| CTRI Number |
CTRI/2018/11/016483 [Registered on: 30/11/2018] Trial Registered Prospectively |
| Last Modified On: |
15/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Stroke Care in India |
|
Scientific Title of Study
|
The National Institute for Health Research Global Health Research Group on improving stroke care in India at The University of Central Lancashire. |
| Trial Acronym |
IMPROVISE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
Professor and Head, Department of Neurology |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Christian Medical College and Hospital Brown Road, Ludhiana
Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
01161-2220850 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
Professor and Head, Department of Neurology |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Christian Medical College and Hospital Brown Road, Ludhiana
Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
01161-2220850 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
Professor and Head, Department of Neurology |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Christian Medical College and Hospital Brown Road, Ludhiana
Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
01161-2220850 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Health Research. United Kingdom |
|
|
Primary Sponsor
|
| Name |
National Institute for Health Research |
| Address |
Room 132, Richmond House, 79 Whitehall, London. SW1A 2NS |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MV Padma |
All India Institute of Medical Sciences |
Department of Neurology, All India Institute of Medical Sciences. Ansari Nagar, New Delhi 110029
North East
DELHI |
01126594794
vasanthapadma123@gmail.com |
| Dr Jeyaraj D Pandian |
Christian Medical College and Hospital |
Department of Neurology, Christian Medical College & Hospital. Brown Road, Ludhiana,141008
Ludhiana
PUNJAB |
01612220850
jeyarajpandian@hotmail.com |
| Dr PN Sylaja |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Department Of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology. Trivandrum, Kerala.695011
Thiruvananthapuram
KERALA |
0471-2443152
sylajapn@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Christian Medical College & Hospital |
Approved |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Approved |
| The George Institute Ethics Committee, George Institute for Global Health India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1st Care bundle: Swallowing assessment and management of swallowing problems.
2nd Care bundle is Monitoring and management of Neurological and Physiological signs.
3rd Care bundle is education and training of relatives in supporting acute stroke care. |
The Implementation Packages will establish a series of three care bundles for patients (assessment and management of swallowing problems, monitoring and management of neurological and physiological signs, and the education and training of relatives in supporting acute stroke care). These implementation packages will be introduced to all patients and form part of usual care, therefore there will be no comparator agent, just baseline measures prior to operationalising the implementation. The exact content and format of the care bundles will be informed by guidelines, rapid evidence synthesis (where required, for example different approaches to measuring dehydration), implementation frameworks and consensus of key stakeholders.Each care bundle will be cumulative, i.e. centres will not stop implementing the first care bundle when they implement care bundle two and so on. 3 months of implementation of each care bundle and 2 months of data collection. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged ≥18 years,
2. A clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation)
3. Neurological deficit on presentation.
4. Present in the stroke unit during periods of data collection.
|
|
| ExclusionCriteria |
| Details |
1. Planned immediate transfer from the Emergency Department (ED)
2. Transient ischaemic attack (TIA) or those admitted only for investigation
3. Consent could not be obtained
4. Unable to follow the patient up according to the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of eligible patients and carers
2. Willingness of participants to be recruited
3.Fidelity to the stepped care bundles
4. Follow-up and attrition rates
5. Availability of data
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of hospital stay
Discharge status
Discharge destination
Health related Quality of Life (EQ-5D and WHOQOL-BREF)
Pneumonia
Proportion of patients with dysphagia
Proportion of patients with END
Proportion of patients with abnormal physiological values
POC tests for hydration compared to osmolality
serious adverse event (SAE)
drop-outs and losses to follow up
Barthel Index of ADL
Patient PHQ-9 and GAD-7 |
3months |
|
|
Target Sample Size
|
Total Sample Size="880"
Sample Size from India="880"
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)
|
01/12/2018 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The aim of the study is to develop and explore the feasibility of delivering a series of nursing care bundles focused on assessment and management of hydration and swallowing, neurological monitoring and education and training of relatives in acute stroke.
Whilst this research will work with India’s current stroke services and systems, it will have the potential to support system change and through implementing research findings in practice. |