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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05329831
Enrollment
110
Registered
2022-04-15
Start date
2022-03-15
Completion date
2022-06-30
Last updated
2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Life activities, Pain, Happiness

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.

Interventions

BEHAVIORALStructured 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.

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

randomized controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scale12 weeksIt 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.

Secondary

MeasureTime frameDescription
Life Activity Scale12 weeksThe 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.
Oxford Happiness Scale Short Form12 weeksThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026