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CTRI Number  CTRI/2025/02/079835 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Strategy combining self-management, community health workers, and stakeholder capacity building ]  
Study Design  Other 
Public Title of Study   Testing a new strategy to help adults with arthritis stay physically active 
Scientific Title of Study   Evaluating a multicomponent strategy to promote physical activity among adults with inflammatory arthritis and osteoarthritis attending urban primary health centers in Bhubaneswar India  
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 Ansuman Panigrahi 
Designation  Scientist - E 
Affiliation  ICMR-Regional Medical Research Centre 
Address  ICMR-Regional Medical Research Centre, Bhubaneswar, Khordha, Odisha.

Khordha
ORISSA
751023
India 
Phone  9861412403  
Fax    
Email  dr.ansuman3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ansuman Panigrahi 
Designation  Scientist - E 
Affiliation  ICMR-Regional Medical Research Centre 
Address  ICMR-Regional Medical Research Centre, Bhubaneswar, Khordha, Odisha.

Khordha
ORISSA
751023
India 
Phone  9861412403  
Fax    
Email  dr.ansuman3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ansuman Panigrahi 
Designation  Scientist - E 
Affiliation  ICMR-Regional Medical Research Centre 
Address  ICMR-Regional Medical Research Centre, Bhubaneswar, Khordha, Odisha.

Khordha
ORISSA
751023
India 
Phone  9861412403  
Fax    
Email  dr.ansuman3@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India  
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR)  
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India  
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 Ansuman Panigrahi  ICMR-Regional Medical Research Center, Bhubaneswar  Division of Epidemiology, Chandrasekharpur, Bhubaneswar, Khordha, Odisha
Khordha
ORISSA 
9861412403

dr.ansuman3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICMR-Institutional Human Ethics Committee (IHEC), Regional Medical Research Centre, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M199||Osteoarthritis, unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi-component strategy   The strategy includes the following 3 evidence based interventions as its components: 1. Self management interventions 2. Community health worker engagement 3. Capacity building of stakeholders. The duration of such intervention is 6 months. 
Comparator Agent  Outcomes before intervention (Multicomponent strategy)  The study employs a quasi-experimental design which allows for the evaluation of cause-and-effect relationships by comparing outcomes before and after the intervention. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged 40-65 years diagnosed with inflammatory arthritis (IA) or osteoarthritis (OA) attending identified urban primary health centers in Bhubaneswar.

Individuals willing to participate in the multicomponent strategy intervention and follow-up assessments.  
 
ExclusionCriteria 
Details  Severe cognitive impairment or communication barriers hindering participation.

Presence of other significant comorbidities that may limit engagement in physical activity.

Individuals currently engaged in other structured physical activity programs.

Pregnant women or women planning to be pregnant in next 2 years.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in physical activity levels among adults with inflammatory arthritis and osteoarthritis attending UPHCs in Bhubaneswar  After intervention period of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in patient health outcomes (blood pressure, random blood sugar, lipid profile etc.); Extent to which the intervention reached the target population; Improvements in self-management skills; Extent to which health care providers and community health workers adopted and integrated the intervention into routine practice; Fidelity and quality of the intervention delivery; Enablers and barriers influencing the effective implementation of this strategy   After intervention period of 6 months 
 
Target Sample Size   Total Sample Size="380"
Sample Size from India="380" 
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)   20/02/2025 
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="2"
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  

The study evaluates the impact of a multicomponent strategy in promoting physical activity among adults with inflammatory arthritis (IA) and osteoarthritis (OA) attending urban primary health centres (UPHCs) in Bhubaneswar, India. It addresses multifaceted barriers hindering physical activity engagement among adults with IA and OA. The proposed multicomponent strategy integrates evidence-based components: self-management interventions, community health worker engagement, and capacity building of stakeholders, aiming to create a comprehensive approach to tackle these barriers. The study will be conducted in two selected UPHCs of Bhubaneswar. A quasi-experimental design will be employed which allows for the evaluation of cause-and-effect relationships by comparing outcomes before and after the intervention. Participants will include adults aged 40-65 years diagnosed with IA/OA and those individuals willing to participate in the multicomponent strategy intervention and follow up assessments. A qualitative research design will be carried out employing in-depth interviews with 10 individuals who have undergone the intervention, 5 community health workers, and 5 health care providers; 3 focus group discussion with community stakeholders. interventions Expected outcomes will be evidence of increased physical activity level, insights into self-management effectiveness, community health workers contributions and stakeholder perspectives. Additionally, enablers and barriers influencing the effective implementation of this strategy in the unique context of UPHCs will be identified.

 
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