| CTRI Number |
CTRI/2024/07/070101 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on diseases involving the skin and the mind in a referral hospital in South India |
|
Scientific Title of Study
|
A prospective observational study on the working pattern of Psychodermatology liaison clinic in a tertiary care hospital in South India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manas Jethani |
| Designation |
Junior Resident, Department of Dermatology, Venereology and Leprosy |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology, Venereology and Leprosy
Room number 21, Smt Sharada Madhav Pai OPD Block
Kasturba Hospital
Kasturba Medical College
Madhav Nagar, Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9571645505 |
| Fax |
|
| Email |
drmanasjethani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Prabhu S |
| Designation |
Professor and HOD, Department of Dermatology, Venereology and Leprosy |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology, Venereology and Leprosy
Room number 21, Smt Sharada Madhav Pai OPD Block
Kasturba Hospital
Kasturba Medical College
Madhav Nagar, Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448910972 |
| Fax |
|
| Email |
drsmithaprabhu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Prabhu S |
| Designation |
Professor and HOD, Department of Dermatology, Venereology and Leprosy |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology, Venereology and Leprosy
Room number 21, Smt Sharada Madhav Pai OPD Block
Kasturba Hospital
Kasturba Medical College
Madhav Nagar, Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448910972 |
| Fax |
|
| Email |
drsmithaprabhu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
Karnataka
PIN - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Manas Jethani |
| Address |
Department of Dermatology, Venereology and Leprosy
Room number 21, Smt Sharada Madhav Pai OPD Block
Kasturba Hospital
Kasturba Medical College
Madhav Nagar, Manipal
Udupi
Karnataka
PIN - 576104 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manas Jethani |
Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, Manipal |
Room number 21, Smt Sharada Madhav Pai OPD Block
Kasturba Hospital,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
Karnataka
PIN - 576104
Udupi
KARNATAKA |
9571645505
drmanasjethani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, (2) ICD-10 Condition: L409||Psoriasis, unspecified, (3) ICD-10 Condition: L408||Other psoriasis, (4) ICD-10 Condition: L430||Hypertrophic lichen planus, (5) ICD-10 Condition: L433||Subacute (active) lichen planus, (6) ICD-10 Condition: L438||Other lichen planus, (7) ICD-10 Condition: L439||Lichen planus, unspecified, (8) ICD-10 Condition: L448||Other specified papulosquamous disorders, (9) ICD-10 Condition: L449||Papulosquamous disorder, unspecified, (10) ICD-10 Condition: L209||Atopic dermatitis, unspecified, (11) ICD-10 Condition: L208||Other atopic dermatitis, (12) ICD-10 Condition: L210||Seborrhea capitis, (13) ICD-10 Condition: L218||Other seborrheic dermatitis, (14) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, (15) ICD-10 Condition: L280||Lichen simplex chronicus, (16) ICD-10 Condition: L281||Prurigo nodularis, (17) ICD-10 Condition: L282||Other prurigo, (18) ICD-10 Condition: L298||Other pruritus, (19) ICD-10 Condition: L299||Pruritus, unspecified, (20) ICD-10 Condition: L308||Other specified dermatitis, (21) ICD-10 Condition: L309||Dermatitis, unspecified, (22) ICD-10 Condition: L700||Acne vulgaris, (23) ICD-10 Condition: L705||Acne excoriee, (24) ICD-10 Condition: L709||Acne, unspecified, (25) ICD-10 Condition: L639||Alopecia areata, unspecified, (26) ICD-10 Condition: L649||Androgenic alopecia, unspecified, (27) ICD-10 Condition: L648||Other androgenic alopecia, (28) ICD-10 Condition: L650||Telogen effluvium, (29) ICD-10 Condition: L651||Anagen effluvium, (30) ICD-10 Condition: L658||Other specified nonscarring hair loss, (31) ICD-10 Condition: L659||Nonscarring hair loss, unspecified, (32) ICD-10 Condition: L745||Focal hyperhidrosis, (33) ICD-10 Condition: L100||Pemphigus vulgaris, (34) ICD-10 Condition: L109||Pemphigus, unspecified, (35) ICD-10 Condition: L120||Bullous pemphigoid, (36) ICD-10 Condition: L501||Idiopathic urticaria, (37) ICD-10 Condition: L500||Allergic urticaria, (38) ICD-10 Condition: L508||Other urticaria, (39) ICD-10 Condition: L509||Urticaria, unspecified, (40) ICD-10 Condition: L80||Vitiligo, (41) ICD-10 Condition: A309||Leprosy, unspecified, (42) ICD-10 Condition: A303||Borderline leprosy, (43) ICD-10 Condition: A304||Borderline