NCT05039372

Brief Summary

Ensuring disease management begins with comprehensive education and drug therapy. Symptoms such as deformities, pain and fatigue, which are most common in rheumatoid arthritis patients, seriously affect the daily activities of the patients. In order to improve the quality of life of the patient, it is essential that he receives planned education about his disease and constant follow up it like this helps him manage his disease by providing behavioral changes. There are similar studies on chronic diseases in the literature, and it has been seen to make a positive contribution. Studies have shown that patient education includes only information, counseling or behavioral therapies, and does not necessarily turn into behavior change on its own. Which was developed on the basis of education and human behavior theories, According to The Theory of Planned Behavior it is thought that patients can cope with their illnes, manage their illnesses and show behavioral changes by adapting to the illness with the help of nursing counseling. The importance of patient follow-up has once again come to the fore when it comes to the problems that those with chronic diseases may experience during the pandemic process and the difficulties in finding solutions. Recently, training and follow-up are carried out with remote access in the management of many chronic diseases. Especially in chronic diseases such as rheumatoid arthritis, which affects all systems, the counseling service to be provided to the extent that behavior change can be achieved has become more important. In this direction, it is thought that it will be beneficial in the long term for patients to gain behavioral changes by telephone monitoring after education.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

September 2, 2021

Last Update Submit

April 2, 2024

Conditions

Keywords

Planned Behavior Theory

Outcome Measures

Primary Outcomes (3)

  • Evaluation of Patient-Reported Fatigue

    Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ): It was developed to evaluate the effect of fatigue in different dimensions in patients with rheumatoid arthritis. There are 20 questions in total. Total BRAF-MDQ scores range from 0 to 70. Higher scores indicate higher fatigue.

    0-3 months

  • Evaluation of Patient-Reported Pain

    McGill Pain Scale Short Form (MAS-SF): The scale provides information about the sensory characteristics, severity and effect of pain. The main component of the scale consists of 15 descriptive adjectives for sensation of pain and is self-rated by the patient according to the level of intensity on a scoring scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

    0-3 months

  • Assessment of Patient-Reported Functional Status

    Stanford Health Assessment Scale (HAQ): The Health Assessment Scale is a functional measurement method that is frequently used to evaluate the functional status of rheumatology patients in their daily lives. The scale consists of 20 items in the form of 8 sections. A high score on the scale indicates functional disability.

    0-3 months

Study Arms (2)

training and consultancy

EXPERIMENTAL

"Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview. Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training. In line with the theory of planned behavior in patients with rheumatoid arthritis, counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management. At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again.

Behavioral: TRAINING AND CONSULTANCY

control

NO INTERVENTION

After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life). Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview. After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for rheumatoid arthritis patients will be given.

Interventions

TRAINING AND CONSULTANCY

training and consultancy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 64 years old
  • Diagnosed with Rheumatoid Arthritis at least 6 months ago,
  • Can communicate in Turkish and does not have a cognitive problem that prevents communication,
  • No neurological or psychiatric disease without malignancy,
  • Without heart failure (stages III and IV according to NYHA)
  • Not pregnant,
  • Able to use a telephone,
  • Patients who volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Under 18 years old,
  • Newly diagnosed, treated for less than 6 months,
  • Having a malignant type of disease,
  • Patients who do not volunteer to participate in the study will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Uninersity

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nermin Olgun, professor

    Hasan Kalyoncu University Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: experimental randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 9, 2021

Study Start

January 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations