| CTRI Number |
CTRI/2024/06/068325 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Does caregiving to stroke patients cause stress among caretakers |
|
Scientific Title of Study
|
A study to analyze the stress among caregivers of acute stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithra K |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar
Chennai TAMIL NADU 600116
Chennai TAMIL NADU 600116 India |
| Phone |
8939043012 |
| Fax |
|
| Email |
pavithra22sai@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Radhika C M |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar,
Chennai ,Tamil Nadu 600116
Chennai TAMIL NADU 600116 India |
| Phone |
9841376961 |
| Fax |
|
| Email |
radhikacm@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Radhika C M |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar,
Chennai ,Tamil Nadu 600116
Chennai TAMIL NADU 600116 India |
| Phone |
9841376961 |
| Fax |
|
| Email |
radhikacm@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pavithra K |
| Address |
2nd floor, Room no- 2.7, Sri Ramachandra Faculty Of Physiotherapy, Sri Ramachandra Institute Of Higher Education and Research, Ramachandra nagar, Porur, Chennai- 600 116 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Pavithra K |
Sri Ramachandra Hospital - In patient |
G block, 1st floor,
Sri Ramachandra Medical college,
Sri Ramachandra Nagar,
Porur,Chennai- 600116 Chennai TAMIL NADU |
8939043012
pavithra22sai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of acute stroke patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with stroke, Comprehending and requiring ADL assistance from their caregivers, MODIFIED RANKIN SCALE score 3-5 .
2.For caregivers: Known Language of caregivers - English and Tamil
Care giver being a family member -father, mother, sister, spouse and above 18 years of age
Caregiver providing care for a stroke patient for at least 6 hours a day
Minimum level of literacy among caregivers. |
|
| ExclusionCriteria |
| Details |
i)Unwillingness to participate
ii)Severe cognitive impairment
iii)Recurrent stroke |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin Scale (MRS) |
On the day of the assessment of patients
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Caregivers Strain Index |
From the day of discharge to post 10 days of discharge |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
17/06/2024 |
| 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="0" 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
|
In India the prevalence of stroke is estimated about 1.8% and 40% of the stroke population continue physical therapy services. The major factors which may influence them to continue rehabilitation includes their economic status, gender, age, residence, need for assistance in their day to day activities. (Bharati B et al.,2021) Moreover these post-stroke patients experience long-term difficulties in terms of physical or functional impairments that leads to disability hence community reintegration and emotional functioning becomes very difficult for these patients. (Norrving B et al.,2018). Due to continuous disability, stroke survivors usually require long-term assistance from their caregivers. The majority of the stroke survivors are taken care by their family members. Furthermore, it was also found that caregivers devote a median of 35 hours per week to care for the patient during initial 12 months following stroke which may be harmful to the caregiver’s health and well-being like their psychological health (eg. stress), thus care giving is linked to higher levels of stress, poor quality of life, physical weariness, anxiety, which may have an impact on care giving Due to its debilitating and chronic nature of the disease, caring for stroke patients often puts a considerable stress on their caregiver’s leading to caregiver strain and significant stress, unfortunately these components have been neglected in stroke patient care . Even though there are evidence to suggest that caregiver stress may have a major impact on the recovery and successful rehabilitation of stroke patients .(Bhavin Manowara et al.,2020). These care givers face several challenges while taking care of stroke patients. No study has been done to identify the individual factors that leads to stress for care givers especially among stroke patients where the need and care of the patients becomes entirely different. Thus we intended to do a study to identify and measure the specific causes for the stress on caregivers during stroke rehabilitation. |