Effects of Telehealth Initiative on Lupus Patients

NCT05329831 | Completed

• 1 other identifier: LUPUS-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

SLE is mostly seen in young women and causes significant deformity in patients. In SLE, disease activity, body damage due to disease or treatment, comorbidities, and drugs affect body image negatively. SLE causes changes in the body such as skin rashes, uneven pigmentation, vitiligo, scars, tooth loss, alopecia, increased facial hair, stretch marks, weight gain, fatigue, pain, depression, the unpredictability of exacerbations or lack of independence, which worsens the subjective well-being of patients. can affect in that direction. Subjective well-being (SBL) is the scientific term for happiness, and SLE is thought to have a significant negative impact on SWB.

Conditions

Systemic Lupus Erythematosus

Keywords

Life activities; Pain; Happiness

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  It is a form that includes numbers and is used in grading pain. The intensity of pain felt by the patient is marked on a 10 cm ruler, with painlessness (0: no pain) at one end and the most severe pain possible (10: most severe pain) at the other end.

  12 weeks

Secondary Outcomes (2)

• Life Activity Scale

  12 weeks

• Oxford Happiness Scale Short Form

  12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Patients will be asked to fill out the Introductory Information Form, the Numerical Rating Scale, the Oxford Happiness Scale Short Form, and the Life Activities Scale scales. Then, the educational needs of the patients in the experimental group will be determined. Trainings will be planned individually for each patient according to the needs of the patients. After the patients go to their homes, telehealth will be implemented. Patients included in the experimental group will continue their routine physician appointments and prescriptions. In addition, telehealth education initiative will be made for the patients. Structured training will be applied to the patients once a week for 12 weeks, each training will be 20-40 minutes. The researcher will develop a trusting relationship with the patient and evaluate the patient's compliance with treatment, obstacles to happiness, information needs related to pain management, and difficulties in life activities.

Behavioral: Structured training using telehealth

Control

NO INTERVENTION

No application will be made by the researcher to the patients in the control group. Patients will continue with their prescriptions and physician visit routines. The scales will be administered to the patients in this group at the beginning of the study and at the 4th, 8th, and 12th weeks.

Interventions

Structured training using telehealth BEHAVIORAL

The intervention is based on self-care activities. Self-care states that people have an innate ability to take care of themselves.

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Those between the ages of 18-45,
• Diagnosed with SLE disease
• Those who are in remission of the disease
• Those who do not use biological DMARDs
• Non-smokers
• Those who do not drink alcohol
• Those with low disease activity score,
• Neurological, psychiatric disease and non-malignant,
• Individuals who are literate, able to communicate verbally and agree to participate in the study, among those evaluated and approved by their physicians.

You may not qualify if:

• Having a chronic disease other than SLE
• Having a rheumatological disease other than SLE
• Having a disability to use the phone
• Those with hearing loss or visual impairment,
• Those who have undergone changes in the treatment process and those who practice non-drug therapy during the study will not be included in the study.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Hospital

Konya, 42550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: April 15, 2022
• Study Start: March 15, 2022
• Primary Completion: June 20, 2022
• Study Completion: June 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

TU (1)