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Research Question
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Not provided at time of registration (from ISRCTN)
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Ethics Approval
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11/WM/0093; First MREC approval date 04/04/2011
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Study Design
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Randomised; Interventional; Design type: Screening
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Osteoarthritis
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Participants Inclusion Criteria
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1. Aged 45 years and over
2. Registered with the participating GP practices during the specified study period of that practice
3. Read-coded peripheral joint pain or OA consultation within the specified study period (termed the index consultation)
4. May be first, new episode, or ongoing consultation)
5. Provided full written informed consent to study participation and to further contact 6. Male & female
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Participants Exclusion Criteria
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1. Patients who are under active care for or who have a diagnosis of depression and/or an anxiety disorder in the past 12 months
2. Vulnerable patients, including any patients on the Quality and Outcomes Framework mental health register, or those who have a diagnosis of dementia or a terminal illness
3. Patients who reside in a nursing home
4. Red flag pathology
5. Recent trauma associated with significant injury
6. Acute, red, hot swollen joint
7. Inflammatory arthropathy, crystal disease, spondyloarthropathy and polymyalgia rheumatic
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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Planned Sample Size: 1309; UK Sample Size: 1309
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Completed
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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Newcastle under Lyme
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Interventions
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Generalised Anxiety Disorderr-2 (GAD-2)
1. Eligible patients in the intervention arm consulting their GP for osteoarthritis or joint pain will be asked these 4 questions on depressive and anxiety symptoms during their consultation:
1.1. Modified Patient Hlth Quest
1.2. Modified Patient Health Questionnaire (PHQ-2)
2. Eligible patients in the intervention arm consulting their GP for osteoarthritis or joint pain will be asked these 4 questions on depressive and anxiety symptoms during their consultation
3. Follow up length: 12 months
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Primary Outcome Measures
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1. Self report measure of current pain intensity measured at baseline, 3 months, 6 months and 12 months
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Secondary Outcome Measures
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1. Anxiety (GAD-7 (5)) at baseline, 3 months, 6 months and 12 months
2. Body mass index (from self reported height and weight) at baseline, 3 months, 6 months and 12 months
3. Characteristic Pain Intensity and Disability Score at baseline, 3 months, 6 months and 12 months
4. Demographics (marital status and occupation/employment details) at baseline, 3 months, 6 months and 12 months
5. Depression (PHQ-8 (4)) at baseline, 3 months, 6 months and 12 months
6. Detailed questions about pain at baseline, 3 months, 6 months and 12 months
7. Medication and health care use at baseline, 3 months, 6 months and 12 months
8. Overall quality of life (EQ5D (2) and SF-36 (3)) at baseline, 3 months, 6 months and 12 months
9. Pain Catastrophising Scale (6) at baseline, 3 months, 6 months and 12 months
10. Pain interference with daily activities at baseline, 3 months, 6 months and 12 months
11. Social support (questions taken from previous postal surveys) at baseline, 3 months, 6 months and 12 months
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Website
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Sorry, not currently available
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