| CTRI Number |
CTRI/2024/02/062812 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [multi sensory therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to asses the effect of therapeutic activity on old age persons with Dementia |
|
Scientific Title of Study
|
Impact of Modified-Sonas Programme on Cognition, Communication, And Psychological Wellbeing of Older Persons Having Dementia in Selected Northern States of 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 |
Gaurav Kohli |
| Designation |
Ph.D Scholar |
| Affiliation |
Chitkara University |
| Address |
Chitkara School of Health Sciences, Chitkara University, Punjab, India.
Chitkara School of Health Sciences, Galileo Block, Chitkara University, Punjab, India.
Patiala
PUNJAB
140401
India |
| Phone |
9878521745 |
| Fax |
|
| Email |
gauravkohli78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Kohli |
| Designation |
Ph.D Scholar |
| Affiliation |
Chitkara University |
| Address |
Chitkara School of Health Sciences, Chitkara University, Punjab
Chitkara School of Health Sciences, Chitkara University, Punjab
Patiala
PUNJAB
140401
India |
| Phone |
9878521745 |
| Fax |
|
| Email |
gauravkohli78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Kohli |
| Designation |
Ph.D Scholar |
| Affiliation |
chitkara University |
| Address |
Chitkara School of Health Sciences, Chitkara University, Punjab
Chitkara School of Health Sciences, Chitkara University, Punjab
Patiala
PUNJAB
140401
India |
| Phone |
9878521745 |
| Fax |
|
| Email |
gauravkohli78@gmail.com |
|
|
Source of Monetary or Material Support
|
| AP Jain Hospital, A P Jain Colony for Hospital Staff, Rajpura, Punjab 140401 |
| Prahlad Clinic, Plot No 348, Sector 6, Panchkula, Haryana - 134109 |
|
|
Primary Sponsor
|
| Name |
Gaurav Kohli |
| Address |
Chitkara School of Health Sciences, Chitkara University, Punjab - 140401 |
| Type of Sponsor |
Other [Self funded ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Manu |
AP Jain Civil Hospital |
Department of neuropsychiatric, AP Jain Civil Hospital, A.P Jain Colony, Rajpura, Punjab - 140401
Patiala
PUNJAB |
9501966684
manugmc@gmail.com |
| Dr Neha |
Prahlad Clinic |
Prahlad Clinic, Plot No 348, Sector 6, Panchkula, Haryana - 134109
Panchkula
HARYANA |
7696774606
nehajaipal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| A.P Jain Civil Hospital, Rajpura, Punjab |
No Objection Certificate |
| Institution Ethics committee Chitkara University Punjab |
Approved |
| Prahlad Clinic, Panchkula, Haryana |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified SONAS-programme |
The Modified - Sonas Programme is a multi-sensory therapy. There will be three sessions of the Modified - Sonas Programme at the interval of 3 days. The common goal of these sessions will be to stop the progression of dementia and strive to improve the condition with stimulation of the senses. The session content will be supported by activating the senses of touch, observing, tasting, smell, and hearing. Each session will be conducted for 30 minutes. |
| Comparator Agent |
Telephonic Interaction |
Telephonic interaction calls will be arranged to ask the wellbeing and show concern to the affected older persons having dementia |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
• Subjects diagnosed with dementia attending the dementia clinics |
|
| ExclusionCriteria |
| Details |
- subjects unable to attend all the sessions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognition, Communication, And Psychological Wellbeing |
Day0 - Pretest (Baseline assessment for cognition, communication and psychological wellbeing)
Day1 - Sonas Programme session-I
Day5 - Sonas Programme session-II
Day9 - Sonas Programme session - III
Day 10 - Posttest assessment of cognition, communication and psychological wellbeing)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
01/03/2024 |
| 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 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 study will help to determine the effect of Modified Sonas Programme on old age persons. Efficacy of Modified Sonas Programme will be tested on the old age persons affected with dementia and will contribute to improve their cognition, communication and quality of life. The researcher was motivated from the existing literature to find out the effect of Modified Sonas programme with desired changed according to the culture and preferences of target population in Indian setting. This study will help to generate an evidence to use this cost effective, less time consuming and easy to practice "Modified Sonas Programme" for the improvement of cognition, communication and psychological wellbeing of older persons with dementia. |