Rheumatoid ArthritisNCT04850183
Effect of Education in Rheumatoid Arthritis
A study testing Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis in people with Rheumatoid Arthritis and Quality of Life, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aimed to determine the effect of education on disease management on the quality of life, and anxiety and depression levels of women with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Quality of Life, Depression, Anxiety
- What is being tested?
- Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2019to 26 Jun 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be female
- 18 years of age and older
- Diagnosed with Rheumatoid Arthritis who reached the 2010 American College of Rheumatology (ACR) criterion
- Had a disease period of at least 6 months
Who cannot join
- Other serious and chronic mental disorders
- Communication difficulties
- Illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Education on Disease Management to Women With Rheumatoid Arthritis on the Quality of Life and Levels of Anxiety and Depression
This randomized controlled study aimed to determine the effect of education on disease management on the quality of life, and anxiety and depression levels of women with Rheumatoid Arthritis.
The hypotheses of the current study are as below:
Read more
H0: Education on disease management in women with Rheumatoid Arthritis does not affect the quality of life and anxiety and depression levels.
H1: Education on disease management in women with Rheumatoid Arthritis affects the quality of life and anxiety and depression levels.
Patients and Methods: The study was conducted with 66 women with Rheumatoid Arthritis (32 intervention, 34 control groups) at the rheumatology clinic and polyclinic of a university hospital between February and October 2019, in the city of Edirne, Turkey. Data were collected with "Patient Information Form", "Rheumatoid Arthritis Quality of Life Scale", "Health Assessment Questionnaire" and "Hospital Anxiety Depression Scale".
Read the detailed description
Study design and participants This pretest and posttest prospective study was conducted as randomized controlled between February 2019 and October 2019 in the outpatient and inpatient clinics of the Department of Rheumatology of a university hospital in Edirne, Turkey.
Two study groups, control (n = 40) and intervention (n = 40) were randomized controlled groups with 80% power analysis and 95% confidence interval. A single-blind technique was used to eliminate any bias. The patients were not informed of the group to which they belonged. The patients were selected using a simple random sampling method and divided into intervention and control groups using the Research Randomizer program. In the intervention group, 40 women with RA were interviewed at baseline (first interview). In the 3rd month (last interview), eight patients were excluded for the following reasons: four did not wish to continue the study, three could not be reached, and one patient did not complete the forms. Therefore, 32 women with RA were finally included in the intervention group. In the control group, 40 patients were interviewed at baseline. In the 3rd month (last interview), seven patients were excluded for the following reasons: four patients did not wish to continue the study and three patients could not be reached. Therefore, 34 women with RA were finally included in the control group. The study included a total of 66 women with RA, including intervention (n= 32) and control (n= 34) groups. Flow chart of data collection for women with RA is presented Figure 1.
Data collection tools Data were collected by The Patient Information Form, Rheumatoid Arthritis Quality of Life Scale, the Health Assessment Questionnaire, and the Hospital Anxiety Depression Scale.
Patient Information Form: Our study was developed by researchers in line with a literature review on the subject. (Bozbas \& Gurer, 2018; Fall et al., 2013; Moghadam et al., 2018; Neto et al., 2009). The form consisted of eight questions about sociodemographic characteristics (age, marital status, education, etc.), clinical diagnosis, treatment of RA, concomitant chronic disease, and deformity affected by arthritis.
Rheumatoid Arthritis Patient Education Booklet: The content of the booklet was prepared by researchers in line with the literature. (arthritis.org; Moghadam et al., 2018; nras.org.uk; Rahim \& Cheng, 2018). The education topics included description, symptoms, and signs of RA, diagnostic methods, treatment choices, information on medications, RA in pregnancy, disease management information, nutritional recommendations, emotional health, and support in daily living.
Data collection Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention and control groups at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. The inpatients were given one-to-one training in the patient's room during quiet periods. The outpatients were trained in the outpatient clinic, as tis was considered a suitable venue. In the 3rd month, all forms were applied again to the patients in the intervention group, and the same forms were applied to the untrained patients in the control group. The application of the forms took approximately 15 min, and the interviews were conducted face-to-face with the patients.