lepromatous leprosy, (44) ICD-10 Condition: A305||Lepromatous leprosy, (45) ICD-10 Condition: R208||Other disturbances of skin sensation, (46) ICD-10 Condition: R209||Unspecified disturbances of skin sensation, (47) ICD-10 Condition: L981||Factitial dermatitis, (48) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, (49) ICD-10 Condition: F424||Excoriation (skin-picking) disorder, (50) ICD-10 Condition: F633||Trichotillomania, (51) ICD-10 Condition: L750||Bromhidrosis, (52) ICD-10 Condition: L718||Other rosacea, (53) ICD-10 Condition: L719||Rosacea, unspecified, (54) ICD-10 Condition: L292||Pruritus vulvae, (55) ICD-10 Condition: F452||Hypochondriacal disorders, (56) ICD-10 Condition: F458||Other somatoform disorders, (57) ICD-10 Condition: F450||Somatization disorder, (58) ICD-10 Condition: L293||Anogenital pruritus, unspecified, (59) ICD-10 Condition: L290||Pruritus ani, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group more than or equal to 18 years, who visit the Psychodermatology Liaison Clinic in the Department of Dermatology, Venereology and Leprosy at Kasturba Hospital, Kasturba Medical College, Manipal during the study period, and who give their consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Individuals who are unable to comprehend the questions
2. Patients who do not complete all the three consultations
3. Patients with cognitive impairment/dementia
4. Patients currently on Psychiatric medications |
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
1. To study the psychodermatological disease profile of patients seen at Psychodermatology Liaison Clinic
2. To study the psychotropic medications and psychological interventions given
3. To assess patient satisfaction using the Short Assessment of Patient Satisfaction (SAPS) score |
At first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient follow-up rate, attrition rate and the causes of attrition which are assessed by telephonic interview |
At first follow up visit(1 month after the first visit) |
| Assessment of compliance to dermatological treatment, psychiatric treatment and/or psychological treatment personally at follow up or telephonically for defaulters |
At first follow up visit(1 month after the first visit) |
| Assessment of impact of psychodermatological interventions using Dermatology Life Quality Index (DLQI) |
At first visit and at the first follow up visit(1 month after the first visit) |
| Comparison of the patient profile of the Psychodermatology liaison clinic with previously collected data to look for any changing trends in clinical profile as well as patient satisfaction |
Data taken at first visit and comparative assessment with previously available data to be done at the end of the study period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is a prospective observational study on the working pattern of Psychodermatology liaison clinic in a tertiary care hospital in South India. This study aims to study the working pattern of the Psychodermatology liaison clinic in the Department of Dermatology, Venereology and Leprosy at Kasturba Hospital Manipal with particular focus on the clinical profile, treatment, patient satisfaction and challenges faced. The primary outcome measures will be : 1. To study the psychodermatological disease profile of patients seen at the Psychodermatology Liaison Clinic 2. To study the psychotropic medications and psychological interventions given 3. To assess patient satisfaction using the Short Assessment of Patient Satisfaction (SAPS) score The above will be mainly assessed at the first visit. The secondary outcomes include : 1. Assessment of patient follow-up rate, attrition rate and the causes of attrition which are assessed by telephonic interview - assessed at first follow up visit (1 month after the first visit) 2. Assessment of compliance to dermatological treatment, psychiatric treatment and/or psychological treatment personally at follow up or telephonically for defaulters - assessed at first follow up visit (1 month after the first visit) 3. Assessment of impact of psychodermatological interventions using Dermatology Life Quality Index (DLQI) - assessed at first visit and at the first follow up visit (1 month after the first visit) 4. Comparison of the patient profile of the Psychodermatology liaison clinic with previously collected data to look for any changing trends in clinical profile as well as patient satisfaction - data taken at first visit and comparative assessment with previously available data to be done at the end of the study period
|