| CTRI Number |
CTRI/2025/05/086274 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
how is the satisfaction rate of patients with Telepsychiatry service vs psychiatry OPD consultation? |
|
Scientific Title of Study
|
Measuring patient satisfaction with Telepsychiatry vs In-person consultation of patients in the department of Psychiatry, KDMCH, Mathura |
| 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 Alice Singh |
| Designation |
Post-graduate Resident |
| Affiliation |
KD Medical College & Research Center |
| Address |
4438, Psychiatry OPD, second floor, K.D. Medical College, Mathura
Mathura
UTTAR PRADESH
281406
India |
| Phone |
8868873033 |
| Fax |
|
| Email |
aliceooo331@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Chauhan |
| Designation |
Associate Professor |
| Affiliation |
KD Medical College & Research Center |
| Address |
psychiatry OPD, second floor, OPD building, K.D. Medical College, Mathura
Mathura
UTTAR PRADESH
281406
India |
| Phone |
9897043859 |
| Fax |
|
| Email |
shwetachauhan29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alice Singh |
| Designation |
Post-graduate Resident |
| Affiliation |
KD Medical College & Research Center |
| Address |
psychiatry OPD, second floor, OPD building, K.D. Medical College, Mathura
Mathura
UTTAR PRADESH
281406
India |
| Phone |
8868873033 |
| Fax |
|
| Email |
aliceooo331@gmail.com |
|
|
Source of Monetary or Material Support
|
| psychiatry OPD, second floor, OPD building, K.D. Medical College, Mathura 281406, India |
|
|
Primary Sponsor
|
| Name |
Dr Alice Singh |
| Address |
psychiatry OPD, second floor, OPD building, K.D. Medical College, Mathura, 281406 |
| Type of Sponsor |
Other [self-sponsored study] |
|
|
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 Alice |
KD Medical College |
psychiatry OPD, second floor, OPD building, K.D. Medical College, Mathura
Mathura
UTTAR PRADESH |
9560669413
aliceooo331@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KDMCHRC, Mathura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
option to chose from telepsychiatry service and In-person OPD service and comparing satisfaction from both using short patient satisfaction questionnaire scale |
at day 30 |
| Comparator Agent |
screening for and comparing the rates of reported Depression and Anxiety using Hospital Anxiety and Depression scale from telepsychiatry service vs In-person OPD at day 1 and subsequent follow ups |
day 1, day 15 and day 30 |
| Intervention |
screening for Depression and Anxiety using Hospital Anxiety and Depression scale and at subsequent follow ups |
first screening at day 1
subsequent screening at day 15 and day 30 |
| Comparator Agent |
using short patient satisfaction questionnaire scale |
comparing the patient satisfaction from telepsychiatry service vs In-person at day 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.) Patients who have given written and informed consent.
2.) Adult patients aged 18 years and above.
3.) Patients who have access to mobile phones.
4.) Patients who are able to handle SMS, WhatsApp and other such media.
5.) Patients who have consented to be recorded, either audio or visual, for authentication of data.
6.) Patients with depression and anxiety disorder as per the International Classification of Diseases-10 (ICD 10) criteria.
|
|
| ExclusionCriteria |
| Details |
1.) Patients who refuse to give consent.
2.) Patients less than 18 years of age.
3.) Patients who do not have access to mobile phones.
4.) Patients who are not able to handle SMS, WhatsApp and other such media.
5.) Patients who have not consented to be recorded, either audio or visual.
6.) Patients who do not fit the criteria of depression and anxiety as per the International Classification of Diseases-10 (ICD 10).
7.) Patients who are actively suicidal, or require immediate hospitalization or emergency management services.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure baseline psychopathology of depression and anxiety using Hospital Anxiety and Depression Scale (HADS) in the patients in the Department of Psychiatry in KDMC, Mathura |
baseline intervention (screening) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the change in patient satisfaction in In-Person OPD vs via Telepsychiatry consultation in patients of Depression & Anxiety disorders at subsequent follow ups (day 14 & day 30) in the Department of Psychiatry in KDMC, Mathura |
follow ups (day 14 & day 30) |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
29/05/2025 |
| 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="1"
Months="0"
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
|
This study will be undertaken in the Department of Psychiatry in Kanti Devi
medical college, hospital and research Center, Mathura.
During the study period, the option of telepsychiatry services or out-patient
services at follow up will be provided to the patients. In these patients, who
consent to be a part of this study, assessment of psychopathology (of
Depression and Anxiety) will be done via Hospital Anxiety and Depression Scale
(HADS) on Day 0, 14 and 30.
Patient satisfaction will be measured via patient satisfaction
questionnaire (PSQ-18) on day 14 and 30.
|