Skip to main content
OpenTrials
Completed

NCT Number: NCT05863338

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tele-nursing Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Döne Günay

Sivas, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NURSING FOLLOW-UP BY PHONE

Behavioral

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.

Primary outcomes

  1. Arthritis Self-Efficacy Scale

    Time frame: 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

    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.

Secondary outcomes

  1. Pain Visual Analog Scale -VAS

    Time frame: 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

    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).

  2. DAS-28 (Disease Activity Score 28)

    Time frame: 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

    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).

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 18, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.