| 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
|
|
|
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
|
|
|
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. |