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CTRI Number  CTRI/2024/06/068609 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Examining Apathy and Depression in Stroke survivors. 
Scientific Title of Study   Beyond stroke: A comprehensive assessment of apathy and depression in post 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  Ayisha Afeefah A 
Designation  Student 
Affiliation  Karavali College of Pharmacy, Mangalore 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  7090244644  
Fax    
Email  iam68lupa5678@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manish Kundar 
Designation  Assistant professor 
Affiliation  Karavali College of Pharmacy, Mangalore 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  8105377059  
Fax    
Email  manishkundar6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manish Kundar 
Designation  Assistant professor 
Affiliation  Karavali College of Pharmacy, Mangalore 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  8105377059  
Fax    
Email  manishkundar6@gmail.com  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  Ayisha Afeefah A 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ayisha Afeefah A  Father Muller Medical College Hospital  4th Floor, Unit E, Department of general medicine, Father Muller Medica Hospital, kankanady, Mangalore-575002 Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
7090244644

iam68lupa5678@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Stroke patients who have been admitted to general medicine and neurology departments with or without co-morbidities. 
 
ExclusionCriteria 
Details  Patients who are unresponsive, unconscious and comatose. Patients who are not willing to participate in the study. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of apathy and depression using DAS and DASS questionnaire.  0,15,30 days 
 
Secondary Outcome  
Outcome  TimePoints 
The outcome determines medication adherence in stroke patients using MARS. Assessment of apathy and depression using DAS and DASS questionnaire and to assess the quality of life of post stroke patients using SS-QoL questionnaire. To check for drug interactions and to provide educational information regarding apathy and stroke to stroke patients and their caregivers will help in the better management and early diagnosis.   0, 15, 30 days 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   21/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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 is a neurological condition caused by sudden damage to the central nervous system due to vascular issues like cerebral infarction or hemorrhage. Strokes can result in death or impairments in physical and cognitive functions, along with lasting psychological and social consequences.

Post-stroke, patients may struggle with physical movement, bladder and bowel control, numbness, memory, speech, emotional control, and depression. Reviews indicate that stroke survivors and their caregivers often feel they are inadequately informed about the condition.

Apathy and depression are common in post-stroke patients, significantly impacting their quality of life and rehabilitation. This study aims to screen for apathy and depression using the Dimensional Apathy Scale (DAS) and the Depression, Anxiety, and Stress Scale (DASS) questionnaires. The DASS helps identify the relationship between stress, depression, anxiety, and apathy, providing valuable insights for appropriate interventions.

This study aims to assess post-stroke depression and apathy using the DASS, the Apathy Evaluation Scale (AES), and the SS-QoL (Stroke-Specific Quality of Life) questionnaire. The primary objective of the study is to assess apathy and depression in post-stroke patients using the DAS and DASS questionnaires. The secondary objectives include determining medication adherence in stroke patients using the MARS, assessing the quality of life of post-stroke patients using the SS-QoL questionnaire, providing basic information on apathy and depression to stroke patients and their caregivers through telecommunication, and checking for drug interactions.

 

 
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