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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02884531 |
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Date of registration:
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22/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial
HipOA |
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Scientific title:
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Assessment and Treatment Responses to Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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101 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02884531 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Liv I Strand, Dr.philos. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Bergen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women and men with primary OA according to the American College of Rheumatology
Clinical Criteria, living in Bergen or within a reasonable travelling distance (judged
by the patients).
Exclusion Criteria:
- Other known major physical or mental problems or disease that precludes movement
training and participation in an educational program, known drug abuse, not speaking
or understanding Norwegian language, pregnancy 5-9 months.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hip Osteoarthritis
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Intervention(s)
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Behavioral: Patient Education
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Other: Patient Education and Basic Body Awareness Therapy
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Primary Outcome(s)
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Hip disability and Osteoarthritis Outcome Score (HOOS), change in ADL
[Time Frame: Baseline, 4 months and 1 year]
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Numeric Rating Scale, change in pain
[Time Frame: Baseline, 4 months and 1 year]
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Secondary Outcome(s)
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Body Awareness Rating Scale (BARS)
[Time Frame: Baseline, 4 months]
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Chair test.
[Time Frame: Baseline, 4 months]
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Stairs test.
[Time Frame: Baseline, 4 months]
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Arthritis Self-efficacy Scale (ASES)
[Time Frame: Baseline, 4 months and 1 year]
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UCLA Activity Score
[Time Frame: Baseline, 4 months and 1 year]
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The EuroQol (EQ-5D-5L)
[Time Frame: Baseline, 4 months and 1 year]
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Harris Hip Score (HHS)
[Time Frame: Baseline, 4 months and 1 year]
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6-minutes walking - test
[Time Frame: Baseline, 4 months]
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The Patient Global Impression of Change (PGIC)
[Time Frame: 4 months and 1 year]
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Secondary ID(s)
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Hip osteoarthritis RCT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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