The Effect of Nursing Follow-Up by Phone on The Self-Efficacy,Pain,Disease Activity in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. The study sample consisted of 64 individuals, including 32 interventions and 32 comparison groups, who met the inclusion criteria. The research was conducted in a randomized controlled experimental study design. In data collection; 'Personal Information Form', 'Arthritis Self-Efficacy Scale', 'Visual Analog Scale' and 'DAS 28' score was used. Descriptive statistics (mean±sd) for numerical variables and frequency distributions for categorical variables were used to evaluate the data. Individuals in the intervention group participating in the research; 65.6% of them were women and their mean age was 50.12 (±13.200); of the individuals in the comparison group who participated in the study, it was determined that 56.3% of them were female, their mean age was 45.97 (±11.544). There was no difference in self- efficacy, pain, and disease activity in the first evaluation before the nursing follow-up by phone between the individuals in the intervention and comparison group, and as a result of the 24-week nursing follow-up by phone of the individuals in the intervention group after the training, when compared with the individuals in the comparison group who received routine outpatient service; It was noted that there was an increase in self- efficacy, a decrease in pain severity, and a decrease in disease activity. The self-efficacy, pain, and disease activity of individuals with a diagnosis of RA who use biological agents should be monitored regularly, training needs should be met, telenursing counseling practices should be expanded to increase the effectiveness of education and to manage the process more effectively, and arrangements should be made to enable patients to access telenursing counseling.

Detailed Description
-----------------
The study was conducted in a randomized controlled experimental study design with the aim of determining the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. After the power analysis to calculate the sample size of the study, a total of 64 patients were included in each group with 80% power and 5% margin of error assuming that a minimum difference of 2 points was clinically significant in pairwise comparisons made according to VAS pain scores. In the research, patients who applied nursing follow-up by phone formed the intervention group, and patients who only received routine care formed the control group.

Official Title
-----------------
The Effect of Nursing Follow-Up by Phone on the Self-Efficacy, Pain and Disease Activity Level of Individuals Diagnosed With Rheumatoid Arthritis Using Biological Agents

Conditions
-----------------
Tele-nursing

Intervention / Treatment
-----------------
* Behavioral: NURSING FOLLOW-UP BY PHONE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having been diagnosed with rheumatoid arthritis for at least 1 year, To have received at least 3 doses of biologic agent subcutaneously within the DMARD combination treatment option, Not having problems in communicating, Having no mental problems, hearing and vision problems, Being 18 years or older, Being conscious, Being able to communicate by phone, Applying to Sivas Numune Hospital Rheumatology Polyclinic, No planned training by health professionals on RA and biological agent therapy before, Agree to participate in the study. Exclusion Criteria: Losing one's life during the research period, Termination of biological agent treatment for any reason, Leaving the research voluntarily.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was conducted as the randomized controlled experimental trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Data collection tools were applied face to face. Patient education was carried out in the polyclinic. A training booklet was given at the end of the training. Afterwards, patients were called once a week by telephone for 12 weeks. The patients were followed up by the nurse over the phone and counseling was provided to the patients. Patients were able to call the research nurse when needed. Interim evaluation was made at the 12th week. Data collection tools were applied face-to-face in the outpatient clinic. Patients 13-24. Between weeks, 12 more phone calls were made, once a week. The patients were followed up by the nurse by telephone, and the patients continued to receive counseling services. Patients were able to call the research nurse when needed. At the end of the 24th week, the research forms were applied face to face in the outpatient clinic. The research has finished. | Behavioral: NURSING FOLLOW-UP BY PHONE<br>* The training was carried out in the form of individual training and as a single session.The training,which lasted about 30 minutes,was carried out in the training room of the polyclinic with the support of Barco vision.In the training session,lecture,question-answer methods were used and at the end of the training session,a booklet containing the training content was given to the patients.The researcher phoned the patients once a week for 24 weeks,conveyed how they were doing,whether there was anything they wanted to ask or learn,and provided counseling to the patients in line with their needs.The next week's plan was also determined in the phone calls made in the following weeks.Patient follow-ups as stated were continued for 24 weeks.At the 12th and 24th weeks of the telephone nursing follow-up, the patients filled out the scales again.<br>|
| No Intervention: Control Group<br>Individuals meeting the sample specifications were included in the control group in accordance with the order of numbers in the lists created by randomly assigning numbers. Data collection tools were applied face to face. Routine outpatient follow-ups continued. Interim evaluation was made at the 12th week. In the interim evaluation, data collection tools were applied face to face. Then, routine outpatient follow-up between 13 and 24 weeks continued. At the end of the 24th week, data collection tools were applied face to face. The patients were educated in the outpatient clinic. A training booklet was given at the end of the training. The research has been terminated. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis Self-Efficacy Scale | It was developed in the United States in 1989 by Lorig et al. to help individuals cope with their arthritis and to measure their self-efficacy perceptions. There are a total of 20 expressions on the 10-digit visual scale, which has 3 sub-scopes: self-efficacy in pain, self-efficacy in functions, and self-efficacy in other symptoms. Turkish validity and reliability study was carried out by Ünsal and Kaşıkçı in 2006. | It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Arthritis Self-Efficacy scores at the end of the 12th and 24th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analog Scale -VAS | It is used to convert some values that cannot be expressed through numbers into numeric. Pain experienced by the patient during use in RA; Absence of pain is graded between 0 points and severe pain is scored between 10 points (Gift, 1989). | It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Pain Visual Analog scores at the end of the 12th and 24th weeks | 
| DAS-28 (Disease Activity Score 28) | It is a scoring system used to determine rheumatoid arthritis disease activity. The calculation is routinely performed by the physician for all patients by evaluating the number of tender and swollen joints, erythrocyte sedimentation rate, global evaluation of the patient and VAS measurements in a special type calculator. According to the obtained DAS score; DAS 28 ≤2.4 is considered as remission, 2.4-3.6 low disease activity, 3.6-5.5 moderate disease activity, ≥ 5.5 high activity value (Prevoo et al., 1995). | It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline DAS-28 (Disease Activity Score 28) scores at the end of the 12th and 24th weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Biological Agent, Telephone Monitoring, Nursing Practices