Pain Inventory.
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Patricia Poulin, PhD C. Psych, Ottawa Hospital Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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