| CTRI Number |
CTRI/2022/06/043422 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effectiveness of “Cognitive Training’’ on selected outcome variables among heart failure patients visiting cardiology OPD, Advanced Cardiac Centre, PGIMER, Chandigarh, 2021-23. |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of “Cognitive Training’’ on selected outcome variables among heart failure patients visiting cardiology OPD, Advanced Cardiac Centre, PGIMER, Chandigarh, 2021-23. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman Kumari |
| Designation |
M.Sc. Nursing student |
| Affiliation |
NINE,PGIMER |
| Address |
National Institute of Nursing Education(NINE), PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463244800 |
| Fax |
|
| Email |
Sumanbharwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Dutta |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER |
| Address |
Room no. 120, National Institute of Nursing Education(NINE), PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Dutta |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER |
| Address |
Room no. 120, National Institute of Nursing Education(NINE), PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER, Sector 12, Chandigarh |
| 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 |
| Suman Kumari |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Cardiology OPD, Ground floor, C Block, Advanced Cardiac Centre, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9463244800
Sumanbharwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh(intramural), PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Training |
Cognitive Training package includes an educational guidebook which includes information regarding heart failure, causes, signs and symptoms, early detection of complications, prevention and management, Heart failure related cognitive impairment, its causes, effects, early signs and symptoms, early detection, prevention and management. It also includes Information cum demonstration on mental and physical exercises to enhance cognitive abilities. This package also includes counselling sessions, meditation audio, diet video and telephonic reminders.
Cognitive Training will be given at the time of enrollment of participants, on the 15th day, and on the 30th day after enrollment. Also telephonically reinforcement will be given twice weekly. The duration of each session is 20-30 minutes. After the 12th week, variables will be evaluated.
|
| Comparator Agent |
Control group will be given routine treatment as prescribed by the doctor. |
Control group will be given routine treatment as prescribed by the doctor. Memory, executive functions, attention/concentration, anxiety, self-care in heart failure, health-related quality of life (HQOL), medication adherence, functional capacity and satisfaction level will be assessed at baseline (time of enrollment) and at 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Chronic Heart failure NYHA class II and III
2.LVEF ≤40 %
3.18-60 years of age
4.MOCA Score <26
|
|
| ExclusionCriteria |
| Details |
1.Unstable angina
2.Recent MI
3.End stage organ failure
4.ESRD patient on maintenance hemodialysis
5.Mental health disorders
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cognitive functions (memory, attention/concentration; executive functions) |
Primary outcome will be assessed at baseline and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of anxiety, self-care in heart failure, health-related quality of life (HQOL), medication adherence, functional capacity and satisfaction level. |
The secondary outcome will be assessed at baseline and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
01/07/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All the heart failure patients attending cardiology OPD who met the inclusion criteria will be enrolled in the study. Using a random number table, participants will be randomized into experimental and control group. Written informed consent will be obtained from the participants after informing them about the study and the procedure of data collection at the time of enrolment. At the time of enrolment, baseline information regarding sociodemographic profile, the clinical profile will be obtained and a record analysis of diagnostic test reports, medication card will be done. Along with this baseline assessment of cognitive functions, self-care in heart failure, anxiety, medication adherence, HQOL, functional capacity will be done. Patients of the experimental group will be provided with cognitive training which includes an educational guidebook in their understandable language containing information about disease condition, heart failure-related cognitive impairment, information cum demonstration on mental and physical exercises to improve cognitive abilities and a video on the dietary pattern, counselling session, meditation audio whereas participants of the control group will continue with routine care. Telephonic reinforcement will be provided twice a week up to the completion of the study. Cognitive Training Package will be reinforced among the experimental group which includes diet video, meditation audio, physical and mental exercises. All the participants will be followed up on an OPD basis on the 15th and 30th days after enrolment. On the 12th week, a posttest to assess cognitive functions (memory, attention/concentration, executive functions), self-care in heart failure, anxiety, medication adherence, HQOL, functional capacity and satisfaction with care provided will be conducted among participants of both the groups. |