| CTRI Number |
CTRI/2024/07/071704 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse Led cognitive enhancement strategy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nurse led cognitive enhancement strategy to improve quality of life of dementia patient. |
|
Scientific Title of Study
|
Effect of Nurse Led Cognitive Enhancement Strategy on level of Cognition, Activities of Daily living (ADL), and Quality of life of patient with dementia at IMS and SUM Hospital, Bhubaneswar, Odisha.
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suchismita Pahantasingh |
| Designation |
Associate Professor |
| Affiliation |
SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University |
| Address |
Room number- 4, Second floor,Department of psychiatric nursing,SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar.
Room number- 4, Second floor,Department of psychiatric nursing,SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
9348197119 |
| Fax |
|
| Email |
suchismitapahantasingh@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SUCHISMITA PAHANTASINGH |
| Designation |
Associate Professor |
| Affiliation |
SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University |
| Address |
Room number- 4, Second floor,Department of psychiatric nursing,SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar.
Room number- 4, Second floor,Department of psychiatric nursing,SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
9348197119 |
| Fax |
|
| Email |
suchismitapahantasingh@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sasmita Das |
| Designation |
Associate Dean |
| Affiliation |
SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University |
| Address |
Room number- 2, Ground floor,Department of Medical surgical nursing,SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar.
Room number- 2, Ground floor,Department of Medical surgical nursing,SUM Nursing College, Faculty of nursing, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
9776645936 |
| Fax |
|
| Email |
das.sasmita2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Psychiatric OPD, IMS and SUM Hospita, k-8, Kalinga nagar,Bhubaneswar,khorda,Orissa, India, pin-751003 |
|
|
Primary Sponsor
|
| Name |
SUCHISMITA PAHANTASINGH |
| Address |
SUM Nursing College, Campus-2, K-8, Kainganagar, Bhubaneswar,
751003
|
| 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 Sasmita Das |
Institute of medical science & SUM Hospital |
Room number-2, Psychiatric OPD, Ground Floor, IMS &
SUM Hospital, K-8, Kalinga nagar, Bhubaneswar, 751003
Khordha
ORISSA |
9776645936
das.sasmita2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IMS & SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, (2) ICD-10 Condition: F01-F09||Mental disorders due to known physiological conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse Led Cognitive Enhancement Strategy |
Nurse Led Cognitive Enhancement Strategy is a non- pharmacological multi-component program which will be provided during specific phases of treatment. The strategy will be given for 8 weeks, one session per week and duration of each session will be 45 minutes through telephonic and video conferencing contact. The treating psychiatrist will referred the case to the researcher after consultation and diagnosis. The researcher will be available in the psychiatric OPD throughout the OPD timings. The data collection will be done in a separate room of OPD in order to provide privacy and comfort. The data collection involved daily identification of all the elderly diagnosed with mild to moderate level of dementia attending psychiatric OPD of IMS & SUM Hospital, Bhubaneswar. Baseline data will be extracted from patient’s interview. After the initial daily baseline data extraction on all the dementia patients who were meeting inclusion criteria will be identified. The purpose of the study will be explained to them and they will be informed that they have the freedom to decide to participate or not to participate in the study. Those who are interested in participating in the study were given the consent form, and their written consent will be obtained. Confidentiality and anonymity of the participants and data will be strictly maintained during the data collection process and throughout the research. There are 8 sessions and who fail to attend minimum of 6 sessions of Nurse Led Cognitive Enhancement strategy will be excluded from the study. Samples will be selected using purposive sampling technique.After the identification they will be assigned to both intervention and control group through Computer generated block randomization.The intervention group will receive Nurse Led Cognitive Enhancement strategy along with the routine treatment whereas the control group will only receive the standard treatment and general counselling. The participant will be blinded.
In first session, all samples of intervention group will receive educational session on dementia.The subsequent sessions will be carried out by some warm up and dep breathing exercises, art &craft activity, reminiscence, orientation, concentration, game and life style modifications on diet and exercises. These 8 sessions will be conducted for 8 weeks. Duration of each session will be 45 minutes. After first session, rest sessions will be carried out through telephonic and video conferencing. Repeated measures after completion of the final sessions at 3 months and 6 months.
This program was developed after consultation with psychiatrist,psychologist and gerentologist, nursing professionals and was validated before use.
|
| Comparator Agent |
Nurse Led Cognitive Enhancement Strategy |
The control group will only receive the standard treatment and general counselling. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All mild to moderate level of dementia patient and must have completed six sessions of planned intervention.
|
|
| ExclusionCriteria |
| Details |
Patient with severe dementia,other psychotic symptoms and those who have undergone similar form of cognitive enhancement programme or therapy or any other trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
cognitiontive function of dementia patient.
|
dementia patient diagnosed with mild to moderate level aged more than 65 years.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Activities of daily living
quality of life |
dementia patient diagnosed with mild to moderate level aged more than 65 years.
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/08/2024 |
| 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="0"
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
|
Primary purpose of the protocol: India, the world’s second most populous country, has experienced a
dramatic demographic transition and potential to have increased number of dementia cases and there is no such curative treatment for this, the researcher has wished to introduce an alternative program i.e Nurse led cognitive enhancement strategy to check its effect on dementia client. Hypothesis: 1.H01: There is no significant difference between post test score of
experimental and control group in terms of cognitive function, activities of daily livings and Quality of life. 2.H02: There is no significant changes in cognitive function, activities of daily living and Quality of life of dementia patient before and after receiving intervention. 3.H04 : There is no significant association between cognitive function, activities of daily living and Quality of life of dementia patient with selected sociodemographic
variables. |