Osteoarthritis in the Hip, Knee and HandNCT00979914
Effect of an Education Programme for Patients With Osteoarthritis in Primary Care - a Randomized Controlled Trial
A study testing Patient education programme in people with Osteoarthritis in the Hip, Knee and Hand, run by Lund University at 1 site in Sweden.
Trial summary
Osteoarthritis is a common disease. The core treatment is often patient education. The aim of this study is therefore to study the effect of a patient education programme for patients with osteoarthritis in primary health care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis in the Hip, Knee and Hand
- What is being tested?
- Patient education programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoarthritis
Who cannot join
- Must be able to speak and understand swedish
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis is a common disease. The core treatment is often patient education. The aim of this study is therefore to study the effect of a patient education programme for patients with osteoarthritis in primary health care.
Read the detailed description
Osteoarthritis (OA) is a degenerative disease, considered to be one of the major national diseases that cause suffering for affected patients and costs for society.The predominant symptoms are pain, stiffness and impaired quality of life, often together with psychological distress. Treatment often consists of medication. Later in the disease, when the joint is destroyed, joint replacement surgery commonly occurs. Physical exercises aimed to increase muscle strength, endurance, proprioception and stability have proved to influence cartilage as well as function, symptoms and quality of life positively. Physical exercise may also reduce the need for hospital care after knee joint replacement.
Research suggests that patient education is feasible and valuable in terms of improvements in quality of life, in function, in well-being and improved coping . Accordingly, guidelines recommend education as a core treatment for osteoarthritis.
Patient education programmes are often defined as a planned learning experience to influence a patient's knowledge and health behaviour [13]. There are various types of patient education. It can be given by a physician as part of consultation, in small groups or delivered by a multi-disciplinary team [13, 14] Since 1994, Primary Health Care in Malmö has used a patient education programme directed towards OA. The programme has been developed by physiotherapists and occupational therapists in primary health care and has been implemented in the ordinary work.
- Conditions
- Osteoarthritis in the Hip, Knee and Hand
- Being tested
- Patient education programme
- Keywords
- osteoarthritis, patient education, function, physio therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education programmeOther
The intervention consisted of five group sessions, three hours for each session. The focus was on self-efficacy. Eight to ten patients participated in the programme at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Patient education programme | Experimental | Patients with osteoarthritis who were referred to the patient education programme.The patients followed the patient education programme. Receives: Other: Patient education programme |
| Control | No intervention | Patients randomized to control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D
Measured: At baseline and at follow-up after 6 months
Arthritis self-efficacy scale
Measured: At baseline and at follow up after 6 months
One-leg rising from sitting to standing
Measured: At baseline and at follow up after 6 months
Grip Ability Test
Measured: At baseline and at follow up after 6 months
Secondary outcomes (3)
Bipedal rising from sitting to standing
Measured: At baseline and at follow up after 6 months
One-legged jump
Measured: At baseline and at follow up after 6 months
Standing on one leg with eyes open and standing on one leg with eyes closed
Measured: At baseline and at follow up after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis in the Hip, Knee and HandStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, Eva Ekvall Hansson, Lund University
- Investigators
- Eva Ekvall Hansson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979914
- Sponsor's protocol ID
- PEPOA
- Status last verified
- Mar 2015
- First submitted
- 17 Sep 2009
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosemann T, Joos S, Laux G, Gensichen J, Szecsenyi J. Case management of arthritis patients in primary care: a cluster-randomized controlled trial. Arthritis Rheum. 2007 Dec 15;57(8):1390-7. doi: 10.1002/art.23080.
PubMed 18050178Fransen M, Edmonds J. Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):807-13. doi: 10.1093/rheumatology/38.9.807.
PubMed 10515639Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.
PubMed 20969809
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Education Programme for Patients With Osteoarthritis in Primary Care - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00979914
- Acronym / sponsor ID
- PEPOA
- Conditions
- Osteoarthritis in the Hip, Knee and Hand
- Keywords
- osteoarthritis, patient education, function, physio therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is a common disease. The core treatment is often patient education. The aim of this study is therefore to study the effect of a patient education programme for patients with osteoarthritis in primary health care.
Detailed description
Osteoarthritis (OA) is a degenerative disease, considered to be one of the major national diseases that cause suffering for affected patients and costs for society.The predominant symptoms are pain, stiffness and impaired quality of life, often together with psychological distress. Treatment often consists of medication. Later in the disease, when the joint is destroyed, joint replacement surgery commonly occurs. Physical exercises aimed to increase muscle strength, endurance, proprioception and stability have proved to influence cartilage as well as function, symptoms and quality of life positively. Physical exercise may also reduce the need for hospital care after knee joint replacement.
Research suggests that patient education is feasible and valuable in terms of improvements in quality of life, in function, in well-being and improved coping . Accordingly, guidelines recommend education as a core treatment for osteoarthritis.
Patient education programmes are often defined as a planned learning experience to influence a patient's knowledge and health behaviour [13]. There are various types of patient education. It can be given by a physician as part of consultation, in small groups or delivered by a multi-disciplinary team [13, 14] Since 1994, Primary Health Care in Malmö has used a patient education programme directed towards OA. The programme has been developed by physiotherapists and occupational therapists in primary health care and has been implemented in the ordinary work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education programme | Experimental | Other: Patient education programmePatients with osteoarthritis who were referred to the patient education programme.The patients followed the patient education programme. |
| Control | No intervention | –Patients randomized to control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of osteoarthritis
Key exclusion criteria (1 listed)
- Must be able to speak and understand swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education programmeThe intervention consisted of five group sessions, three hours for each session. The focus was on self-efficacy. Eight to ten patients participated in the programme at the same time. | Other | Patient education programme |
Primary outcome
EQ5D
Time frame: At baseline and at follow-up after 6 months
Arthritis self-efficacy scale
Time frame: At baseline and at follow up after 6 months
One-leg rising from sitting to standing
Time frame: At baseline and at follow up after 6 months
Grip Ability Test
Time frame: At baseline and at follow up after 6 months
3 secondary outcomes
Bipedal rising from sitting to standing
Time frame: At baseline and at follow up after 6 months
One-legged jump
Time frame: At baseline and at follow up after 6 months
Standing on one leg with eyes open and standing on one leg with eyes closed
Time frame: At baseline and at follow up after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Background: PubMed 18050178Rosemann T, Joos S, Laux G, Gensichen J, Szecsenyi J. Case management of arthritis patients in primary care: a cluster-randomized controlled trial. Arthritis Rheum. 2007 Dec 15;57(8):1390-7. doi: 10.1002/art.23080.
- Background: PubMed 10515639Fransen M, Edmonds J. Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):807-13. doi: 10.1093/rheumatology/38.9.807.
- Derived from this study: PubMed 20969809Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.
- Description of the EQ5DLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ekvall Hansson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education programme in people with Osteoarthritis in the Hip, Knee and Hand, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ5D (time frame: At baseline and at follow-up after 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.