Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04850183 |
| Other study ID # |
2019/02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 4, 2019 |
| Est. completion date |
June 26, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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".
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.
