PolyarthritisNCT00623922
Effect of Patient Education in Rheumatic Diseases
A study testing Patient education with individual nurse consultations in people with Polyarthritis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polyarthritis
- What is being tested?
- Patient education with individual nurse consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2008to Mar 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Polyarthritis
- 18-80 years
- native Norwegian speaking
- able to understand and participate in the PE program
Who cannot join
- Participated in a patient educational program the latest 12 months
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology and St. Olavs Hospital HF
Trondheim, Trondheim, 7489
About this study
Official title: The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Our hypothesis is that
- PE delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.
Read the detailed description
There has been a rather long tradition of PE for patients with arthritis. A recent systematic review found that PE had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months). A recent large British study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy. This indicates that the present forms of interventions fails to show a long term effect. One possible reason for the lack of long term effect might be that these interventions are given to groups only. Patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.
- Conditions
- Polyarthritis
- Being tested
- Patient education with individual nurse consultations
- Keywords
- Patient education, Nurse consultation, Arthritis, Wellbeing, Coping, Health related quality of life
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education with individual nurse consultationsBehavioural
3 group meetings followed by 1-2 individual nurse consultations.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient education Receives: Behavioral: Patient education with individual nurse consultations |
| 2 | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self efficacy
Measured: Baseline, 4 and 12 months
Well being (Arizona Integrative Outcomes Scale)
Measured: Baseline, 4 and 12 months
Secondary outcomes (11)
Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
Measured: Baseline, 4 and 12 months
The Hospital Anxiety and Depression Scale
Measured: Baseline, 4 and 12 months
Educational Needs Assessment Tools
Measured: Baseline, 4 and 12 months
Modified Health Assessment Questionnaire
Measured: Baseline, 4 and 12 months
DAS 28 score (Disease activity score)
Measured: Baseline, 4 and 12 months
Patient Activation Measurement (PAM)
Measured: Baseline, 4 and 12 months
Cost- benefit
Measured: Baseline, 4 and 12 months
Physical activity
Measured: Baseline, 4 and 12 months
Use of medications
Measured: Baseline, 4 and 12 months
fatigue (VAS scale)
Measured: Baseline, 4 and 12 months
Pain (VAS scale)
Measured: Baseline, 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PolyarthritisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, Principal investigator, Norwegian University of Science and TechnologyKjersti Grønning, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623922
- Sponsor's protocol ID
- 4.2007.2472
- Other IDs
- NSD 17975
- Status last verified
- Apr 2015
- First submitted
- 12 Feb 2008
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Riemsma RP, Taal E, Kirwan JR, Rasker JJ. Systematic review of rheumatoid arthritis patient education. Arthritis Rheum. 2004 Dec 15;51(6):1045-59. doi: 10.1002/art.20823. No abstract available.
PubMed 15593105Gronning K, Skomsvoll JF, Rannestad T, Steinsbekk A. The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial. Patient Educ Couns. 2012 Jul;88(1):113-20. doi: 10.1016/j.pec.2011.12.011. Epub 2012 Jan 23.
PubMed 22277625Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
PubMed 23875718Gronning K, Midttun L, Steinsbekk A. Patients' confidence in coping with arthritis after nurse-led education; a qualitative study. BMC Nurs. 2016 May 4;15:28. doi: 10.1186/s12912-016-0150-x. eCollection 2016.
PubMed 27147905
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
- ClinicalTrials.gov ID
- NCT00623922
- Acronym / sponsor ID
- 4.2007.2472
- Conditions
- Polyarthritis
- Keywords
- Patient education, Nurse consultation, Arthritis, Wellbeing, Coping, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Feb 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Feb 2008 (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.
The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Our hypothesis is that
- PE delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.
Detailed description
There has been a rather long tradition of PE for patients with arthritis. A recent systematic review found that PE had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months). A recent large British study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy. This indicates that the present forms of interventions fails to show a long term effect. One possible reason for the lack of long term effect might be that these interventions are given to groups only. Patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient education with individual nurse consultationsPatient education |
| 2 | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Polyarthritis
- 18-80 years
- native Norwegian speaking
- able to understand and participate in the PE program
Key exclusion criteria (1 listed)
- Participated in a patient educational program the latest 12 months
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 with individual nurse consultations3 group meetings followed by 1-2 individual nurse consultations. | Behavioural | 1 |
Primary outcome
Self efficacy
Time frame: Baseline, 4 and 12 months
Well being (Arizona Integrative Outcomes Scale)
Time frame: Baseline, 4 and 12 months
11 secondary outcomes
Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
Time frame: Baseline, 4 and 12 months
The Hospital Anxiety and Depression Scale
Time frame: Baseline, 4 and 12 months
Educational Needs Assessment Tools
Time frame: Baseline, 4 and 12 months
Modified Health Assessment Questionnaire
Time frame: Baseline, 4 and 12 months
DAS 28 score (Disease activity score)
Time frame: Baseline, 4 and 12 months
Patient Activation Measurement (PAM)
Time frame: Baseline, 4 and 12 months
Cost- benefit
Time frame: Baseline, 4 and 12 months
Physical activity
Time frame: Baseline, 4 and 12 months
Use of medications
Time frame: Baseline, 4 and 12 months
fatigue (VAS scale)
Time frame: Baseline, 4 and 12 months
Pain (VAS scale)
Time frame: Baseline, 4 and 12 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 8 Apr 2015.
- Background: PubMed 15593105Riemsma RP, Taal E, Kirwan JR, Rasker JJ. Systematic review of rheumatoid arthritis patient education. Arthritis Rheum. 2004 Dec 15;51(6):1045-59. doi: 10.1002/art.20823. No abstract available.
- Results publication: PubMed 22277625Gronning K, Skomsvoll JF, Rannestad T, Steinsbekk A. The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial. Patient Educ Couns. 2012 Jul;88(1):113-20. doi: 10.1016/j.pec.2011.12.011. Epub 2012 Jan 23.
- Results publication: PubMed 23875718Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
- Derived from this study: PubMed 27147905Gronning K, Midttun L, Steinsbekk A. Patients' confidence in coping with arthritis after nurse-led education; a qualitative study. BMC Nurs. 2016 May 4;15:28. doi: 10.1186/s12912-016-0150-x. eCollection 2016.
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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.
Aslak Steinsbekk principal investigator
Norwegian University of Science and Technology
Kjersti Grønning principal investigator
Norwegian University of Science and Technology
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 with individual nurse consultations in people with Polyarthritis, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 8 Apr 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 Norway. 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?
Self efficacy (time frame: Baseline, 4 and 12 months). The study lists 2 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 NCT00623922, which also lists 4 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 8 Apr 2015.