| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|