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CTRI Number  CTRI/2022/07/043944 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 06/06/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The overall aim of the Meaningful Mobility project is to employ an integrative approach to explain mobility practices in later life in relation to well-being.  
Scientific Title of Study   Meaningful Mobility 
Trial Acronym  MM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Sussana Patil 
Designation  Research Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Room no 33, Transdisciplinary Centre for Qualitative Methods, Department of Health Information, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9742503178  
Fax    
Email  suzane109@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya Sussana Patil 
Designation  Research Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Room no 33, Transdisciplinary Centre for Qualitative Methods, Department of Health Information, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9742503178  
Fax    
Email  suzane109@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varalakshmi Chandra Sekaran 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Community Medicine, Melaka Manipal Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535810325  
Fax    
Email  varalakshmi.cs@manipal.edu  
 
Source of Monetary or Material Support  
Meaningful Mobility project is funded by the European Research Council (ERC). Manipal Academy of Higher Education will receive funds from the University of Groningen, as a Third Party providing a service in the ERC-funded project 
 
Primary Sponsor  
Name  Dr Divya Sussana Patil 
Address  Room no 33, Transdisciplinary Centre for Qualitative Methods, Department of Health Information, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Sussana Patil  Manipal  Transdisciplinary Centre for Qualitative Methods, Department of Health Information, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 		 9742503178

suzane109@gmail.com 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Older adults with no impairments beyond the common impairments that come with age, stroke survivors and early stage dementia who are able to provide informed consent 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Older adults aged 55 and older, with common impairments that come with age; OR
Older stroke survivors aged 55 and older; OR
Older adults experiencing memory issues such as Mild Cognitive Impairment or early stage Alzheimer’s; OR
Primary informal caregivers of older adults with stroke or memory issues. 
 
ExclusionCriteria 
Details  Younger than 55 years;
Older adults with impairments beyond common impairments that come with age;
Older adults with Alzheimer’s or another form of dementia in the later stages;
Older adults who are not able to give informed consent for participating in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Since this is a qualitative study, it is not relevant to discuss in terms of associations between variables. The study will generate insight into specific themes such as mobility, capability and functioning of older adults, and well-being  Twice during the study period (once during the rainy season and once during the dry season) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/09/2022 
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   Researchers from India will contribute in the dissemination of project outcomes through journal publications in gerontological and public health journals, such as Social Science and Medicine, and the Gerontologist.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Mobility or physical movement contributes to health and well-being in later life and is a key issue in gerontological research. Most studies have focused on the contribution of outdoor mobility to active ageing, but physical and cognitive impairments restrict the mobility of many older adults. Meaningful Mobility will take a more comprehensive approach than previous research. It will be the first to connect the capability approach to mobility research to study diversity in movement within and between places by healthy and impaired older adults. The Meaningful Mobility project emphasizes the diversity in mobility of older adults by investigating three research gaps: (1) mobility of impaired older adults, (2) indoor mobility in later life and (3) mobility of older adults in different socio-cultural settings. 
In accordance with the mixed-methods design, participant recruitment will be driven by a stratified purposive sampling rationale that is common in mixed-methods research (Teddlie & Yu, 2007). The project aims to generate comprehensive insights at the individual level, and not to achieve statistical representation. The sample size is small enough to enable an in-depth grounded visualization of the data generated by the different methods (Knigge & Cope, 2006). Grounded visualization was developed to integrate diverse forms of data to uncover the multiple meanings associated with a topic and to contribute to theory building.
 
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