| CTRI Number |
CTRI/2025/08/093150 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Multimorbidity and their Influence on Disability among the Geriatric Population |
|
Scientific Title of Study
|
Prevalence and Patterns of Multimorbidity and their Influence on Disability among the Geriatric Population in a Rural Community: A Cross Sectional 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 |
DR Vaseem Naheed Baig |
| Designation |
Head of The Department |
| Affiliation |
RUHS COLLEGE OF MEDICAL SCIENCES |
| Address |
First floor , Academic Building, Department of Community Medicine , RUHS COLLEGE OF MEDICAL SCIENCES, Sector-11, Kumbha Marg, Pratap Nagar, Jaipur, First floor , Academic Building, Department of Community Medicine , RUHS COLLEGE OF MEDICAL SCIENCES, Sector-11, Kumbha Marg, Pratap Nagar, Jaipur, Jaipur RAJASTHAN 302033 India |
| Phone |
9828347157 |
| Fax |
|
| Email |
drvaseemnaheed@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Vinod Kumar SV |
| Designation |
Dean, SD Gupta School of Public Health, IIHMR, |
| Affiliation |
IIHMR UNIVERSITY |
| Address |
IIHMR University
Prabhu Dayal Marg ,Near Sanganer Airport, Jaipur - 302029 IIHMR University
Prabhu Dayal Marg ,Near Sanganer Airport, Jaipur - 302029 Jaipur RAJASTHAN 302029 India |
| Phone |
7427073209 |
| Fax |
|
| Email |
vinod@iihmr.edu.in |
|
Details of Contact Person Public Query
|
| Name |
DR VINOD KUMAR SV |
| Designation |
Dean, SD Gupta School of Public Health, IIHMR |
| Affiliation |
IIHMR UNIVERSITY |
| Address |
IIHMR University
Prabhu Dayal Marg ,Near Sanganer Airport, Jaipur - 302029 IIHMR University
Prabhu Dayal Marg ,Near Sanganer Airport, Jaipur - 302029 Jaipur RAJASTHAN 302029 India |
| Phone |
07427073209 |
| Fax |
|
| Email |
vinod@iihmr.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR Vaseem Naheed Baig |
| Address |
First floor,Community Medicine department ,RUHS college of medical sciences, Sector-11, Kumbha Marg, Pratap Nagar, Jaipur,
Rajasthan 302033, India |
| 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 |
| DR Vaseem Naheed Baig |
IIHMR |
School of Public health Jaipur RAJASTHAN |
9828347157
drvaseemnaheed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board , IIHMR university , jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Both gender with age more than 60 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Both gender with age more than 60 years
2.Residing within the designated rural community more than 10 years
|
|
| ExclusionCriteria |
| Details |
1. Do not give consent to participate in study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of multimorbidity and pattern of its combinations |
6 months after getting ethical approval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of multimorbidity on disability among the geriatric population. |
6 months after getting ethical approval. |
|
|
Target Sample Size
|
Total Sample Size="420" Sample Size from India="420"
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)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvaseemnaheed@gmail.com].
- For how long will this data be available start date provided 16-12-2025 and end date provided 16-12-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
INTRODUCTION Importance
of Multimorbidity: Multimorbidity is associated with
increased healthcare utilization, decreased quality of life, and higher
mortality rates among older adults. By comprehensively understanding the prevalence
and patterns of multimorbidity, healthcare providers can better tailor
interventions to manage multiple chronic conditions simultaneously, thereby
improving health outcomes and reducing healthcare costs.
Rural
Health Disparities: Rural communities often lack access to
specialized healthcare services, leading to delayed diagnosis and management of
chronic conditions. Investigating multimorbidity within this context is crucial
for developing context-specific interventions to address the unique healthcare
needs of rural geriatric populations.
Contribution
to Evidence-Based Practice: Findings from this study can
inform the development of evidence-based guidelines and interventions tailored
to rural geriatric populations, ultimately improving healthcare delivery and
outcomes in these underserved communities.
In
summary, this study will address a critical gap in the literature by
investigating prevalence and pattern of multimorbidity and their influence on
disability among the geriatric population in a rural community setting. This
research aims to generate valuable insights that can inform targeted
interventions to enhance the health and well-being of older adults living in
rural areas. AIM of Study The aim of this study
is to comprehensively investigate the prevalence and pattern of multimorbidity and
their influence on disability among the geriatric population residing in a
rural community. Objectives - To estimate the prevalence of multimorbidity among the
geriatric population in a rural community.
- To identify patterns of multimorbidity, including disease combinations.
- To assess the association of multimorbidity on disability
among the geriatric population.
- Study
Design: cross sectional observational study
design
study setting : Random sampling methods will be adopted for
selection in study population, in which 21 villages will be randomly selected
by using the random table method. Households will be selected within each
village by systemic random sampling. Sampling
duration: 6 months after getting ethical approval.
Study
Universe: Population age more than 60 years.
Study
Population: Rural population age more than 60 years residing
in Jaipur district.
Inclusion
criteria:
1.
Both gender with age more than 60 years .
2.
Residing within the designated rural community more than 10
years.
Exclusion
criteria:
1.
Do not give consent to participate in study. Sample Size = 420 , calculated on hypothesis testing methods
based on the following assumption: 95% confidence interval, assuming 42% of
prevalence for the morbidity for maximum sample size Study
Tool : The
Multimorbidity Assessment Questionnaire for Primary Care represents a
valuable tool for assessing and managing multimorbidity. |