| CTRI Number |
CTRI/2021/01/030693 [Registered on: 22/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile application for reminder] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Mobile application for increasing treatment adherence (Mo MITrA) among patients with psychotic illness |
|
Scientific Title of Study
|
Effectiveness of Mobile application for increasing treatment adherence (Mo MITrA) among patients with psychotic illness: A Randomized controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAISON JACOB |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
College of Nursing, All India Insitute of Medical Sciences,SIJUA, DUMDUMA P.O, Bhubaneswar
SIJUA, DUMDUMA P.O, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
nov8525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JAISON JACOB |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
4th floor, College of Nursing, All India Insitute of Medical Sciences,SIJUA, DUMDUMA P.O, Bhubaneswar
SIJUA, DUMDUMA P.O, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
nov8525@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JAISON JACOB |
| Designation |
Tutor/Clinical Instructor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
4th floor, College of Nursing, All India Insitute of Medical Sciences,SIJUA, DUMDUMA P.O, Bhubaneswar
SIJUA, DUMDUMA P.O, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
nov8525@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institue of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institue of Medical Sciences Bhubaneswar |
| Address |
Sijua
Dumduma PO
Bhubaneswar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| JAISON JACOB |
All India Institue of Medical Sciences, Bhubaneswar |
College of Nursing,
4th floor,
SIJUA, DUMDUMA P.O
Bhubaneswar
Khordha
ORISSA |
9164561321
nov8525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary care givers of psychotic patients |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MO MItra application |
MO Mitra will be a Free app for all users. Version Control will be done to choose the best possible version for the usage. Final Product will be accepted only after content validity and App Testing. It will be developed with Logging facility linked with mobile number to have individual account. The Main features of the App is Profile page (Patient and Care taker details), Treatment details (Drug regime and Follow up details), Health Tips including management of Side effects and diet recommendation.the total duration will be 3-4 months |
| Comparator Agent |
Normal Routine Discharge Protocol |
Normal Routine Discharge protocol about the use of medication regime and about follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who are clinically diagnosed as mentally ill suffering from psychiatricillness like Schizophrenia, Schizoaffective, BPAD, Schizophreniform, Depression with psychotic symptoms, Mania with psychotic symptoms, Depression & mania
2. Patients who don’t have optimal/maximum level of medication adherence
3. Patients/Primary care givers who is using smart phone with internet connection
4. Patients/Primary care givers who know understand Odia or who can read basic English.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Acute Psychotic disorders
2. Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Medication adherance level |
0, 30,60, 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life of caregivers |
0 and 90 days |
Severity of Psychiatric illness
|
at 0 and at followups |
Factors affecting Non-adherence
|
for non patient with non compliance |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/04/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Psychotic illnesses have a devastating effect on the lives of the patient and their caregivers. People with these disorders are prone to a substantially high risk of relapse. Managing and controlling psychotic relapse is an important aspect of the psychiatric treatment regimen. Mobile applications have been proved to be successful in many chronic medical disorders and have a significant impact on improving the quality of life of patients and caregivers. Effective relapse prevention will improve overall clinical outcomes and residual symptoms. Effective relapse prevention will inevitably reduce hospitalization costs. |