| CTRI Number |
CTRI/2019/09/021440 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
21/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep quality, Physical functioning and Rehabilitation needs among stroke patients |
|
Scientific Title of Study
|
Astudy to assess the sleep quality, physical functioning and rehabilitation needs among stroke patients in selected hospitals at Kannur District, Kerala |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SABNA PK |
| Designation |
M.Phil Nursing Student |
| Affiliation |
Manipal College of Nursing, Manipal |
| Address |
Manipal College of Nursing, Manipal
Manipal Academy of Higher Education, Manipal
Lourde college of Nursing, Taliparamba, Kannur, Kerala-670143
Udupi
KARNATAKA
576104
India |
| Phone |
9526058270 |
| Fax |
|
| Email |
sabna.pk66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBaby S Nayak |
| Designation |
Professor & Head, Department of Child Health Nursing & Ph.D coordinator |
| Affiliation |
Manipal College of Nursing, Manipal |
| Address |
Manipal College of Nursing, manipal
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448174791 |
| Fax |
|
| Email |
baby.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ProfMrSenthilkumar T |
| Designation |
Principal |
| Affiliation |
LourdeCollege of Nursing, Taliparamba |
| Address |
Lourde College of Nursing, Talipramba, Kannur
Lourde Hospital, Taliparamba, kannur-670141
Kannur
KERALA
670143
India |
| Phone |
9746457669 |
| Fax |
|
| Email |
ns9605@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, Manipal, Manipal Academy of Higher Education/Research Institution, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing, Manipal, Manipal Academu of Higher Education, Udupi, Karnataka, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MrsBindu K Nursing Superintendent |
AKG MEMORIAL CO-OPERATIVE HOSPITAL |
Talap, Kannur-670002
Kannur
KERALA |
9744696166
bindusreejith9@gmail.com |
| Mrs Lidiya Devasia HR Manager |
Koyili Hospital |
N.H.17,Kannur-670004
Kannur
KERALA |
9048467248
lidiyadevasia@gmail.com |
| MrsRakhi Joseph Director |
Lourde Hospital |
Chiravakku, Taliparamba, Kannur-670141
Kannur
KERALA |
9048088248
rakhijoseph@gmail.com |
| SABNA P K PRINCIPAL INVESTIGATOR |
Manipal College of Nursing, Manipal |
Manipal College of Nursing, Manipal, MAHE, Udupi, Karnataka
Udupi
KARNATAKA |
9526058270
sabna.pk66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| AKG MEMORIAL CO OPERATIVE HOSPITAL |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| KOYILI HOSPITAL |
Approved |
| LOURDE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G459||Transient cerebral ischemic attack, unspecified, (2) ICD-10 Condition: G459||Transient cerebral ischemic attack, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are admitted and discharged from the hospital
with at least 6 months history of stroke diagnosis
with the age of 35 Years and above
record available at hospital
stroke is of minor/moderate severity (score of 1to 15 in NIH Stroke Scale)
|
|
| ExclusionCriteria |
| Details |
patients who have severe communication problems
severe stroke (>15 score in NIH Stroke Scale)
inability to provide consent autonomously.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep Quality, Physical functioning and Rehabilitation needs |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep Quality, Physical functioning and Rehabilitation needs |
one time |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2019 |
| Date of Study Completion (India) |
15/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Statement : A Study to assess the Sleep quality, Physical functioning and Rehabilitation needs among Stroke patients in selected hospitals at Kannur district, Kerala Objectives:The objectives of the study are to identify the sleep quality, physical functioning and rehabilitation needs among stroke patients, find the relationship between sleep quality and physical functioning among stroke patients, explore the perceived barriers and facilitators for meeting the rehabilitation needs among stroke patients. Hypotheses: All hypotheses will be tested at 0.05 level of significance. H1 : There will be a significant relationship between sleep quality and physical functioning among stroke patients. Assumptions: Sleep quality , physical functions and rehabilitation needs of patients with stroke vary, There will be a significant relationship between sleep quality and physical functioning among stroke patients, Rehabilitation need assessment will be helpful to identify perceived barriers and facilitators among stroke patients. Purpose: The purpose of the study is to identify the sleep quality, physical functioning, rehabilitation needs and explore the perceived barriers and facilitators for meeting rehabilitation needs among stroke patients. |