Community-based Intervention for Fibromyalgia: A Pilot Trial
2019年10月7日 更新者:Nelly Oelke、University of British Columbia
A Multi-disciplinary, Community-based Group Intervention for Fibromyalgia: A Pilot Randomized Controlled Trial
Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating and heterogeneous symptoms.
This leads to both reduced patient function and quality of life and consequentially, significant economic burden on the society.
Although numerous pharmaceutical and multi-treatment approaches exist, there is lack of an integrated multidisciplinary model of care for these patients.
Such a system is hypothesized to be beneficial for the patients and would help them regain function and significantly improve their quality of life.
The primary aim of this pilot clinical trial is to evaluate the effectiveness of an integrated community-based multidisciplinary model of care for FM patients in Penticton and surrounding areas.
The comprehensive 10 week intervention will provide care from a team of health care providers (psychiatrist, physiotherapist, certified exercise therapist, dietitian, rheumatologist, and mental health clinician).
Patients will also attend a peer led pain self-management support group provided by the Arthritis Society.
The study aims at educating these patients about self-management of their symptoms such as chronic pain, weight, sleep and mood disorders.
The integration of health care between the different providers will be achieved by "huddle" sessions that will be conducted on a monthly basis.
The evaluation of the study outcomes will be based on the RE-AIM framework.
Data will be collected through patient questionnaires, healthcare utilization data, and interviews with providers.
Data analysis will involve thematic analysis of qualitative data and statistical methods for quantitative data.
研究概览
研究类型
介入性
注册 (实际的)
84
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Penticton、British Columbia、加拿大、V2A 4Z1
- Balfour Medical Centre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- formal diagnosis of FM
- resident of Penticton or surrounding area
- adults, aged 19 and older
- fluent in English or bring a family member/friend to assist with translation
- capacity to provide informed consent
Exclusion Criteria:
- patients with a severe and/or chronic medical or psychiatric condition that would impact ability to participate in the intervention
- patients who are pregnant or lactating
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Multidisciplinary intervention
The 10-week intervention will include twice weekly 1-2 hours sessions with multiple professional team members to undergo education and exercise sessions.
The multidisciplinary team will consist of a rheumatologist, rheumatology nurse, dietitian, physiotherapist, a trained exercise therapist, a physiologist who specializes in pain management, a psychiatrist and a mental health clinician.
All intervention team members have expertise in working with individuals with chronic pain conditions.
General disease information, current best practices and techniques such as self-pain management, pacing, sleep hygiene, approach to a healthy lifestyle and weight loss will be discussed.
The total number of hours for the 10 week intervention is 31 hours.
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10 week multidisciplinary education and exercise
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无干预:Usual care
Usual care involves being referred to the local rheumatologist involved in the study.
The rheumatologist and the rheumatology nurse will see the control group patients during a one hour one on one consultation appointment.
During that time the patient's history will be taken, physical exam performed and investigations analyzed.
If a diagnosis of fibromyalgia is confirmed, the rheumatologist and nurse will counsel the patient and provide resources for self directed management.
Unless there is a concern of an alternative diagnosis, follow up will not be arranged.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient-perceived quality of care
大体时间:Change from baseline in perceived quality of care at 10 weeks and 6 months
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Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire
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Change from baseline in perceived quality of care at 10 weeks and 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Daily function #1
大体时间:Change from baseline in daily function at 10 weeks and 6 months
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Physical disease and mental health related functioning as measured by Revised-Fibromyalgia Impact Questionnaire
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Change from baseline in daily function at 10 weeks and 6 months
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Daily function #2
大体时间:Change from baseline in daily function at 10 weeks and 6 months
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Mental health related functioning as measured by Hospital Anxiety and Depression scale
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Change from baseline in daily function at 10 weeks and 6 months
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Health care utilization (physician visits)
大体时间:Change from baseline in physician visits at 6 months
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Number of physician visits
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Change from baseline in physician visits at 6 months
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Health care utilization (emergency visits)
大体时间:Change from baseline in emergency department visits at 6 months
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Number of emergency department visits
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Change from baseline in emergency department visits at 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sleep quality
大体时间:Change from baseline in sleep quality at 10 weeks
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Quality of sleep as measured by Sleep scale - medical outcome scale
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Change from baseline in sleep quality at 10 weeks
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Sleep quality
大体时间:Change from baseline in sleep quality at 6 months
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Quality of sleep as measured by Sleep scale - medical outcome scale
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Change from baseline in sleep quality at 6 months
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Attitudes of pain
大体时间:Change from baseline in pain attitudes at 10 weeks and 6 months
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Measurement of pain through Survey of brief attitudes of pain
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Change from baseline in pain attitudes at 10 weeks and 6 months
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Irritability
大体时间:Change from baseline in irritability at 10 weeks
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Irritability measured by Brief Irritability Test (BITe) questionnaire
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Change from baseline in irritability at 10 weeks
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Irritability
大体时间:Change from baseline in irritability at 6 months
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Irritability measured by Brief Irritability Test (BITe) questionnaire
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Change from baseline in irritability at 6 months
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Patient perspectives on self-management resources
大体时间:10 weeks
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Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
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10 weeks
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Patient perspectives on self-management resources
大体时间:6 months
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Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
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6 months
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Provider perspectives on quality of care
大体时间:18 months
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Interviews will be conducted to gather providers' perspectives on the model of care
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18 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michelle Teo、University of British Columbia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10. Erratum In: Arthritis Res Ther. 2009;11(5):415.
- Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.
- Schaefer C, Chandran A, Hufstader M, Baik R, McNett M, Goldenberg D, Gerwin R, Zlateva G. The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States. Health Qual Life Outcomes. 2011 Aug 22;9:71. doi: 10.1186/1477-7525-9-71.
- Lachaine J, Beauchemin C, Landry PA. Clinical and economic characteristics of patients with fibromyalgia syndrome. Clin J Pain. 2010 May;26(4):284-90. doi: 10.1097/AJP.0b013e3181cf599f.
- Thompson JM, Luedtke CA, Oh TH, Shah ND, Long KH, King S, Branda M, Swanson R. Direct medical costs in patients with fibromyalgia: Cost of illness and impact of a brief multidisciplinary treatment program. Am J Phys Med Rehabil. 2011 Jan;90(1):40-6. doi: 10.1097/PHM.0b013e3181fc7ff3.
- Winkelmann A, Perrot S, Schaefer C, Ryan K, Chandran A, Sadosky A, Zlateva G. Impact of fibromyalgia severity on health economic costs: results from a European cross-sectional study. Appl Health Econ Health Policy. 2011 Mar 1;9(2):125-36. doi: 10.2165/11535250-000000000-00000.
- Bellato E, Marini E, Castoldi F, Barbasetti N, Mattei L, Bonasia DE, Blonna D. Fibromyalgia syndrome: etiology, pathogenesis, diagnosis, and treatment. Pain Res Treat. 2012;2012:426130. doi: 10.1155/2012/426130. Epub 2012 Nov 4. Erratum In: Pain Res Treat. 2013;2013:960270.
- Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013 Jun;103(6):e38-46. doi: 10.2105/AJPH.2013.301299. Epub 2013 Apr 18.
- Richards L, Morse J. Read me first for a users guide to qualitative methods. (3rd ed.) Sage Publications, Inc. 2013.
- Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer Science & Business Media; 2009.
- Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. doi: 10.1097/01.mlr.0000160375.47920.8c.
- Nam S, Tin D, Bain L, Thorne JC, Ginsburg L. Clinical utility of the Hospital Anxiety and Depression Scale (HADS) for an outpatient fibromyalgia education program. Clin Rheumatol. 2014 May;33(5):685-92. doi: 10.1007/s10067-013-2377-1. Epub 2013 Sep 1.
- Cappelleri JC, Bushmakin AG, McDermott AM, Dukes E, Sadosky A, Petrie CD, Martin S. Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia. Sleep Med. 2009 Aug;10(7):766-70. doi: 10.1016/j.sleep.2008.09.004. Epub 2009 Jan 29.
- Tait RC, Chibnall JT. Development of a brief version of the Survey of Pain Attitudes. Pain. 1997 Apr;70(2-3):229-35. doi: 10.1016/s0304-3959(97)03330-7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月15日
初级完成 (实际的)
2019年6月30日
研究完成 (实际的)
2019年6月30日
研究注册日期
首次提交
2017年8月21日
首先提交符合 QC 标准的
2017年8月31日
首次发布 (实际的)
2017年9月1日
研究记录更新
最后更新发布 (实际的)
2019年10月9日
上次提交的符合 QC 标准的更新
2019年10月7日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Multidisciplinary intervention的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人