OsteoarthritisNCT04816474
The Effects of Disease Management Training and Telephone Counseling Service for Elderly Patients With Osteoarthritis
A study testing Online education and Phone Counseling Service in people with Osteoarthritis, run by KTO Karatay University at 2 sites in Turkey (Türkiye).
Trial summary
The study will be conducted to determine the difference on functional status, self-efficacy, and quality of life between groups with and without telephone counseling and training on disease management for participants. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Online education and Phone Counseling Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Aug 2021to 10 Jan 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 and over
- OA was diagnosed by the physician according to the American College of Rheumatology (ARD) criteria,
- Being able to answer research questions
- Individuals who gave their oral and written consent to participate in the study were included.
Who cannot join
- Having a history of malignancy
- Those who score above 5 points from the Visual Analogue Scale
- With a neuro psychiatric illness
- Having vision and hearing problems
- Receiving intraarticular medication (steroid, chondramine, hyaluronic acid) in the last month
- Surgery applied to the knee joint in the last 3 months
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- Having inflammation in the joints
- Have an open wound in the OA area
- Individuals with a diagnosed vascular disease will not be included.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Akademi Hastanesi
Konya, 42000
Konya Meram Akademi Hastanesi
Konya, 42020
About this study
Official title: The Effect of Training on Disease Management and Phone Counseling Service for Older Patients With Osteoarthritis on Functional Status, Self-Efficacy and Quality of Life
The study will be conducted to determine the difference on functional status, self-efficacy, and quality of life between groups with and without telephone counseling and training on disease management for participants.
Read the detailed description
When the literature is examined, in patients with osteoarthritis who receive face-to-face training and intermittent telephone counseling; It is observed that the level of self-efficacy, compliance with the disease and quality of life have increased. It is stated that face-to-face training and telephone counseling services provided to participants on disease management will increase the effectiveness of education and as a result; It is thought that participants may have positive outcomes such as expressing their problems more easily, feeling safer by communicating frequently, and developing methods of coping with nurse-patient cooperation. When the studies conducted in our country are examined, while there are studies examining the effect of non-pharmacological interventions such as acupressor, hot-cold application, exercise training, mud pack treatment in patients with osteoarthritis; No study was found in the elderly patient group in which education and telephone counseling were conducted. The results of the research are thought to be beneficial in managing the disease in addition to in addition to pharmacological treatment.
- Conditions
- Osteoarthritis
- Being tested
- Online education and Phone Counseling Service
- Keywords
- Osteoarthritis, nurse, self-efficacy, quality of life, functional status
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online education and Phone Counseling ServiceBehavioural
Online education total of 6 times for 6 weeks. Phone Counseling Service total of 6 times for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Education and Phone Counseling Service | Experimental | Patients in this group will be trained online for 6 weeks. After the online training is over, a telephone consultation service will be provided once a week for 6 weeks. Receives: Behavioral: Online education and Phone Counseling Service |
| Control | No intervention | No application will be made to patients in this group for 12 weeks. Pre-test and post-test will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in functional status at 6 weeks and 12. weeks.
After the training and counseling, the functional status scores of the patients are checked. The Western 45 Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale has undergone several revisions. WOMAC; It consists of three subgroups: pain during various positions and movements, severity of joint stiffness, and difficulty in performing daily life activities. A total of 24 questions (pain 5, joint stiffness 2, physical function 17) and 5-point likert. In the evaluation, the questions are scored between 0 and 4 according to the Likert scale. The first option "no pain" is calculated as 0 points, the last option "very severe pain" is calculated as 4 points. Maximum scores of subgroups; 20 for pain, 8 for joint stiffness and 68 for physical function. The total score for each subgroup is the sum of the scores given to each item. As the scores get higher, symptoms worsen, restriction increases, and general health deteriorates.
Measured: [Baseline, 6 weeks and 12 weeks]
Secondary outcomes (1)
Change from baseline in self-efficacy at 6 weeks and 12. weeks.
After the interventions, the patient's self-efficacy scores are checked. Self-Efficacy Scale in Arthritis; It consists of 20 expressions evaluated on a visual scale with 10 digits, whose starting point is "I'm not sure = 1" and the other end is "I'm very sure = 10". It has four sub-dimensions: self-efficacy pain, self-efficacy hand and arm functions, self-efficacy foot leg functions and self-efficacy other symptoms. The first five statements are included in the self-efficacy pain sub-dimension and determine the level of pain coping in arthritis patients. The next nine statements are named self-efficacy hand-arm functions and self-efficacy foot leg functions, and are the two sub-dimensions of self-efficacy functions in the original. The minimum score of the scale is 20 and the maximum score is 200, and the higher the score is the indicator of the higher self-efficacy level.
