| CTRI Number |
CTRI/2025/01/079403 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To understand how treatment in hemodialysis patients is effected by depression , anxiety stress and self-esteem
|
|
Scientific Title of Study
|
Relationship of depression , anxiety , stress and self esteem on medical
adherence in dialysis patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmith kakade |
| Designation |
Master student |
| Affiliation |
Manipal college of health professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education, Bangalore,
Karnataka
Bangalore KARNATAKA 560017 India |
| Phone |
8155053377 |
| Fax |
|
| Email |
nirmith.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Jeeshma Vijin |
| Designation |
Assistant Professor |
| Affiliation |
jeeshma.vijin@manipal.edu |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education, Bangalore,
Karnataka
Bangalore KARNATAKA 560017 India |
| Phone |
08217723829 |
| Fax |
|
| Email |
jeeshma.vijin@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Jeeshma Vijin |
| Designation |
Assistant Professor |
| Affiliation |
jeeshma.vijin@manipal.edu |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education, Bangalore,
Karnataka
Bangalore KARNATAKA 560017 India |
| Phone |
08217723829 |
| Fax |
|
| Email |
jeeshma.vijin@manipal.edu |
|
|
Source of Monetary or Material Support
|
| No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal
College of Health Professions,Manipal Academy of Higher Education, Bangalore,India 560017, |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal,576104 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nirmith kakade |
Manipal Hospitals, Bangalore |
Department of dialysis, Ground floor, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017 Bangalore KARNATAKA |
8155053377
nirmith.mhsblr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient who have been undergoing haemodialysis for at least 6 months |
|
| ExclusionCriteria |
| Details |
Patient who are undergoing peritoneal dialysis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ) |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DEPRESSION ANXIETY STRESS SCALE 21
Rosenberg self esteem scale |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2025 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In 2018 , the prevalence of chronic dialysis patients was 127 per million people. India has an increasing number of patient who require dialysis due to kidney failure , hence there is a requirement in to understand the what factors effect the treatment adherence for dialysis patient so we can improve treatment efficiency. Adherence is defined by the WHO ,as the degree to which the person behaviour corresponds with the agreed recommendation from a health care provider. Most patient only show a moderate level of adherence to treatment , despite the consequences and health complication . Factors such as low socioeconomic status , lack of education about the illness and importance of adherence , low support from family are prominent in literature . Depression is marked by low mood, lack of pleasure in previously enjoyable activites and fatiguability. Depression is prevalent in dialysis patient , and showed a reduce dietary and medical adherence . Anxiety is the Vague and unpleasant emotion , based on anticipation of some real or imagine situation . Anxiety at lower level , can be beneficially , but chronic anxiety and high level of anxiety can impair functioning. Anxiety can cause many of physical and psychological symptoms ,such as increased heartrate ,sweating , palpitation , restlessness, sleeping difficulties, poor concentration. Stress is a physiological reaction that use mobilizes body to burn resources to meet the requirement of a situation. Stress shows similar symptoms to anxiety , though a key difference is that for stress there needs to a stressor , a situation that leads to stress . Self esteem is the evaluation of the self. High self esteem leads to belief that one is a good person ,vice versa. |