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

Primary Purpose

Tele-nursing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NURSING FOLLOW-UP BY PHONE
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tele-nursing focused on measuring Rheumatoid Arthritis, Biological Agent, Telephone Monitoring, Nursing Practices

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Döne Günay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
May 8, 2023
Last Updated
May 8, 2023
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05863338
Brief Title
The Effect of Nursing Follow-Up by Phone on The Self-Efficacy,Pain,Disease Activity in Rheumatoid Arthritis Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tele-nursing
Keywords
Rheumatoid Arthritis, Biological Agent, Telephone Monitoring, Nursing Practices

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was conducted as the randomized controlled experimental trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NURSING FOLLOW-UP BY PHONE
Intervention Description
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 Outcome Measure Information:
Title
Arthritis Self-Efficacy Scale
Description
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.
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
Secondary Outcome Measure Information:
Title
Pain Visual Analog Scale -VAS
Description
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).
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
Title
DAS-28 (Disease Activity Score 28)
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Tel Aydın, Professor
Organizational Affiliation
Cumhuriyet University
Official's Role
Study Director
Facility Information:
Facility Name
Döne Günay
City
Sivas
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
31871717
Citation
Gronning K, Lim S, Bratas O. Health status and self-management in patients with inflammatory arthritis-A five-year follow-up study after nurse-led patient education. Nurs Open. 2019 Oct 8;7(1):326-333. doi: 10.1002/nop2.394. eCollection 2020 Jan.
Results Reference
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PubMed Identifier
33244621
Citation
Mollard E, Michaud K. Self-Management of Rheumatoid Arthritis: Mobile Applications. Curr Rheumatol Rep. 2020 Nov 26;23(1):2. doi: 10.1007/s11926-020-00968-7.
Results Reference
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PubMed Identifier
28420491
Citation
Piga M, Cangemi I, Mathieu A, Cauli A. Telemedicine for patients with rheumatic diseases: Systematic review and proposal for research agenda. Semin Arthritis Rheum. 2017 Aug;47(1):121-128. doi: 10.1016/j.semarthrit.2017.03.014. Epub 2017 Mar 22.
Results Reference
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PubMed Identifier
23385306
Citation
Primdahl J, Sorensen J, Horn HC, Petersen R, Horslev-Petersen K. Shared care or nursing consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis outpatients with low disease activity--patient outcomes from a 2-year, randomised controlled trial. Ann Rheum Dis. 2014 Feb;73(2):357-64. doi: 10.1136/annrheumdis-2012-202695. Epub 2013 Feb 5.
Results Reference
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PubMed Identifier
25424112
Citation
Ryan S. Psychological effects of living with rheumatoid arthritis. Nurs Stand. 2014 Dec 2;29(13):52-9. doi: 10.7748/ns.29.13.52.e9484.
Results Reference
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PubMed Identifier
32851423
Citation
Uthman I, Almoallim H, Buckley CD, Masri B, Dahou-Makhloufi C, El Dershaby Y, Sunna N, Raza K, Kumar K, Abu-Saad Huijer H, Tashkandi N, Louw I, Adelowo O. Nurse-led care for the management of rheumatoid arthritis: a review of the global literature and proposed strategies for implementation in Africa and the Middle East. Rheumatol Int. 2021 Mar;41(3):529-542. doi: 10.1007/s00296-020-04682-6. Epub 2020 Aug 26.
Results Reference
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PubMed Identifier
31858731
Citation
Zhang L, Cai P, Zhu W. Depression has an impact on disease activity and health-related quality of life in rheumatoid arthritis: A systematic review and meta-analysis. Int J Rheum Dis. 2020 Mar;23(3):285-293. doi: 10.1111/1756-185X.13774. Epub 2019 Dec 19.
Results Reference
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The Effect of Nursing Follow-Up by Phone on The Self-Efficacy,Pain,Disease Activity in Rheumatoid Arthritis Patients

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