| CTRI Number |
CTRI/2023/07/055865 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life and use of healthcare services among Diabetes patients in an urban resettlement colony of Delhi |
|
Scientific Title of Study
|
Quality of life and health care utilization among adults with Type 2 Diabetes Mellitus in an urban resettlement colony of Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaheeda T P |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, 3rd floor, Pathology block, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9497547016 |
| Fax |
|
| Email |
tpshaida@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amod Laxmikant Borle |
| Designation |
Associate Professsor |
| Affiliation |
Maulana Azad medical College |
| Address |
Room no:362, Department of community medicine,3rd floor, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8393935207 |
| Fax |
|
| Email |
dramodborle@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaheeda T P |
| Designation |
Junior Resident |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of Community Medicine, 3rd floor, Pathology block, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002
B
New Delhi
DELHI
110002
India |
| Phone |
9497547016 |
| Fax |
|
| Email |
tpshaida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of community medicine, Maulana Azad Medical College, New delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 |
| 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 SHAHEEDA T P |
Urban Health Centre, Gokalpuri |
Gokalpur, New Delhi, Delhi 110053
New Delhi
DELHI |
9497547016
tpshaida@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAMC |
Approved |
| Maulana Azad Medical College |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged >30 years who are known cases of Type 2 DM
2)Patients diagnosed with Type 2 DM for more than 6 months
3)Patients residing in the study area for more than 6 months |
|
| ExclusionCriteria |
| Details |
• Bedridden patients and severely ill patients who are unable to communicate
• Known cases of psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Mean/median scores of quality-of-life assessments using QOLID score for adults with Type 2 DM using QOLID questionnaire
2)Proportion of utilization of various health care services for Type 2 DM
3)The mean/median number of visits to a healthcare facility during the last 6 months by individuals with Type 2 DM |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)The mean/median amount of health care expenditure per month of diabetes patients
2)Various sources of financing for health care expenditure regarding Type 2 DM
3)Proportion of Type 2 diabetes mellitus patients with catastrophic health expenditure & their mean catastrophic health expenditure |
1 year |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
07/08/2023 |
| 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
|
A community-based cross-sectional study to determine the quality of life and health care utilization among adults with Type 2 Diabetes Mellitus in an urban resettlement colony of Delhi. The study will be carried out by conducting house-to-house visits. Participants will be interviewed using a pre designed pre tested questionnaire. |