Effect of Education in Rheumatoid Arthritis

NCT04850183 | Completed

• 1 other identifier: 2019/02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aimed to determine the effect of education on disease management on the quality of life, and anxiety and depression levels of women with Rheumatoid Arthritis. The hypotheses of the current study are as below: H0: Education on disease management in women with Rheumatoid Arthritis does not affect the quality of life and anxiety and depression levels. H1: Education on disease management in women with Rheumatoid Arthritis affects the quality of life and anxiety and depression levels. Patients and Methods: The study was conducted with 66 women with Rheumatoid Arthritis (32 intervention, 34 control groups) at the rheumatology clinic and polyclinic of a university hospital between February and October 2019, in the city of Edirne, Turkey. Data were collected with "Patient Information Form", "Rheumatoid Arthritis Quality of Life Scale", "Health Assessment Questionnaire" and "Hospital Anxiety Depression Scale".

Conditions

Rheumatoid Arthritis; Quality of Life; Depression, Anxiety; Nurse's Role

Outcome Measures

Primary Outcomes (1)

• Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month

  The questionnaire consists of 30 questions, each with a score of "yes" = 1 or "no" = 0. The scores ranged from 0 to 30, with high scores showing poor quality of life.

  Patients' quality of life assess at baseline and in the third month.

Secondary Outcomes (2)

• Change from baseline Hospital Anxiety and Depression Scale (HADS) in the third month

  Patients' HADS scores assess at baseline and in the third month.

• Change from baseline Stanford Health Assessment Questionnaire (HAQ) in the third month

  Patients' HAQ score assess at baseline and the third month.

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention group at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. In the 3rd month, all forms were applied again to the patients in the intervention group.

Behavioral: Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis

Control group

NO INTERVENTION

Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the control group at baseline. In the 3rd month, the same forms were applied to the untrained patients in the control group.

Interventions

Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis BEHAVIORAL

The patients in the intervention group participated in a one-to-one training program consisting of a 30-min onset session.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The prevalence of Rheumatoid Arthritis prevalence is three times higher in women than in men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be female
• years of age and older
• Diagnosed with Rheumatoid Arthritis who reached the 2010 American College of Rheumatology (ACR) criterion
• Had a disease period of at least 6 months

You may not qualify if:

• Other serious and chronic mental disorders
• Communication difficulties
• Illiteracy

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Irem Yildiz Cilengiroglu

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: intervention group and control group

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: March 4, 2019
• Primary Completion: March 6, 2020
• Study Completion: June 26, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)