| CTRI Number |
CTRI/2024/04/065791 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of HIV-Positive individuals’ Weariness And how it affects their quality of life |
|
Scientific Title of Study
|
A Descriptive Cross sectional study on assessment of fatigue in people living with HIV and it’s impact on the quality of life |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDEEP |
| Designation |
Doctor(Post graduate residents) |
| Affiliation |
Maulana azad medical college |
| Address |
Department of medicine,first floor,BL Taneja block,Maulana azad medical college and Lok Nayak hospital
Central DELHI 110002 India |
| Phone |
9650940387 |
| Fax |
|
| Email |
medicine.sandeep2022@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR S ANURADHA |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of medicine,first floor,BL Taneja block, Maulana azad medical college and Lok Nayak hospital
Central DELHI 110002 India |
| Phone |
9643136268 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR S ANURADHA |
| Designation |
Director Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of medicine,first floor,BL Taneja block,Maulana azad medical college and Lok Nayak hospital
Central DELHI 110002 India |
| Phone |
9643136268 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of medicine,first floor,BL Taneja block, Maulana azad medical college and Lok Nayak hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
Department of medicine,first floor,BL Taneja block, Maulana azad medical college and Lok Nayak hospital |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sandeep |
Maulana azad medical college and lok nayak hospital |
room no 618, ART centre,6th floor ,OPD block, Lok Nayak hospital Central DELHI |
9650940387
medicine.sandeep2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana azad medical college and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Any PLHIV 18 year of age or more. |
|
| ExclusionCriteria |
| Details |
Patient having diagnosed bipolar disorder,schizophrenia,or dementia.
Pregnant women
Patient with chronic illness condition marked by fatigue such as diagnosed renal disease,cancer,multiple sclerosis,heart failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of fatigue in people living with HIV |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Risk factor for fatigue
Effect of fatigue on quality of life |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
29/04/2024 |
| 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 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
|
The epidemic of Human Immunodeficiency Virus (HIV) infection was first recognized in USA in 1980’s and over the course of years is a major global health problem. Since the beginning of the epidemic, 84.2 million [64.0–113.0 million] people have been infected with the HIV virus and about 40.1 million [33.6–48.6 million] people have died of HIV. Globally, 38.4 million [33.9–43.8 million] people were living with HIV at the end of 2021. Fatigue is described as an overwhelming sense of tiredness, lack of energy, inertia, or fragility that increases with activity and reduces the person’s normal capacities. It is a heterogeneous condition of complex and multifactorial etiology, which is often unknown. Fatigue does not kill but it is a common, very disabling and debilitating symptom’. Fatigue is one of the common disabling symptoms among many chronic diseases including HIV infection The prevalence of fatigue reported in international studies range from 33% to 88% in PLHIV, and from 7% to 42% in the general population. Nonetheless, the chronicity of HIV infection post-HAART era and side effects has imposed an additional burden of HIV-related symptoms. The cause of fatigue among people living with HIV is probably multifactorial. Most of the studies focused on the physiological and/or psychological factors. Further, evidence suggests that fatigue is associated with age, gender, malnutrition, insomnia, unemployment, poor income, family burden, depression, social support system, several disease-related factors such as the stage of the disease, anaemia, the use of ART and certain laboratory parameters, as well as with the sociodemographic and psychological factors One of the most significant impacts of fatigue on PLHIV is its effect on their mental health. Many PLHIV report feeling depressed, anxious, or irritable due to their constant fatigue, which can lead to a decrease in their overall quality of life. Hence it is important to assess the prevalence of fatigue in PLHIV and risk factors associated with it. |