Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN (Shared-Care)
2022年4月29日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
240
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Patricia Poulin, PhD C. Psych
- 電話番号：73903 6137378899
- メール：ppoulin@toh.ca
研究場所
-
-
Ontario
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Ottawa、Ontario、カナダ、K1H8L6
- Ottawa Hospital Research Institute
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
時間枠：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.
|
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pain intensity, as measured by the Brief Pain Inventory.
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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
|
|
Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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.
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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.
|
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
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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
時間枠：At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
|
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.
|
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Patricia Poulin, PhD C. Psych、Ottawa Hospital Research Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年9月1日
一次修了 (予想される)
2023年3月1日
研究の完了 (予想される)
2023年3月1日
試験登録日
最初に提出
2018年3月19日
QC基準を満たした最初の提出物
2018年5月8日
最初の投稿 (実際)
2018年5月21日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月2日
QC基準を満たした最後の更新が送信されました
2022年4月29日
最終確認日
2022年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。