| CTRI Number |
CTRI/2024/05/068188 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
creating and verifying intake form for adults with skin disorders and related psychological issues |
|
Scientific Title of Study
|
Development and Validation of Psychodermatology Proforma for Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam S Mathew |
| Designation |
Mphil trainee |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher education |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions
Manipal Academy of Higher Education
Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9108445892 |
| Fax |
|
| Email |
sonam.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama V |
| Designation |
Assistant Professor -Guide |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of clinical psychology
Manipal College of Health Professions
Manipal Academy if Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739016983 |
| Fax |
|
| Email |
v.anupama@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Anagha S Deshmukh |
| Designation |
Assistant Professor (senior scale) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of clinical psychology
Manipal College of Health Professions
Manipal Academy of Health Professions
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7259619947 |
| Fax |
|
| Email |
anagha.deshmukh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| department of clinical psychology
Manipal college of health Professions
Manipal Academy of Higher Education
Eshwar Nagar, Manipal
pincode- 576104 |
|
|
Primary Sponsor
|
| Name |
Sonam S Mathew |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions, Manipal Academy of Higher Education
Eshwar Nagar, Manipal
pincode- 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Anupama Vijayaraghavan |
Kasturba Hospital |
psychodermatology clinic- department of Dermatology and Venereology
Hebri Road, Madhav Nagar,
Manipal
Pincode-576104
Udupi
KARNATAKA |
9739016983
v.anupama@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Phase I: Selection of expert panel
In the first phase of the study, validation of the proforma will be done by experts fulfilling the following criteria.
Inclusion criteria for Phase I
Consultants from department of dermatology, clinical psychology, and psychiatry.
Consultants must be actively part of the Psychodermatology Liaison Clinic.
Minimum of three years of experience as a consultant in Psychodermatology liaison clinic.
Phase II: recruitment of participants for Pilot study
Individuals 18 years and above
Belonging to any Gender
Diagnosed with at least one psychodermatological condition.
Can converse and comprehend in English, Kannada, Malayalam or Tamil. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase I
Outcome measures
1. Main domains for proforma-
measured by Content Validity Index, scores ranging between 0 to 1.
2. Subdomains for proforma- measured by Content Validity Index, scores ranging between 0 to 1.
3. Placement of Domains in the Proforma- measured by Content Validity Index, scores ranging between 0 to 1.
4. Flow of the proforma- measured by Content Validity index, scores ranging between 0 to 1. |
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Phase II
Outcome measures
1.Duration- measures average
time taken to administer the proforma, measured in minutes.
2. Flow of the proforma- measured by agreement rate on likert scale between 1 to 5.
3. Clarity-measured by agreement rate on likert scale between 1 to 5.
4.Comprehensiveness- measured by agreement rate on likert scale between 1 to 5.
5.Relevance- measured by agreement rate on likert scale between 1 to 5. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
20/06/2024 |
| 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="6"
Days="0" |
|
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
|
The purpose of the study is as follows: 1.Structured Proforma is a crucial assessment tool in the Liaison Clinic as it can be used by Clinical Psychologists and Psychiatrist in assessing patients with psychodermatological conditions. 2. A structured proforma would act as a guideline to elicit important information necessary for assessment and treatment of psychodermatological conditions. 3. A psychodermatological proforma would increase the efficiency in eliciting psychosocial factors of psychodermatological conditions.
The aim of the study is, to develop a comprehensive psychodermatological proforma which evaluates adult patients with psychodermatological conditions. Following are the objective(s) of the study: Primary objective: To develop a comprehensive psychodermatological proforma which evaluates adult patients with psychodermatological conditions. Secondary objective: To validate and assess feasibility of psychodermatological proforma for assessing patients with psychodermatological conditions.
|