Back to resultsEffects of Telehealth Initiative on Lupus Patients
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured training using telehealth
Sponsored by
About this trial
This is an interventional supportive care trial for Systemic Lupus Erythematosus focused on measuring Life activities, Pain, Happiness
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.
Sites / Locations
- Selcuk University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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".
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05329831
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Life activities, Pain, Happiness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Structured training using telehealth
Intervention Description
The intervention is based on self-care activities. Self-care states that people have an innate ability to take care of themselves.
Primary Outcome Measure Information:
Title
Numerical Rating Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Life Activity Scale
Description
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".
Time Frame
12 weeks
Title
Oxford Happiness Scale Short Form
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Selcuk University Hospital
City
Konya
ZIP/Postal Code
42550
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It may be considered later in the research.
Learn more about this trial
Effects of Telehealth Initiative on Lupus Patients
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