Rheumatoid ArthritisNCT05039372
Rheumatoid Arthritis, Planned Behavıor Theory And Nurse Counselıng
A study testing TRAINING AND CONSULTANCY in people with Rheumatoid Arthritis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Ensuring disease management begins with comprehensive education and drug therapy. Symptoms such as deformities, pain and fatigue, which are most common in rheumatoid arthritis patients, seriously affect the daily activities of the patients. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TRAINING AND CONSULTANCY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2022to 30 Jan 2023
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 64 years old
- Diagnosed with Rheumatoid Arthritis at least 6 months ago,
- Can communicate in Turkish and does not have a cognitive problem that prevents communication,
- No neurological or psychiatric disease without malignancy,
- Without heart failure (stages III and IV according to NYHA)
- Not pregnant,
- Able to use a telephone,
- Patients who volunteer to participate in the study will be included in the study.
Who cannot join
- Under 18 years old,
- Newly diagnosed, treated for less than 6 months,
- Having a malignant type of disease,
- Patients who do not volunteer to participate in the study will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Nurse Counselıng Applıed Accordıng To Planned Behavıor Theory On Paın, Fatıgue And Functıonal Status In Patıents Wıth Rheumatoid Arthritis
Ensuring disease management begins with comprehensive education and drug therapy. Symptoms such as deformities, pain and fatigue, which are most common in rheumatoid arthritis patients, seriously affect the daily activities of the patients. In order to improve the quality of life of the patient, it is essential that he receives planned education about his disease and constant follow up it like this helps him manage his disease by providing behavioral changes. There are similar studies on chronic diseases in the literature, and it has been seen to make a positive contribution. Studies have shown that patient education includes only information, counseling or behavioral therapies, and does not necessarily turn into behavior change on its own. Which was developed on the basis of education and human behavior theories, According to The Theory of Planned Behavior it is thought that patients can cope with their illnes, manage their illnesses and show behavioral changes by adapting to the illness with the help of nursing counseling. The importance of patient follow-up has once again come to the fore when it comes to the problems that those with chronic diseases may experience during the pandemic process and the difficulties in finding solutions. Recently, training and follow-up are carried out with remote access in the management of many chronic diseases. Especially in chronic diseases such as rheumatoid arthritis, which affects all systems, the counseling service to be provided to the extent that behavior change can be achieved has become more important. In this direction, it is thought that it will be beneficial in the long term for patients to gain behavioral changes by telephone monitoring after education.
Read the detailed description
Examining the studies in the literature, the effect size between the experimental group and the control group was calculated and it was estimated to be around 0.70. In the experimental and control groups, a total of 68 individuals, including at least 34 individuals in both groups, should be included in the study in order to determine the difference between the groups in the power analysis calculated with 80% power and 0.05 significance. Considering that there would be individuals who could not continue to work or could not be reached afterwards, the number of required to be reached individuals was calculated as 74 individuals. In this study, the sample size was calculated with the GPower program version 3.1.
Type and Time of Research
This research is planned to be conducted as a randomized controlled experimental study.
Application of Research
In the research, the applications to be made to the control and experimental groups are explained separately:
*Control Group Intervention: After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life). Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview. After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for Rheumatoid Arthritis patients will be given.
Experimental Group Initiative: After obtaining written consent from the patients who agreed to participate in the study, they will be asked to continue with their rheumatologist follow-up and their normal lives (hospital routine, daily life).
"Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview. Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training. Mutual contact information will be shared with the patient and it will be stated that he can call during the counseling period (3 months).In line with the theory of planned behavior in patients with Rheumatoid Arthritis counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management. At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TRAINING AND CONSULTANCY
- Keywords
- Planned Behavior Theory
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAINING AND CONSULTANCYBehavioural
TRAINING AND CONSULTANCY
| Study group | Role | What they receive |
|---|---|---|
| training and consultancy | Experimental | "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview. Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training. In line with the theory of planned behavior in patients with rheumatoid arthritis, counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management. At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again. Receives: Behavioral: TRAINING AND CONSULTANCY |
| control | No intervention | After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life). Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview. After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for rheumatoid arthritis patients will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Patient-Reported Fatigue
Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ): It was developed to evaluate the effect of fatigue in different dimensions in patients with rheumatoid arthritis. There are 20 questions in total. Total BRAF-MDQ scores range from 0 to 70. Higher scores indicate higher fatigue.
Measured: 0-3 months
Evaluation of Patient-Reported Pain
McGill Pain Scale Short Form (MAS-SF): The scale provides information about the sensory characteristics, severity and effect of pain. The main component of the scale consists of 15 descriptive adjectives for sensation of pain and is self-rated by the patient according to the level of intensity on a scoring scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Measured: 0-3 months
Assessment of Patient-Reported Functional Status
Stanford Health Assessment Scale (HAQ): The Health Assessment Scale is a functional measurement method that is frequently used to evaluate the functional status of rheumatology patients in their daily lives. The scale consists of 20 items in the form of 8 sections. A high score on the scale indicates functional disability.
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start30 Jan 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
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 Rheumatoid ArthritisStudies 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
- Crossover
- Model description
- experimental randomized controlled
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keriman Aytekin Kanadli, Hasan Kalyoncu University
- Investigators
- Nermin Olgun, professor, Study director, Hasan Kalyoncu University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039372
- Sponsor's protocol ID
- interventional
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanadli KA, Olgun N. Nurse Counseling Based on Planned Behavior Theory in Patients With Rheumatoid Arthritis. Pain Manag Nurs. 2026 Apr;27(2):124-132. doi: 10.1016/j.pmn.2025.08.002. Epub 2026 Mar 17.
