| CTRI Number |
CTRI/2025/03/081963 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effectiveness of educational intervention on self-management efficacy and coping among patients with psoriasis.
|
|
Scientific Title of Study
|
Effectiveness of educational intervention on self management efficacy and coping among patients with psoriasis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lini Antony |
| Designation |
II year MSc Nursing Medical Surgical Nursing |
| Affiliation |
KUHS |
| Address |
Government college of nursing
Medical surgical Nursing
Gandhinagar
Kottayam
686008 pin
Government college of nursing
Medical surgical Nursing
Gandhinagar
Kottayam
686008 pin
Kottayam
KERALA
686008
India |
| Phone |
8281719221 |
| Fax |
|
| Email |
liniantony4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kavitha Chandran C |
| Designation |
Assistant Professor |
| Affiliation |
KUHS |
| Address |
Government college of nursing
Medical Surgical Nursing
Gandhinagar
Kottayam
686008 pin
Government college of nursing
Medical Surgical Nursing
Gandhinagar
Kottayam
686008 pin
Kottayam
KERALA
686008
India |
| Phone |
8139005157 |
| Fax |
|
| Email |
preethynair79@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Liny Joseph |
| Designation |
Associate Professor |
| Affiliation |
KUHS |
| Address |
Government college of nursing
Government college of nursing
Medical Surgical Nursing
Gandhinagar
Kottayam
686008 pin
Gandhinagar
Kottayam
686008 pin
Government college of nursing
Medical Surgical Nursing
Gandhinagar
Kottayam
686008 pin
Gandhinagar
Kottayam
686008 pin
Kottayam
KERALA
686008
India |
| Phone |
9447832634 |
| Fax |
|
| Email |
linyjsunny@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Hospital.
Gandhinagar
Kottayam
Pin 686008
This study is self funded by me (Lini Antony) and I do not have any external sources of monetary / material support. |
|
|
Primary Sponsor
|
| Name |
Lini Antony |
| Address |
IInd year MSc Nursing
Medical Surgical Nursing
Government College of Nursing
Kottayam
Kerala
India
Pin-686008 |
| Type of Sponsor |
Other [self budget] |
|
|
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 Ajith Kumar |
Government Medical College Hospital Kottayam |
Out patient department of
Dermatology department
Government Medical College Hospital
Kottayam
Pin 686008
Kottayam
KERALA |
8281719221
liniantony4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government college of nursing kottayam, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational intervention
|
a computer-assisted teaching program given to a group of 3 to 4 patients with psoriasis, aimed at equipping them to engage in actions that help foster their self-management efficacy and coping with psoriasis. This includes a basic understanding of psoriasis, dietary modifications, skin care practices, regular physical activity recommendations. Participants will be provided with a booklet on self-care management of psoriasis and telephonic follow up will be done by the investigator. After 4 weeks post test will conduct for both group in order to identify the effectiveness of educational intervention. The total duration of the study is 6 weeks. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with psoriasis who are above the age of 18 years and able to comprehend Malayalam
|
|
| ExclusionCriteria |
| Details |
Patients with psoriasis who are
having active symptoms of mental illness and on treatment.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome name: Mean change in self-management efficacy score,
time points: 4 weeks
Outcome name: Mean change in coping score, Time points: 4 weeks |
The outcome will be assessed at 4 weeks after the implementation of the education intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the association between self-management efficacy among patients with psoriasis and selected variables.
To identify the association between coping of patients with psoriasis and selected variables.
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
11/03/2025 |
| 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="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a quasi experimental pretest post test control group design. The sampling technique is purposive sampling, to identify the effectiveness of educational intervention on self management efficacy and coping among patients with psoriasis. The study will conduct in OPD of Government Medical College Hospital, Kottayam. The study duration is 6 weeks. The primary outcome is to improve self-management efficacy and coping with psoriasis. The secondary outcomes are to identify the association of self management efficacy with selected variables and to identify the association of coping with selected variables. |