| CTRI Number |
CTRI/2026/03/106481 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A Caregiver Educational Program for Stroke Survivors with Swallowing Difficulties. |
|
Scientific Title of Study
|
Development and Feasibility Evaluation of an Educational Module for Caregivers of Individuals with Post-Stroke Dysphagia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha Kamath |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8748939163 |
| Fax |
|
| Email |
anusha2.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devadas |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Kamath |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal College of health professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8748939163 |
| Fax |
|
| Email |
anusha2.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka 576104, India. |
|
|
Primary Sponsor
|
| Name |
Anusha Kamath |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, Karnataka 576104, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Anusha Kamath |
Kasturba Hospital |
Dhanvantari ward, Department of Neurology, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
8748939163
anusha2.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INTSITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caregiver Education Program for Dysphagia Management |
The caregivers will be provided with an educational module on dysphagia management delivered by the primary researcher solely in a printed pamphlet format. No videos or multimedia materials will be used in the study. The module will be tailored to the patient’s current Functional Oral Intake Scale (FOIS) level. As patients progress to higher FOIS levels, caregivers will receive guidance relevant to the current, preceding, and subsequent levels to facilitate safe transitions in feeding. The patients will continue to receive standard care. The educational intervention will commence at baseline during hospitalization and continue until discharge. The duration of the intervention will vary among participants based on individual recovery and clinical progress. Caregivers will be contacted only during scheduled routine follow-up visits for dysphagia management. No additional visits or procedures will be required, thereby minimizing any additional burden. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for Caregivers
1. Informal Primary caregivers
2. Both genders, aged 18 years and above
3. Able to speak and read Kannada
Inclusion criteria for patients
1. Post-ischemic stroke patients diagnosed with
dysphagia
2. Patients at level 2 through level 6 on the
Functional Oral Intake Scale (FOIS), indicating tube dependence with minimal
attempts of food or liquid
3. Medically Stable patients |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for caregivers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Current caregiving practices in dysphagia management questionnaire, Feasibility of
Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention
Appropriateness Measure (IAM)
2. Intervention adherence and incidence of adverse events (aspiration pneumonia, rehospitalization, choking, and swallowing function) |
Baseline (T1): After recruitment and before the educational intervention during hospitalization. The Current Caregiving Practice Questionnaire will be administered.
Follow-up (T2): At 4 weeks after hospital discharge. The Current Caregiving Practices in Dysphagia Management Questionnaire, Functional Independence Measure (FIM), Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), intervention adherence, and adverse events will be assessed. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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)
|
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
|
Stroke often leads to swallowing difficulties, which can cause serious problems such as choking, pneumonia, poor nutrition, and reduced quality of life. After discharge from the hospital, family members usually become the main caregivers and are responsible for preparing food, supervising meals, and following swallowing safety recommendations. However, many caregivers have limited knowledge and support in managing swallowing difficulties, especially in India, where formal care services are limited, and meals are home-prepared. This study aims to develop and evaluate the feasibility of an educational program for caregivers of stroke survivors with swallowing difficulties. The program will provide caregivers with practical information and strategies to safely manage feeding and reduce swallowing-related complications. Findings from this study are expected to help improve caregiver knowledge, confidence, and care practices, and support safer swallowing management for stroke survivors in community settings.
|