Measured: [Baseline, 6 weeks and 12 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start10 Aug 2021
- Primary completion10 Oct 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816474
- Sponsor's protocol ID
- KTO Karatay University Evre
- Status last verified
- Feb 2022
- First submitted
- 11 Mar 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is completed.
Publications
Yilmaz E, Polat U. Online Disease Management Training for Older Adults With Osteoarthritis: A Randomized Controlled Trial. Musculoskeletal Care. 2024 Sep;22(3):e1931. doi: 10.1002/msc.1931.
PubMed 39134868
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training on Disease Management and Phone Counseling Service for Older Patients With Osteoarthritis on Functional Status, Self-Efficacy and Quality of Life
- ClinicalTrials.gov ID
- NCT04816474
- Acronym / sponsor ID
- KTO Karatay University Evre
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, nurse, self-efficacy, quality of life, functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 25 Mar 2021 (actual)
- 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 study will be conducted to determine the difference on functional status, self-efficacy, and quality of life between groups with and without telephone counseling and training on disease management for participants.
Detailed description
When the literature is examined, in patients with osteoarthritis who receive face-to-face training and intermittent telephone counseling; It is observed that the level of self-efficacy, compliance with the disease and quality of life have increased. It is stated that face-to-face training and telephone counseling services provided to participants on disease management will increase the effectiveness of education and as a result; It is thought that participants may have positive outcomes such as expressing their problems more easily, feeling safer by communicating frequently, and developing methods of coping with nurse-patient cooperation. When the studies conducted in our country are examined, while there are studies examining the effect of non-pharmacological interventions such as acupressor, hot-cold application, exercise training, mud pack treatment in patients with osteoarthritis; No study was found in the elderly patient group in which education and telephone counseling were conducted. The results of the research are thought to be beneficial in managing the disease in addition to in addition to pharmacological treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and Phone Counseling Service | Experimental | Behavioral: Online education and Phone Counseling ServicePatients in this group will be trained online for 6 weeks. After the online training is over, a telephone consultation service will be provided once a week for 6 weeks. |
| Control | No intervention | –No application will be made to patients in this group for 12 weeks. Pre-test and post-test will be applied. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 and over
- OA was diagnosed by the physician according to the American College of Rheumatology (ARD) criteria,
- Being able to answer research questions
- Individuals who gave their oral and written consent to participate in the study were included.
Key exclusion criteria (9 listed)
- Having a history of malignancy
- Those who score above 5 points from the Visual Analogue Scale
- With a neuro psychiatric illness
- Having vision and hearing problems
- Receiving intraarticular medication (steroid, chondramine, hyaluronic acid) in the last month
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 |
|---|---|---|
| Online education and Phone Counseling ServiceOnline education total of 6 times for 6 weeks. Phone Counseling Service total of 6 times for 6 weeks | Behavioural | Education and Phone Counseling Service |
Primary outcome
Change from baseline in functional status at 6 weeks and 12. weeks.
Time frame: [Baseline, 6 weeks and 12 weeks]
After the training and counseling, the functional status scores of the patients are checked. The Western 45 Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale has undergone several revisions. WOMAC; It consists of three subgroups: pain during various positions and movements, severity of joint stiffness, and difficulty in performing daily life activities. A total of 24 questions (pain 5, joint stiffness 2, physical function 17) and 5-point likert. In the evaluation, the questions are scored between 0 and 4 according to the Likert scale. The first option "no pain" is calculated as 0 points, the last option "very severe pain" is calculated as 4 points. Maximum scores of subgroups; 20 for pain, 8 for joint stiffness and 68 for physical function. The total score for each subgroup is the sum of the scores given to each item. As the scores get higher, symptoms worsen, restriction increases, and general health deteriorates.
1 secondary outcome
Change from baseline in self-efficacy at 6 weeks and 12. weeks.
Time frame: [Baseline, 6 weeks and 12 weeks]
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 7 Apr 2022.
- Derived from this study: PubMed 39134868Yilmaz E, Polat U. Online Disease Management Training for Older Adults With Osteoarthritis: A Randomized Controlled Trial. Musculoskeletal Care. 2024 Sep;22(3):e1931. doi: 10.1002/msc.1931.
- Individual participant dataSharing planned: No. After the research is completed.
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online education and Phone Counseling Service in people with Osteoarthritis, run by KTO Karatay University at 2 sites in Turkey (Türkiye).
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 9 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Change from baseline in functional status at 6 weeks and 12. weeks. (time frame: [Baseline, 6 weeks and 12 weeks]). 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 NCT04816474, which also lists 1 linked publication.
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 7 Apr 2022.