Data analysis Data were analyzed using IBM SPSS 20.0 program. Socio-demographic data were analyzed using the mean, standard deviation, and frequency. The Mann-Whitney U paired-group test was used to compare results that did not show a normal distribution. The Fisher's exact test, Pearson chi-square test, and continuity correction test were used. The Wilcoxon signed-rank test was used for the paired comparisons in the comparison of qualitative data. The significance level was set at p < 0.05.
Ethical considerations A University Research Ethics Committee was confirmed the study protocol, which adhered to the Helsinki Declaration (Approval number: 2018/344). Before taking part in the study, all of the patients signed consent forms. Participants were informed that their personal information and privacy would be protected. Patients who did not want to continue to participate in the study were free to leave the study at any stage.
- Being tested
- Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on disease management on the quality of life, and anxiety and depression about Rheumatoid ArthritisBehavioural
The patients in the intervention group participated in a one-to-one training program consisting of a 30-min onset session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention group at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. In the 3rd month, all forms were applied again to the patients in the intervention group. Receives: Behavioral: Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis |
| Control group | No intervention | Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the control group at baseline. In the 3rd month, the same forms were applied to the untrained patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month
The questionnaire consists of 30 questions, each with a score of "yes" = 1 or "no" = 0. The scores ranged from 0 to 30, with high scores showing poor quality of life.
Measured: Patients' quality of life assess at baseline and in the third month.
Secondary outcomes (2)
Change from baseline Hospital Anxiety and Depression Scale (HADS) in the third month
The HADS includes both anxiety and depression subscales, and consists of 14 items, 7 of which examine depression and 7 of which examine anxiety. Answers are assessed on a four-point likert scale and graded between 0 and 3. The purpose of the scale is not to diagnose but to assess the risk group by checking for anxiety and depression over a short period
Measured: Patients' HADS scores assess at baseline and in the third month.
Change from baseline Stanford Health Assessment Questionnaire (HAQ) in the third month
The HAQ is composed of 20 questions that are divided into eight categories: waking up, moving, feeding, dressing and grooming, hygiene, grip, reach, and tasks. Every question has four possible answers: no challenge (0), some difficulty (1), a lot of difficulty (2), and unable to do (3). the score is computed as an average of eight domains with scores varying from 0 to 3, with a higher score displayed significant impairment.
Measured: Patients' HAQ score assess at baseline and the third month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start4 Mar 2019
- Primary completion6 Mar 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Model description
- intervention group and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Yildiz Cilengiroglu, Trakya University
- Investigators
- Irem Yildiz Cilengiroglu, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850183
- Sponsor's protocol ID
- 2019/02
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Education on Disease Management to Women With Rheumatoid Arthritis on the Quality of Life and Levels of Anxiety and Depression
- ClinicalTrials.gov ID
- NCT04850183
- Acronym / sponsor ID
- 2019/02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 20 Apr 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.
This randomized controlled study aimed to determine the effect of education on disease management on the quality of life, and anxiety and depression levels of women with Rheumatoid Arthritis.
The hypotheses of the current study are as below:
H0: Education on disease management in women with Rheumatoid Arthritis does not affect the quality of life and anxiety and depression levels.
H1: Education on disease management in women with Rheumatoid Arthritis affects the quality of life and anxiety and depression levels.
Patients and Methods: The study was conducted with 66 women with Rheumatoid Arthritis (32 intervention, 34 control groups) at the rheumatology clinic and polyclinic of a university hospital between February and October 2019, in the city of Edirne, Turkey. Data were collected with "Patient Information Form", "Rheumatoid Arthritis Quality of Life Scale", "Health Assessment Questionnaire" and "Hospital Anxiety Depression Scale".
Detailed description
Study design and participants This pretest and posttest prospective study was conducted as randomized controlled between February 2019 and October 2019 in the outpatient and inpatient clinics of the Department of Rheumatology of a university hospital in Edirne, Turkey.
Two study groups, control (n = 40) and intervention (n = 40) were randomized controlled groups with 80% power analysis and 95% confidence interval. A single-blind technique was used to eliminate any bias. The patients were not informed of the group to which they belonged. The patients were selected using a simple random sampling method and divided into intervention and control groups using the Research Randomizer program. In the intervention group, 40 women with RA were interviewed at baseline (first interview). In the 3rd month (last interview), eight patients were excluded for the following reasons: four did not wish to continue the study, three could not be reached, and one patient did not complete the forms. Therefore, 32 women with RA were finally included in the intervention group. In the control group, 40 patients were interviewed at baseline. In the 3rd month (last interview), seven patients were excluded for the following reasons: four patients did not wish to continue the study and three patients could not be reached. Therefore, 34 women with RA were finally included in the control group. The study included a total of 66 women with RA, including intervention (n= 32) and control (n= 34) groups. Flow chart of data collection for women with RA is presented Figure 1.
