Patient Education as TopicNCT02974036
Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
An observational study of Patient Education as Topic and Osteoarthritis, run by Lund University at 1 site in Sweden.
Trial summary
The overall purpose is to study quality in patient education by means of the patients' self-rated enablement. Specific aims are: To assess the validity of the patient enablement instrument in relation to self-efficacy and empowerment; To investigate if patient enablement can be effective in identifying which patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Education as Topic, Osteoarthritis
- What is being tested?
- Patient education for osteoarthritis
- How many people
- 143 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2016to Dec 2019
- Phase
- Observational
- 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
- Patients who are referred to patient education for OA in primary health care
- Speaks and write Swedish
Who cannot join
- Not having OA
- Not able to speak or write Swedish
Trial locations and contacts
1 site in 1 country.
About this study
The overall purpose is to study quality in patient education by means of the patients' self-rated enablement. Specific aims are:
To assess the validity of the patient enablement instrument in relation to self-efficacy and empowerment; To investigate if patient enablement can be effective in identifying which patients would benefit the most from patient education; To study if patient enablement has any relation to self-efficacy, function or self-rated health; To analyze if patient enablement has a causal effect on health care consumption; To evaluate whether patient education is a cost-effective intervention. The project is a longitudinal study, including patients from a patient education programme for osteoarthritis in primary health care. Data consist of patient reported outcome measures and health care consumption. Cost-effectiveness and cost-utility analysis will be used. Inclusion of patients will start August 2016. Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included are from primary health care settings and researchers in the field of OA, patient education and health economy. Our increasingly older and more inactive population will raise huge demands on the health care. The importance of optimizing treatments that are available in primary health care cannot be underestimated. The project will contribute with important knowledge about the patient's own process of getting well.
Read the detailed description
The project is a longitudinal study, including patients who are referred to patient education for osteoarthritis in primary health care and is planned to follow the patients one year before baseline measures as well as one year after baseline measures.
- Conditions
- Patient Education as Topic, Osteoarthritis
- Being tested
- Patient education for osteoarthritis
- Keywords
- Patient education, Osteoarthritis, Primary health care
- 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 for osteoarthritisOther
Group sessions and optional supervised exercise.
| Study group | Role | What they receive |
|---|---|---|
| Patient education for osteoarthritis | The intervention in the education program consists of three group lessons of about 90 minutes each where information about ethiology, risk factors, treatment and coping strategies concerning OA is included. The first two lessons are held by a physiotherapist and the third by a so-called expert patient that is a person with OA who shares his or her experiences of how to live with the disease. After the intervention patients are able to choose if they want to exercise at home or in a group, supervised by a physiotherapist. Receives: Other: Patient education for osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enablement
Questionnaire
Measured: directly after intervention
Secondary outcomes (1)
Arthritis Self Efficacy Scale
Questionnaire
Measured: before intervention, directly after intervention and at 3 and 9 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startAug 2016
- Primary completion18 Oct 2019
- Study completionDec 2019
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 Patient Education as TopicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Ekvall-Hansson, Lund University
- Investigators
- Eva Ekvall Hansson, Ass prof, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974036
- Sponsor's protocol ID
- 782-14
- Status last verified
- Feb 2022
- First submitted
- 17 Aug 2016
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hansson 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 20969809Akesson KS, Sunden A, Stigmar K, Eek F, Pawlikowska T, Hansson EE. Empowerment and enablement and their associations with change in health-related quality of life after a supported osteoarthritis self-management programme - a prospective observational study. Arch Physiother. 2023 Sep 22;13(1):18. doi: 10.1186/s40945-023-00172-7.
PubMed 37735517Akesson KS, Sunden A, Stigmar K, Fagerstrom C, Pawlikowska T, Ekvall Hansson E. Enablement and empowerment among patients participating in a supported osteoarthritis self-management programme - a prospective observational study. BMC Musculoskelet Disord. 2022 Jun 8;23(1):555. doi: 10.1186/s12891-022-05457-9.
PubMed 35676666
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
- ClinicalTrials.gov ID
- NCT02974036
- Acronym / sponsor ID
- 782-14
- Conditions
- Patient Education as Topic, Osteoarthritis
- Keywords
- Patient education, Osteoarthritis, Primary health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Nov 2016 (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 overall purpose is to study quality in patient education by means of the patients' self-rated enablement. Specific aims are:
To assess the validity of the patient enablement instrument in relation to self-efficacy and empowerment; To investigate if patient enablement can be effective in identifying which patients would benefit the most from patient education; To study if patient enablement has any relation to self-efficacy, function or self-rated health; To analyze if patient enablement has a causal effect on health care consumption; To evaluate whether patient education is a cost-effective intervention. The project is a longitudinal study, including patients from a patient education programme for osteoarthritis in primary health care. Data consist of patient reported outcome measures and health care consumption. Cost-effectiveness and cost-utility analysis will be used. Inclusion of patients will start August 2016. Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included are from primary health care settings and researchers in the field of OA, patient education and health economy. Our increasingly older and more inactive population will raise huge demands on the health care. The importance of optimizing treatments that are available in primary health care cannot be underestimated. The project will contribute with important knowledge about the patient's own process of getting well.
Detailed description
The project is a longitudinal study, including patients who are referred to patient education for osteoarthritis in primary health care and is planned to follow the patients one year before baseline measures as well as one year after baseline measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient education for osteoarthritis | – | Other: Patient education for osteoarthritisThe intervention in the education program consists of three group lessons of about 90 minutes each where information about ethiology, risk factors, treatment and coping strategies concerning OA is included. The first two lessons are held by a physiotherapist and the third by a so-called expert patient that is a person with OA who shares his or her experiences of how to live with the disease. After the intervention patients are able to choose if they want to exercise at home or in a group, supervised by a physiotherapist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are referred to patient education for OA in primary health care
- Speaks and write Swedish
Key exclusion criteria (2 listed)
- Not having OA
- Not able to speak or write 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 for osteoarthritisGroup sessions and optional supervised exercise. | Other | Patient education for osteoarthritis |
Primary outcome
Patient enablement
Time frame: directly after intervention
Questionnaire
1 secondary outcome
Arthritis Self Efficacy Scale
Time frame: before intervention, directly after intervention and at 3 and 9 month follow up
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 14 Mar 2022.
- Background: 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.
- Derived from this study: PubMed 37735517Akesson KS, Sunden A, Stigmar K, Eek F, Pawlikowska T, Hansson EE. Empowerment and enablement and their associations with change in health-related quality of life after a supported osteoarthritis self-management programme - a prospective observational study. Arch Physiother. 2023 Sep 22;13(1):18. doi: 10.1186/s40945-023-00172-7.
- Derived from this study: PubMed 35676666Akesson KS, Sunden A, Stigmar K, Fagerstrom C, Pawlikowska T, Ekvall Hansson E. Enablement and empowerment among patients participating in a supported osteoarthritis self-management programme - a prospective observational study. BMC Musculoskelet Disord. 2022 Jun 8;23(1):555. doi: 10.1186/s12891-022-05457-9.
- BOA registryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Patient Education as Topic
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Closing the Gap in Language With Audio Instructions: An Exploratory Pilot Study
Focus on Illiteracy in Patients and Optimal Patient Education
Recruiting
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
Breast Cancer, Cancer of the Breast
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
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, Ass prof 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?
An observational study of Patient Education as Topic and Osteoarthritis, 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 2 inclusion and 2 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 14 Mar 2022. 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?
Patient enablement (time frame: directly after intervention). 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 NCT02974036, 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 14 Mar 2022.