Examining the Efficacy of Personalized Lifestyle Intervention in Individuals With Rheumatoid Arthritis

NCT ID: NCT05759585

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-30

Brief Summary

It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis.

Detailed Description

Rheumatoid arthritis (RA) is defined as a chronic, inflammatory autoimmune disease that can damage both joints and non-articular organs, including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system.

Management of RA requires a multidisciplinary approach, as common risk factors for RA include both modifiable lifestyle-related variables and non-modifiable traits such as genetics and gender. Although there is no definitive cure, it is necessary to optimize physical, emotional, and social health in order to minimize the impact of the disease. At this point, self-management interventions come to the fore.

Since many areas of life are affected in individuals with RA, it is seen that there is a need for combined treatments that address the individual holistically, as suggested by EULAR. Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. There is strong evidence in the literature that Lifestyle intervention is an effective approach to managing the symptoms of many chronic diseases.

The number of studies involving lifestyle interventions in individuals with RA, whose importance is emphasized in the literature, is limited. Therefore, our study was planned to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with RA. Hypotheses:

Conditions

Inflammatory Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Person-centered lifestyle intervention group

Intervention group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study.

Person-centered lifestyle intervention in individuals with rheumatoid arthritis is planned as 2 sessions per week, for a total of 4 weeks.

Group Type: EXPERIMENTAL

person-centered lifestyle intervention

Intervention Type: BEHAVIORAL

Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. This program aims to facilitate the individual's self-development of healthy routines and habits; It includes techniques such as patient education, occupational self-analysis, problem-solving, motivation generation, and implementation of behaviors to prevent and manage disease-related symptoms.

Control group

Control group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study.

For the control group, they will be called twice a week for 4 weeks and inquired about their general condition.

Group Type: EXPERIMENTAL

person-centered lifestyle intervention

Intervention Type: BEHAVIORAL

Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. This program aims to facilitate the individual's self-development of healthy routines and habits; It includes techniques such as patient education, occupational self-analysis, problem-solving, motivation generation, and implementation of behaviors to prevent and manage disease-related symptoms.

Interventions

person-centered lifestyle intervention

Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. This program aims to facilitate the individual's self-development of healthy routines and habits; It includes techniques such as patient education, occupational self-analysis, problem-solving, motivation generation, and implementation of behaviors to prevent and manage disease-related symptoms.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being diagnosed with RA between the ages of 18-65 and meeting the ACR/EULAR diagnostic criteria
• Patients with low to moderate disease activity (DAS28 ≤5.1)
• No pharmacological treatment changes for RA in the last 3 months
• Have not had any surgery in the last 6 months
• Understand and cooperate with testing guidelines
• to be literate

Exclusion Criteria

• Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

SULTAN BASTURK

professional

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TIMUR PIRILDAR, PROF

Role: STUDY_DIRECTOR

Manisa Celal Bayar University

Locations

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

SULTAN BASTURK

Role: CONTACT

fzt.sbasturk@gmail.com

05073689316

GAMZE EKICI CAGLAR, PROF

Role: CONTACT

Facility Contacts

TİMUR PIRILDAR, PROF

Role: primary

bashekimlik@cbu.edu.tr

0(236) 236 0330

Other Identifiers

HU-SBASTURK-001

Identifier Type: -

Identifier Source: org_study_id