Data collection tools Data were collected by The Patient Information Form, Rheumatoid Arthritis Quality of Life Scale, the Health Assessment Questionnaire, and the Hospital Anxiety Depression Scale.
Patient Information Form: Our study was developed by researchers in line with a literature review on the subject. (Bozbas \& Gurer, 2018; Fall et al., 2013; Moghadam et al., 2018; Neto et al., 2009). The form consisted of eight questions about sociodemographic characteristics (age, marital status, education, etc.), clinical diagnosis, treatment of RA, concomitant chronic disease, and deformity affected by arthritis.
Rheumatoid Arthritis Patient Education Booklet: The content of the booklet was prepared by researchers in line with the literature. (arthritis.org; Moghadam et al., 2018; nras.org.uk; Rahim \& Cheng, 2018). The education topics included description, symptoms, and signs of RA, diagnostic methods, treatment choices, information on medications, RA in pregnancy, disease management information, nutritional recommendations, emotional health, and support in daily living.
Data collection Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention and control groups at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. The inpatients were given one-to-one training in the patient's room during quiet periods. The outpatients were trained in the outpatient clinic, as tis was considered a suitable venue. In the 3rd month, all forms were applied again to the patients in the intervention group, and the same forms were applied to the untrained patients in the control group. The application of the forms took approximately 15 min, and the interviews were conducted face-to-face with the patients.
Data analysis Data were analyzed using IBM SPSS 20.0 program. Socio-demographic data were analyzed using the mean, standard deviation, and frequency. The Mann-Whitney U paired-group test was used to compare results that did not show a normal distribution. The Fisher's exact test, Pearson chi-square test, and continuity correction test were used. The Wilcoxon signed-rank test was used for the paired comparisons in the comparison of qualitative data. The significance level was set at p < 0.05.
Ethical considerations A University Research Ethics Committee was confirmed the study protocol, which adhered to the Helsinki Declaration (Approval number: 2018/344). Before taking part in the study, all of the patients signed consent forms. Participants were informed that their personal information and privacy would be protected. Patients who did not want to continue to participate in the study were free to leave the study at any stage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Education on disease management on the quality of life, and anxiety and depression about Rheumatoid ArthritisPatients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention group at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. In the 3rd month, all forms were applied again to the patients in the intervention group. |
| Control group | No intervention | –Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the control group at baseline. In the 3rd month, the same forms were applied to the untrained patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be female
- 18 years of age and older
- Diagnosed with Rheumatoid Arthritis who reached the 2010 American College of Rheumatology (ACR) criterion
- Had a disease period of at least 6 months
Key exclusion criteria (3 listed)
- Other serious and chronic mental disorders
- Communication difficulties
- Illiteracy
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 |
|---|---|---|
| Education on disease management on the quality of life, and anxiety and depression about Rheumatoid ArthritisThe patients in the intervention group participated in a one-to-one training program consisting of a 30-min onset session. | Behavioural | Intervention group |
Primary outcome
Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month
Time frame: Patients' quality of life assess at baseline and in the third month.
The questionnaire consists of 30 questions, each with a score of "yes" = 1 or "no" = 0. The scores ranged from 0 to 30, with high scores showing poor quality of life.
2 secondary outcomes
Change from baseline Hospital Anxiety and Depression Scale (HADS) in the third month
Time frame: Patients' HADS scores assess at baseline and in the third month.
Change from baseline Stanford Health Assessment Questionnaire (HAQ) in the third month
Time frame: Patients' HAQ score assess at baseline and the third month.
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 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Irem Yildiz Cilengiroglu principal investigator
Trakya 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 Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis in people with Rheumatoid Arthritis and Quality of Life, run by Trakya 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 4 inclusion and 3 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 20 Apr 2021. 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?
Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month (time frame: Patients' quality of life assess at baseline and in the third month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2021.