| CTRI Number |
CTRI/2025/12/099430 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Effect of a Self-Care Management education on Health Outcomes and Quality of Life in Patients with Lupus (Systemic Lupus Erythematosus) |
|
Scientific Title of Study
|
Effectiveness of ‘evidence-based care bundle about self-care management’ on selected outcomes of patients with systemic lupus erythematosus attending a tertiary care center |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nancy Kurien |
| Designation |
PhD Scholar |
| Affiliation |
College of Nursing |
| Address |
Department of Medical Surgical Nursing,
College of Nursing,
All India Institute of Medical Sciences (AIIMS), Jodhpur,
Room No. 119, First Floor.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829069360 |
| Fax |
|
| Email |
nancyblessen2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Raman Kalia |
| Designation |
DirectorPrincipal |
| Affiliation |
|
| Address |
Office of the Director-Principal,
Saraswati Nursing Institute,
Kurali–Morinda Road, Village Dhianpura,
District Roopnagar, Punjab – 140103, India.
Rupnagar
PUNJAB
140103
India |
| Phone |
9876139830 |
| Fax |
|
| Email |
ramandr_kalia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nancy Kurien |
| Designation |
PhD Scholar |
| Affiliation |
College of Nursing |
| Address |
Department of Medical Surgical Nursing,
College of Nursing,
All India Institute of Medical Sciences (AIIMS), Jodhpur,
Room No. 119, First Floor.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829069360 |
| Fax |
|
| Email |
nancyblessen2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nancy Kurien |
| Address |
Department of Medical Surgical Nursing,
College of Nursing,
All India Institute of Medical Sciences (AIIMS), Jodhpur,
Room No. 119, First Floor,
Jodhpur, Rajasthan – 342005,
India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nancy Kurien |
MathuradasMathur Hospital |
Immunology and Rheumatology departmentNear Central Laboratorysecondfloor.Room number 216
Jodhpur
RAJASTHAN |
09829069360
nancyblessen2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee.Dr. Sampurnanand Medical College,Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M329||Systemic lupus erythematosus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Self-Management Care Bundle with Routine Care |
Participants will receive a structured, patient-friendly educational self-management care bundle in addition to routine standard care. The care bundle focuses on identification of systemic lupus erythematosus flares, strategies to improve quality of life, measures to enhance medication adherence, and self-care management practices to help control disease activity.The intervention will be administered after baseline (pre-test). The total duration of the intervention is 12 weeks, starting from baseline (Week 0) and ending at the post-test assessment (Week 12). It comprises,An initial in-person session at baseline (Week 0),Fortnightly reinforcement sessions of 15 minutes (in-person or telephonic) at Weeks 2, 4, 6, 8 and 10 and a final in-person post-test session at Week 12 |
| Comparator Agent |
notapplicable |
notapplicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 18–60 years with a confirmed diagnosis of systemic lupus erythematosus attending the tertiary care center. Participants willing to provide written informed consent and participate in the study. Participants able to understand and communicate in Hindi or English. |
|
| ExclusionCriteria |
| Details |
Patients with systemic lupus erythematosus currently enrolled in another interventional or observational study. Patients with systemic lupus erythematosus currently hospitalized for severe psychiatric instability. Patients unwilling or unable to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in self-care management and quality of life score among patients with systemic lupus erythematosus measured using a validated questionnaire. |
Time points:Baseline (Week 0, pre-intervention) and at12 weeks (Week 12, post-intervention, immediately after the final session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in medication adherence score among patients with systemic lupus erythematosus. |
Baseline (Week 0 pre-intervention)and at 12 weeks (Week 12, post-intervention, immediately after the final session) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Systemic
lupus erythematosus is a chronic autoimmune disease that requires long term
self care and active patient participation for effective disease control. This
interventional study aims to evaluate the effectiveness of an evidence based
educational self management care bundle on selected outcomes among patients
with systemic lupus erythematosus attending a tertiary care center. The care
bundle includes structured education related to identification of disease
flares medication adherence lifestyle modification quality of life improvement
and self care management practices. Eligible participants will undergo baseline
assessment followed by administration of the educational care bundle in
addition to routine standard care. Post intervention assessment will be
conducted to evaluate changes in self care management and quality of life
outcomes. The study hypothesizes that the educational self management care
bundle will result in significant improvement in self care practices and
related outcomes among patients with systemic lupus erythematosus. |