| CTRI Number |
CTRI/2024/09/073487 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral
Nutraceutical |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Frailty management in multimorbidity patient |
|
Scientific Title of Study
|
Effectiveness and Implementation of a Primary
Healthcare Intervention for Screening and Management of Multimorbidity and Frailty among
Urban Older Adults of Bhubaneswar: The Multi-FrAME Study |
| Trial Acronym |
Multi-FrAME |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JAYA SINGH KSHATRI |
| Designation |
Scientist C |
| Affiliation |
ICMR Regional Medical Research Centre |
| Address |
ICMR Regional Medical Research Centre, Chandrasekharpur
Bhubaneswar, Odisha
Khordha
ORISSA
751023
India |
| Phone |
9937572685 |
| Fax |
|
| Email |
kshatri.js@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JAYA SINGH KSHATRI |
| Designation |
Scientist C |
| Affiliation |
ICMR Regional Medical Research Centre |
| Address |
ICMR Regional Medical Research Centre, Chandrasekharpur
Bhubaneswar, Odisha
ORISSA
751023
India |
| Phone |
9937572685 |
| Fax |
|
| Email |
kshatri.js@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr JAYA SINGH KSHATRI |
| Designation |
Scientist C |
| Affiliation |
ICMR Regional Medical Research Centre |
| Address |
ICMR Regional Medical Research Centre, Chandrasekharpur
Bhubaneswar, Odisha
ORISSA
751023
India |
| Phone |
9937572685 |
| Fax |
|
| Email |
kshatri.js@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| ICMR Regional Medical Research Centre
Chandrasekharpur
Bhubaneswar 751023
Odisha
India |
|
|
Primary Sponsor
|
| Name |
ICMR Regional Medical Research Centre |
| Address |
Chandrasekharpur
Bhubaneswar 751023
Odisha
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 Jaya Singh Kshatri |
Department of Clinical Research, Room No. 40, ICMR Regional Medical Research Centre |
Chandrasekharpur
Bhubaneswar 751023, Odisha
India
Khordha
ORISSA |
9937572685
kshatri.js@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR RMRC, Bhubaneswar, Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi-FrAME intervention package |
Multi-FrAME intervention package will be developed including regular health assessments, personalized
care plans, medication management, physical activity promotion, social support, and
self-management strategies. The trail duration is 18 months. Intervention is to be administered once every month via home and facility visit. Outcomes will be assessed as 6 and 12 months. |
| Comparator Agent |
Standard of care |
Routine care provided at public health facilities under National Health Programme. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants should be residing within the urban area of Bhubaneswar city with multimorbidity
2. Participants are willing to participate in the study by providing informed written consent and agree to be followed up for two years. |
|
| ExclusionCriteria |
| Details |
Participants with
1. Severe cognitive impairment
2. Seriously ill/bed-ridden patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health-related quality of life (HRQoL) |
6 & 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frailty progression, functional ability, healthcare
utilization, healthcare
expenditure, satisfaction, medical adherence and mortality. |
6 & 12 months |
|
|
Target Sample Size
|
Total Sample Size="430"
Sample Size from India="430"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Rationale: Population ageing in low-and middle-income countries (LMICs) such as India has led to a rise in multimorbidity and frailty which have a bidirectional association affecting the quality of life. However, lack of specific intervention prohibits these individuals from getting additional support beyond disease oriented standard care. Novelty: There is a paucity of evidence on interventions for multimorbidity and frailty in low-and middle income settings which necessitates the development and testing of such an intervention and evaluating its implementation at primary healthcare levels. Objectives: To co-design and test the effectiveness of a primary healthcare intervention package for multimorbidity and frailty assessment & management among elderly (Multi-FrAME) on progression of frailty, functional ability, and patient-reported outcome measures (health-related quality of life, healthcare utilization, and life satisfaction). We will also evaluate the fidelity, acceptability, adoption, and sustainability of Multi-FrAME intervention. Methods: We propose the development and testing the effectiveness and implementation of a primary care based Multi-FrAME intervention package, by following three stages: a) Intervention Development, b) testing effectiveness of the intervention, c) implementation assessment. A Cluster Randomized Controlled Trial where we will randomly allocate the Health and Wellness Centers (HWCs) in Bhubaneswar city into intervention and control groups would be undertaken. Participants (≥60 years) residing within urban area of Bhubaneswar with multimorbidity and some degree of frailty will be included. Expected Outcome: This study will develop a primary care based intervention package, and generate evidence on its effectiveness and implementability which could further be deployed in other countries/similar settings. |