PubMed 41850956
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Nurse Counselıng Applıed Accordıng To Planned Behavıor Theory On Paın, Fatıgue And Functıonal Status In Patıents Wıth Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05039372
- Acronym / sponsor ID
- interventional
- Conditions
- Rheumatoid Arthritis
- Keywords
- Planned Behavior Theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 Sep 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.
Ensuring disease management begins with comprehensive education and drug therapy. Symptoms such as deformities, pain and fatigue, which are most common in rheumatoid arthritis patients, seriously affect the daily activities of the patients. In order to improve the quality of life of the patient, it is essential that he receives planned education about his disease and constant follow up it like this helps him manage his disease by providing behavioral changes. There are similar studies on chronic diseases in the literature, and it has been seen to make a positive contribution. Studies have shown that patient education includes only information, counseling or behavioral therapies, and does not necessarily turn into behavior change on its own. Which was developed on the basis of education and human behavior theories, According to The Theory of Planned Behavior it is thought that patients can cope with their illnes, manage their illnesses and show behavioral changes by adapting to the illness with the help of nursing counseling. The importance of patient follow-up has once again come to the fore when it comes to the problems that those with chronic diseases may experience during the pandemic process and the difficulties in finding solutions. Recently, training and follow-up are carried out with remote access in the management of many chronic diseases. Especially in chronic diseases such as rheumatoid arthritis, which affects all systems, the counseling service to be provided to the extent that behavior change can be achieved has become more important. In this direction, it is thought that it will be beneficial in the long term for patients to gain behavioral changes by telephone monitoring after education.
Detailed description
Examining the studies in the literature, the effect size between the experimental group and the control group was calculated and it was estimated to be around 0.70. In the experimental and control groups, a total of 68 individuals, including at least 34 individuals in both groups, should be included in the study in order to determine the difference between the groups in the power analysis calculated with 80% power and 0.05 significance. Considering that there would be individuals who could not continue to work or could not be reached afterwards, the number of required to be reached individuals was calculated as 74 individuals. In this study, the sample size was calculated with the GPower program version 3.1.
Type and Time of Research
This research is planned to be conducted as a randomized controlled experimental study.
Application of Research
In the research, the applications to be made to the control and experimental groups are explained separately:
*Control Group Intervention: After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life). Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview. After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for Rheumatoid Arthritis patients will be given.
Experimental Group Initiative: After obtaining written consent from the patients who agreed to participate in the study, they will be asked to continue with their rheumatologist follow-up and their normal lives (hospital routine, daily life).
"Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview. Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training. Mutual contact information will be shared with the patient and it will be stated that he can call during the counseling period (3 months).In line with the theory of planned behavior in patients with Rheumatoid Arthritis counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management. At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental randomized controlled
| Arm | Type | Receives |
|---|---|---|
| training and consultancy | Experimental | Behavioral: TRAINING AND CONSULTANCY"Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview. Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training. In line with the theory of planned behavior in patients with rheumatoid arthritis, counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management. At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again. |
| control | No intervention | –After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life). Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview. After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for rheumatoid arthritis patients will be given. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between 18 and 64 years old
- Diagnosed with Rheumatoid Arthritis at least 6 months ago,
- Can communicate in Turkish and does not have a cognitive problem that prevents communication,
- No neurological or psychiatric disease without malignancy,
- Without heart failure (stages III and IV according to NYHA)
Key exclusion criteria (4 listed)
- Under 18 years old,
- Newly diagnosed, treated for less than 6 months,
- Having a malignant type of disease,
- Patients who do not volunteer to participate in the study will not be included.
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 |
|---|---|---|
| TRAINING AND CONSULTANCYTRAINING AND CONSULTANCY | Behavioural | training and consultancy |
Primary outcome
Evaluation of Patient-Reported Fatigue
Time frame: 0-3 months
Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ): It was developed to evaluate the effect of fatigue in different dimensions in patients with rheumatoid arthritis. There are 20 questions in total. Total BRAF-MDQ scores range from 0 to 70. Higher scores indicate higher fatigue.
Evaluation of Patient-Reported Pain
Time frame: 0-3 months
McGill Pain Scale Short Form (MAS-SF): The scale provides information about the sensory characteristics, severity and effect of pain. The main component of the scale consists of 15 descriptive adjectives for sensation of pain and is self-rated by the patient according to the level of intensity on a scoring scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Assessment of Patient-Reported Functional Status
Time frame: 0-3 months
Stanford Health Assessment Scale (HAQ): The Health Assessment Scale is a functional measurement method that is frequently used to evaluate the functional status of rheumatology patients in their daily lives. The scale consists of 20 items in the form of 8 sections. A high score on the scale indicates functional disability.
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 3 Apr 2024.
- Derived from this study: PubMed 41850956Kanadli KA, Olgun N. Nurse Counseling Based on Planned Behavior Theory in Patients With Rheumatoid Arthritis. Pain Manag Nurs. 2026 Apr;27(2):124-132. doi: 10.1016/j.pmn.2025.08.002. Epub 2026 Mar 17.
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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.
Nermin Olgun, professor study director
Hasan Kalyoncu University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAINING AND CONSULTANCY in people with Rheumatoid Arthritis, run by Hasan Kalyoncu University at 1 site 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 8 inclusion and 4 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 3 Apr 2024. 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 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?
Evaluation of Patient-Reported Fatigue (time frame: 0-3 months). The study lists 3 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 NCT05039372, 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 3 Apr 2024.