| CTRI Number |
CTRI/2025/04/085510 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the effect of Nurse led home care package on selected outcome variables among children with psoriasis and their caregivers attending Dermatology OPD, PGIMER, Chandigarh. |
|
Scientific Title of Study
|
A mixed method study to assess the effect of Nurse led home care package for children with psoriasis and their caregivers on selected outcome variables among children with psoriasis and their caregivers attending Dermatology OPD, PGIMER, Chandigarh (2024-26). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskaan Singla |
| Designation |
M.Sc. nursing 1st year |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 208,National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh .
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7986453248 |
| Fax |
|
| Email |
muskansingla495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Narang |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 306, National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh .
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjli Kalyan |
| Designation |
Tutor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 223, National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh .
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7696028309 |
| Fax |
|
| Email |
geetss2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muskaan Singla |
| Address |
Room no 208,National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Pincode 160012 |
| Type of Sponsor |
Other [Msc Nursing student ] |
|
|
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 |
| Dr Tarun Narang |
Postgraduate Institute of Medical Education and Research |
Dermatology OPD, New OPD Chandigarh, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Pincode 160012
Chandigarh
CHANDIGARH |
9781167097
narangtarun@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L404||Guttate psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led home care package for children with psoriasis and their caregivers. |
The package will be developed in the form of booklet for caregivers and video for children with psoriasis.
Components of package will include :
1 Information about disease condition- Introduction on psoriasis, etiology, signs and symptoms, medical management and prevention of complications.
2 Nutritional management
3 Stress management strategies
4 Importance of Treatment adherence and follow up
5 Lifestyle modifications
6 Self management methods
7 Healthy behavior practices at home.
|
| Comparator Agent |
Routine care |
Routine care that is routine medical management. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with psoriasis aged 6-18 years and their caregivers.
2. Children with psoriasis and their caregivers able to speak and understand English, Hindi and Punjabi.
3. Children with psoriasis and their caregivers willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Children having other dermatological conditions |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life of children with psoriasis and their caregivers |
8 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RELATED TO CHILDREN WITH PSORIASIS :
Severity of psoriasis
Severity of Itch
Treatment adherence
Psychological profile (stress, anxiety & depression)
RELATED TO THEIR CAREGIVERS
Psychological profile (stress, anxiety & depression)
|
8 weeks after intervention |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/07/2025 |
| 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="5"
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
|
The present study will be conducted with objectives 1. To explore the problems faced by children with psoriasis and their caregivers at Dermatology OPD, PGIMER, Chandigarh. 2. To develop Nurse led home care package for children with psoriasis and their caregivers based on the problems reported by them at Dermatology OPD, PGIMER, Chandigarh.3. To implement “Nurse led home care package for children with psoriasis and their caregivers” at Dermatology, PGIMER, Chandigarh. In two phases, Phase 1 is qualitative and phase 2 is quantitative. In quantitative phase , RCT will be done. Tools used will be A. Sociodemographic profile of child and caregiver B. Clinical profile of the child C. Psoriasis Area and Severity Index to assess severity of psoriasis. D. 5 D Pruritus scale to assess severity of itch. E. Medication Adherence Rating Scale to assess treatment adherence. F. Children’s Dermatology Life Quality Index to assess child’s quality of life G. Family Dermatology Life Quality Index to assess caregiver’s quality of life H. DASS-Y to assess child’s stress, anxiety and depression level. I. DASS-21 to assess caregiver’s stress, anxiety and depression level. Intervention to experimental group will be implemented and post 8 weeks of intervention endline assessment will be done. The study aims at improving the Quality of LIfe of children with psoriasis as well as their caregivers in experimental group. |