| CTRI Number |
CTRI/2024/09/073775 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed method study |
| Study Design |
Other |
|
Public Title of Study
|
A mixed-method study to find out the barriers and challenges related to patients not following up on their medical care and to learn about the patterns of healthcare usage and cost among hypertension patients |
|
Scientific Title of Study
|
Barriers and Challenges of Loss to follow up, the healthcare utilization pattern, and healthcare expenditure among patients seeking treatment for hypertension at a tertiary care hospital A Mixed Method Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raksha Kamath |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Health Information Management. Manipal College of Health Professions. MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7349744860 |
| Fax |
|
| Email |
raksha2.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Reshmi |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Health Information Management. Manipal College of Health Professions. MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880530701 |
| Fax |
|
| Email |
reshmi.b@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Reshmi |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Health Information Management. Manipal College of Health Professions. MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880530701 |
| Fax |
|
| Email |
reshmi.b@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room No 512. Department of Health Information Management. Manipal College of Health Professions, MAHE Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE Manipal, Udupi, Karnataka, India, 576104 |
| Type of Sponsor |
Private 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 B Reshmi |
Manipal College of Health Professions |
Room No 512. Department of Health Information Management. Manipal College of Health Professions, MAHE Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA |
9880530701
reshmi.b@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who are diagnosed with hypertension and are on medical management
2) Patients above 18 years of age
3) Patients who are lost to follow- up for the treatment
4) Physicians, Nurses, Medical Social workers, Allied health professionals |
|
| ExclusionCriteria |
| Details |
1) Patients who are not consenting to participate in the study
2) Administrative staffs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge about the barriers, challenges, and reasons for patients being non adherent to treatment. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge about the barriers, reasons, trends, demographic factors, and perceived impact on patient’s lost to follow-up from healthcare providers perspectives. |
3months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2025 |
| 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="3"
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
|
Keeping regular appointments is a key indicator of patient
engagement in medical care. Patients miss their regular medical appointments;
in order to prevent complications, it is essential to understand the patient
factors associated with being lost to follow up for treatment regimen.
Understanding the viewpoint of healthcare providers regarding the barriers and
challenges that patient face when following up will also help to determine the
overall burden of lost to follow up on medical care and treatment.
Understanding the associated between lost to follow up
status, the healthcare utilization, and the healthcare expenditure,
specifically focusing on the likelihood of seeking emergency care or
hospitalization due to complications arising among patients with hypertension
will help in knowing the burden of lost to follow up on medical care. |