Back to resultsA Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting (LEAP)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Living Everyday Above-and-beyond Pain (LEAP)
Wait-listed
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring Chronic pain, Primary care, Multidisciplinary group therapy, Embedded mixed-methods study
Eligibility Criteria
Inclusion Criteria:
- 18 years and older
- diagnosed with chronic pain
Exclusion Criteria:
- chronic pain related to cancer, pelvic pain or headache
- inability to speak or write in English
- patient is unable to attend and participate in group treatment sessions on their own
- substance use or mental health problems of a severity making group treatment participation impossible
- currently participating in another cognitive-behavioral pain management program
- patient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year
Sites / Locations
- McMaster Family Practice Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Early Intervention Group
Delayed Intervention Group
Arm Description
Initially wait-listed and served as control group. But later participants underwent the experimental intervention.
Outcomes
Primary Outcome Measures
Quality of Life
This will utilize the SF-36 QOL questionnaire.
Health care utilization
This will be based on a chart review to assess the number of consultations with their family physician and other clinicians (Nurse practitioners, registered nurse, dietitian, social worker).
Secondary Outcome Measures
Qualitative process evaluation (Perceptions of participants regarding the intervention)
This outcome assesses the views of the participants regarding the strengths and weaknesses of the intervention. It will assess ways to improve the recruitment process and retention of participants in the group, satisfaction of the participants regarding the processes (group dynamics, time, format, contents, etc), perceptions of participants regarding the effectiveness of the program, and suggestion of participants regarding ways to improve the program.
Pain medication use
This will be based on a standardized questionnaire developed by the researchers and a chart review regarding request for early refill and increased dose of medications due to worsening of chronic pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01517256
Brief Title
A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Acronym
LEAP
Official Title
Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
5. Study Description
Brief Summary
The investigators will evaluate the effectiveness of "Living Everyday Above-and-beyond Pain" (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life, interaction with the health care system and their health care utilization. This is a pilot study to evaluate mainly feasibility. The investigators will make use of both experimental and qualitative methods gather evidence of the programs success, strengths and weaknesses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Primary care, Multidisciplinary group therapy, Embedded mixed-methods study
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Intervention Group
Arm Type
Experimental
Arm Title
Delayed Intervention Group
Arm Type
Placebo Comparator
Arm Description
Initially wait-listed and served as control group. But later participants underwent the experimental intervention.
Intervention Type
Behavioral
Intervention Name(s)
Living Everyday Above-and-beyond Pain (LEAP)
Intervention Description
8-week multidisciplinary group therapy aiming consisting of education about the nature of chronic pain, pacing and goal setting, mindfulness medication techniques, cognitive reflections on beliefs, impulses and obsessions, physical activation, and medication management.
Intervention Type
Other
Intervention Name(s)
Wait-listed
Intervention Description
Patients are wait-listed while awaiting participation to the LEAP program.
Primary Outcome Measure Information:
Title
Quality of Life
Description
This will utilize the SF-36 QOL questionnaire.
Time Frame
8 months
Title
Health care utilization
Description
This will be based on a chart review to assess the number of consultations with their family physician and other clinicians (Nurse practitioners, registered nurse, dietitian, social worker).
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Qualitative process evaluation (Perceptions of participants regarding the intervention)
Description
This outcome assesses the views of the participants regarding the strengths and weaknesses of the intervention. It will assess ways to improve the recruitment process and retention of participants in the group, satisfaction of the participants regarding the processes (group dynamics, time, format, contents, etc), perceptions of participants regarding the effectiveness of the program, and suggestion of participants regarding ways to improve the program.
Time Frame
16 months
Title
Pain medication use
Description
This will be based on a standardized questionnaire developed by the researchers and a chart review regarding request for early refill and increased dose of medications due to worsening of chronic pain.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older
diagnosed with chronic pain
Exclusion Criteria:
chronic pain related to cancer, pelvic pain or headache
inability to speak or write in English
patient is unable to attend and participate in group treatment sessions on their own
substance use or mental health problems of a severity making group treatment participation impossible
currently participating in another cognitive-behavioral pain management program
patient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year
Facility Information:
Facility Name
McMaster Family Practice Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1A4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23875181
Citation
Angeles RN, Guenter D, McCarthy L, Bauer M, Wolfson M, Chacon M, Bullock L. Group interprofessional chronic pain management in the primary care setting: a pilot study of feasibility and effectiveness in a family health team in Ontario. Pain Res Manag. 2013 Sep-Oct;18(5):237-42. doi: 10.1155/2013/491279. Epub 2013 Jul 19.
Results Reference
derived
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A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
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