Relationship between caregiver burden and fatigue in participants with stroke
- Conditions
- Cerebral infarction,
- Registration Number
- CTRI/2023/11/059977
- Lead Sponsor
- Ashveya Joylin Dias
- Brief Summary
This study is an observational cross-sectional design. Permission to use Fatigue Severity Scale and Zarit Burden Interview scale has been obtained from the respective authors. Approval from the Institutional Research Committee MCHP MAHE and Institutional Ethics Committee Kasturba Hospital Manipal has been obtained. This study will be registered under the Clinical Trial Registry - India. Stroke survivors who are referred to the Department of Physiotherapy Kasturba Hospital Manipal and their caregivers will be screened for Inclusion and Exclusion Criteria. The selected participants will be provided with detailed instructions regarding the study procedure after which a written informed consent will be obtained. Demographic characteristics of the participants (stroke survivors and caregivers) and clinical characteristics will be documented. For assessment of caregiver burden English or Kannada version of the Zarit Caregiver Burden Interview will be administered to the caregivers. They will be asked to read the components and score from 0(never) to 4(nearly always) according to the level of burden they feel. For assessment of fatigue, English or Kannada version of the Fatigue Severity Scale will be administered to assess the level of fatigue. Participants will be asked to read the components in the scale and circle the number from 1 (strongly disagree) to 7 (strongly agree) based on how accurately it reflects their condition in the past one week. The scales will be administered to stroke survivors and caregivers post seven days of admission to the hospital or on the day of discharge in separate rooms to prevent any administration bias and data contamination. Through a telephonic interview, the participants will be reassessed for the caregiver burden and post stroke-fatigue at 1 month and 3-month post discharge. Data collected from stroke survivors and caregiver will be stored appropriately and analyzed to determine the correlation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
- For post-stroke patients 1)Age greater than 18years.
- 3)Post onset stroke duration between two weeks to 2 years.
- 4)Individuals who report fatigue (VAFS greater than and equal to 4) 5)Able to read and comprehend Kannada/English.
- 6)Cognitively sound (MMSE greater than 23) For Caregiver 1)Aged greater than 18 years.
- 4)Participants who can understand simple instructions.
- For post-stroke patients 1)Individuals who also have problems affecting other systems that contribute to fatigue.
- 2)Individuals undergoing immune modulatory drugs.
- 3)Individuals who underwent surgical procedures for stroke.
- 4)Individuals with recurrent stroke.
- 5)Individuals who had pre-existing daily activity impairment before their stroke.
- 2)Individuals taking care of more than one family members with disability.
- 3)Caregivers already having a disability that may influence their level of burden.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Zarit Caregiver Burden Interview 1st: Seven days post-stroke or on the day of discharge | 2nd: 1 month post discharge | 3rd: 3 months post discharge Fatigue Severity Scale 1st: Seven days post-stroke or on the day of discharge | 2nd: 1 month post discharge | 3rd: 3 months post discharge
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kasturba Medical College and Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College and Kasturba Hospital🇮🇳Udupi, KARNATAKA, IndiaAshveya Joylin DiasPrincipal investigator6360290617ashveyajoylin100@gmail.com