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

May 8, 2023 updated by: Done Gunay, Cumhuriyet University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sivas, Turkey
        • Döne Günay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
No Intervention: Control Group
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
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.
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
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).
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)
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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Investigators

  • Study Director: Hatice Tel Aydın, Professor, Cumhuriyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-06/38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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