| CTRI Number |
CTRI/2024/04/066100 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying how patients who fail to follow the appointments affect healthcare at a specialized hospital. |
|
Scientific Title of Study
|
Assessment of lost-to follow-up patient on healthcare delivery and outcomes in a tertiary care center. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrindha K V |
| Designation |
Post Graduate |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health information management ,Manipal College of
Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08778761802 |
| Fax |
|
| Email |
vrindha.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshmi B |
| Designation |
Additional Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Dept. of Health Information Management, Manipal College of
Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9880530701 |
| Fax |
|
| Email |
reshmi.b@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Protim Hazarika |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Dept. of Health Information Management, Manipal College of
Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8451012070 |
| Fax |
|
| Email |
partha.hazarika@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education,Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India |
|
|
Primary Sponsor
|
| Name |
Vrindha K V |
| Address |
Department of Health information management , Manipal College of Health Professions , Manipal Academy of Higher Education |
| 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 |
| Vrindha K V |
Kasturba Hospital, Manipal |
Room No:15,Department of Nephrology, Kasturba Hospital,Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
08778761802
vrindha.mchpmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (3) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (4) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Lost-to follow-up patient data, Nephrology- Chronic kidney disease
Doctors, nurses, and patients |
|
| ExclusionCriteria |
| Details |
Nonscheduled or walk in patients
Those who are not directly involved in follow-up care.
Patients with incomplete or missing contact details in the EMR |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improve Patient engagement and enhance healthcare delivery
2.Improved Patient Compliance
3.Quality Improvement initiatives |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
01/05/2024 |
| 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="0"
Months="3"
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
|
For phase 1, electronic medical records data from the MRD and IT department are gathered from the year 2021-2023 recruited based on the inclusion and exclusion criteria. Calculation of the percentage of lost to follow up appointments based on the data collected in the excel format is done. Further collected data is analyzed using Jamovi. For phase 2, In depth interviews will be carried out among the doctors and nurses in the chosen departments. Telephonic interviews will be conducted with patients who lost-to follow-up. In-depth interviews with doctors and nurses will be recorded after getting the prior consent. On the other hand, in case of patient’s interviews, conversation will be recorded, and consent will be taken verbally for the same. Further data would be analyzed using ATLAS-TI/ MAXQDA to identify the impact and barriers that result to patients lost-to follow up. |