Effects of Telehealth Initiative on Lupus Patients

Determining the Effect of Telehealth Education Intervention Given to Lupus Patients on Pain, Happiness and Life Activities: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Behavioral: Structured training using telehealth

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42550
    • Selcuk University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The intervention is based on self-care activities. Self-care states that people have an innate ability to take care of themselves.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Activity Scale	The index identifies activities aimed at providing the basic requirements necessary for the maintenance of life. The ADL index consists of a total of six questions containing information about bathing, dressing, toilet, movement, excretion and feeding activities. The individual is evaluated by giving 3 points if he/she does the activities of daily living independently, 2 points if he/she does it with help, and 1 point if he/she cannot do it at all. In the ADL index, 0-6 points are evaluated as dependent, 7-12 points as "semi-dependent", and 13-18 points as "independent".	12 weeks
Oxford Happiness Scale Short Form	The scale is a 7-item 5-point Likert type (1-Strongly Disagree, 5-Totally Agree) self-report scale. The highest score that can be obtained on the scale is 35, and the lowest score is 7. A high score indicates that subjective well-being is high.	12 weeks

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Happiness; Life activities
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: LUPUS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It may be considered later in the research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No