| CTRI Number |
CTRI/2025/02/079896 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Training Programs for Stroke Caregivers: Evaluating the Effectiveness of a New Critical Care Pathway on Stroke Recovery Outcomes. |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of newly developed P.W. Critical Care Pathway for stroke patients (PWCCPS) as against the London Stroke Careers Training Course for care givers regards to improvement of (FAST) outcome RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha Wankhede |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Community Health Nursing, Room Number 2, Srimati Radhikabai Meghe Memorial College Of Nursing, Datta Meghe Institute of Higher Education and Research,Sawangi, Meghe, Wardha, India, 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9730870118 |
| Fax |
|
| Email |
pratibhawankhede22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Srimati Radhikabai Meghe Memorial College Of Nursing, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9730870118 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Srimati Radhikabai Meghe Memorial College Of Nursing, Datta Meghe Institute of Higher Education and Research
MAHARASHTRA
442001
India |
| Phone |
9730870118 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Srimati Radhikabai Meghe Memorial College Of Nursing, Datta Meghe Institute of Higher Education and Research, Wardha, IND, 442001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Pratibha Wankhede |
Datta Meghe Institute of Higher Education and Research |
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, India, Room Number 44
Wardha
MAHARASHTRA |
9730870118
pratibhawankhede22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregiver of the stroke patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
London Stroke Carers Training Course. |
The London Stroke Carers Training Course is a program designed to educate caregivers on managing stroke patients, including essential stroke care, rehabilitation techniques, and daily activities. It is delivered through workshops, online modules, or printed materials, with ongoing support provided. The program duration is 1 month, with each session lasting 30 minutes. |
| Intervention |
P.W. Critical Care Pathway for Stroke Patients (PWCCPS). |
The PW Critical Care Pathway for Stroke Patients (PWCCPS) is a structured care plan designed to enhance stroke recovery by focusing on improving FAST outcomes. Caregivers will undergo training sessions and receive follow-up consultations to ensure proper implementation. The program duration is 1 month, with each session lasting 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
This study will include adult stroke patients aged 18 years and above who have been diagnosed within the last 72 hours and exhibit signs of facial drooping, arm weakness, or speech difficulty as assessed by the Cincinnati Pre-hospital Stroke Scale (CPSS). The primary caregivers of these patients, who have been actively involved in daily care for at least one month and are willing to participate in the training and follow-up assessments, will also be included. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include patients with a history of prior strokes, significant comorbidities, severe cognitive impairments, or those enrolled in conflicting clinical trials. Caregivers who are professionally trained in stroke care, have substantial prior caregiving experience, or have severe health conditions preventing participation will also be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is the improvement in stroke recovery, specifically focusing on the FAST (Facial drooping, Arm weakness, Speech difficulty, and Timely activities of daily living) components. These outcomes will be measured using the Cincinnati Pre-hospital Stroke Scale (CPSS). The effectiveness of the newly developed PW Critical Care Pathway will be compared with the London Stroke Carers Training Course to determine which intervention results in better stroke recovery. |
The primary outcome will be assessed at three specific time points: at baseline (before the intervention), at 4 weeks, and at 8 weeks post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes include the evaluation of physical, mental, and social parameters of stroke patients, assessed using the Barthel Index for daily living activities and the WHO Quality of Life Scale. These outcomes will compare the effectiveness of the P.W. Critical Care Pathway and the London Stroke Carers Training Course in improving overall well-being and functional independence of stroke patients. Additionally, the motor function of patients will be assessed using the RACE (Rapid Arterial oCclusion Evaluation) scale, with comparisons made between the two intervention groups. |
Secondary outcomes will be assessed at baseline, immediately post-intervention (4-6 weeks after baseline), and at a 3-month follow-up. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Yet Recruiting |
| 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
|
This randomized controlled trial aims to evaluate the comparative efficacy of the newly developed P.W. Critical Care Pathway for stroke patients (PWCCPS) against the London Stroke Carers Training Course. The study focuses on improving stroke recovery outcomes, specifically FAST (Facial drooping, Arm weakness, Speech difficulty, and Timely activities of daily living) outcomes. Stroke patients and their primary caregivers will be enrolled, with assessments conducted at baseline, immediately after the intervention, and at a 3-month follow-up. The study will also assess the impact of these interventions on the patients’ physical, mental, and social well-being using standardized scales, including the Barthel Index, WHO Quality of Life Scale, and RACE scale. The findings will provide insights into the effectiveness of these care pathways in enhancing stroke recovery and overall quality of life. |