- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472300
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals From Frederiksberg Municipality - A Prospective Cohort Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Although knee pain is prevalent among community-dwelling older adults and frequently leads to consultation in primary care, little is known about how people in general manage their knee pain.
Treatments of knee osteoarthritis include a variety of non-pharmaceutical, medical, and surgical interventions with highly individual and inconsistent results and with the possible exception of a longer lasting weight reduction, none of the non-surgical treatments have been able to demonstrate long-lasting effect on pain or disability.
It is well recognised that patient participation in handling of disease creates better compliance and satisfaction with pharmacological treatment.
Another option for taking active part in self-management is the use of complementary and alternative medicine (CAM). despite their popularity and effect, there is currently no overview of the actual extent of CAMs used for knee pain and disability at a population level, and most CAMs remain to be studied scientifically for efficacy.
The incidence of knee OA shows a steep increase at age above 60 years. Furthermore, after this age an increasing prevalence of disablement to knee trouble is encountered. To prevent this development, measures must be sought to alter the course of knee OA.
By asking people about how knee pain affects their life, which treatments or self-management strategies they have chosen (or are being offered), and how these interact for the reduction of pain and maintenance of function, new knowledge will be gained about the preferences and perceived effectiveness of treatments at large. The information gained will enable the prioritising of research on interventions to be tested and will align this with the primary concerns and interests of the population. This will subsequently lead to better guidance of patients by the health care providers, and will aid decision makers in choosing feasible health care policies and strategies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Danmark
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Frederiksberg, Danmark, Denmark, 2000
- the Parker Institute, Bispebjerg-Frederiksberg Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between 60-69 years of age
- Citizen in the Community of Frederiksberg
Exclusion Criteria:
• No formal exclusion criteria but unability to understand/answer our questionnaire is per se an exclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Frederiksberg Citizens
All citizen in the Frederiksberg Community aged 60-69
|
All citizens are surveyed to describe the prevalence of knee pain in a danish community.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-disclosed knee trouble/pain
Time Frame: 1 Year
|
Population incidence of self-disclosed knee trouble/pain
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-disclosed knee trouble/pain
Time Frame: Annually for 10 years
|
Population incidence of self-disclosed knee trouble/pain
|
Annually for 10 years
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Annually for 10 years
|
Actual KOOS score and scores over time (respondents who report having knee pain)
|
Annually for 10 years
|
|
Brief Illness Perception Questionnaire (IPQ-B)
Time Frame: Annually for 10 years
|
Actual IPQ-B score and scores over time (respondents who report having knee pain). Generic questionnaire developed to measure illness perception. The IPQ-B contains eight items and one causal scale. Items 1-8 are rated using a 0-to-10 response scale, item 9 is a memo field. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). A low score on items number 1,2,5,6 and 8 indicates that the illness is perceived as benign while a low score on the items 3, 4 and 7 indicates that the illness is perceived as threatening. By reversing these three items it is possible to compute an overall score. A higher score reflects a more threatening view of the illness. |
Annually for 10 years
|
|
EQ-5D
Time Frame: Annually for 10 years
|
Actual EQ-5D score and scores over time (all respondents)
|
Annually for 10 years
|
|
Treatments of all kinds
Time Frame: Annually for 10 years
|
To estimate the use of treatments of all kinds (both in the "established" health care system and as self-management), including use of non-pharmacological treatments
|
Annually for 10 years
|
|
Influence of treatments (longitudinal)
Time Frame: Annually for 10 years
|
Influence of treatments and their combination on use of health care system including surgical procedures.
|
Annually for 10 years
|
Collaborators and Investigators
Investigators
- Study Chair: Elisabeth Ginnerup, The Parker Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FrbCohort-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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