Effects of Telehealth Initiative on Lupus Patients

NCT ID: NCT05329831

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-06-30

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.

Detailed Description

Telehealth has been proposed as a component of patient education for disease management. Telehealth, which is defined as the remote delivery of health services via telecommunication tools including telephone and internet, enables accessible and appropriate health care service and provides communication, support, and monitoring opportunities with patients. Researchers think that a telehealth education initiative can be effective on the pain and life activities of SLE patients and this effect will improve their happiness in a good way. Based on these findings, this study aimed to examine the effects of a specific telephone educational intervention on pain, happiness, and activities of living in patients with SLE. The hypothesis of this study is; is that adapted telehealth education intervention can increase the happiness and life activities of patients with SLE and reduce pain.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Structured training using telehealth

Intervention Type: BEHAVIORAL

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

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Structured training using telehealth

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

In determining the inclusion, exclusion and termination criteria, both the literature and the consultation of a specialist in the field were taken.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Halil Ibrahim Tuna PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Selcuk University Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

LUPUS-1

Identifier Type: -

Identifier Source: org_study_id