Clinical trial NCT05863338: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tele-nursing
Keywords: Rheumatoid Arthritis
Biological Agent
Telephone Monitoring
Nursing Practices
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as the randomized controlled experimental trial.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Arthritis Self-Efficacy Scale
timeFrame: 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 outcomes:
measure: Pain Visual Analog Scale -VAS
timeFrame: 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
measure: DAS-28 (Disease Activity Score 28)
timeFrame: 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
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Döne Günay
Study officials:
affiliation: Cumhuriyet University
name: Hatice Tel Aydın, Professor
role: STUDY_DIRECTOR
References:
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