Systemic Lupus ErythematosusNCT05329831
Effects of Telehealth Initiative on Lupus Patients
A study testing Structured training using telehealth in people with Systemic Lupus Erythematosus, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Structured training using telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Structured training using telehealth
- Keywords
- Life activities, Pain, Happiness
- Medical subject headings
- Lupus Erythematosus, Systemic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured training using telehealthBehavioural
The intervention is based on self-care activities. Self-care states that people have an innate ability to take care of themselves.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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".
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Mar 2022
- Primary completion20 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Tuna PhD, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329831
- Sponsor's protocol ID
- LUPUS-1
- Status last verified
- Oct 2022
- First submitted
- 3 Feb 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It may be considered later in the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Telehealth Education Intervention Given to Lupus Patients on Pain, Happiness and Life Activities: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05329831
- Acronym / sponsor ID
- LUPUS-1
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Life activities, Pain, Happiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Structured training using telehealthPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured training using telehealthThe intervention is based on self-care activities. Self-care states that people have an innate ability to take care of themselves. | Behavioural | Experimental |
Primary outcome
Numerical Rating Scale
Time frame: 12 weeks
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.
2 secondary outcomes
Life Activity Scale
Time frame: 12 weeks
Oxford Happiness Scale Short Form
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided. It may be considered later in the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured training using telehealth in people with Systemic Lupus Erythematosus, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.