Clinical trial NCT05329831: Effects of Telehealth Initiative on Lupus Patients
Official title: Determining the Effect of Telehealth Education Intervention Given to Lupus Patients on Pain, Happiness and Life Activities: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Life activities
Pain
Happiness
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Life Activity Scale
timeFrame: 12 weeks
measure: Oxford Happiness Scale Short Form
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Hospital
Study officials:
References: