| CTRI Number |
CTRI/2023/07/055569 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Occupational Therapy Diabetes Self-Management Program Trial |
|
Scientific Title of Study
|
Effectiveness of an occupation-centered self-management intervention on Occupational Performance and Quality of Life among Community-Dwelling Older Adults With Type 2 Diabetes Mellitus: A cluster randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHASHANK MEHROTRA |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Maniapl College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
08202923254 |
| Fax |
|
| Email |
shashank.mehrotra@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
SHASHANK MEHROTRA |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Maniapl College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
08202923254 |
| Fax |
|
| Email |
shashank.mehrotra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjitha S Shetty |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Community Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9110401395 |
| Fax |
|
| Email |
ranjitha.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Shashank Mehrotra
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal- Karnataka
INDIA- 576104 |
|
|
Primary Sponsor
|
| Name |
SHASHANK MEHROTRA |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Karnataka |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranjitha Shetty |
Rural Maternity and Child Welfare Home, (RMCWH), Kadekar |
Department of Community Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
09110401395
ranjitha.shetty@manipal.edu |
| Dr Ranjitha Shetty |
Rural Maternity and Child Welfare Home, (RMCWH), Udayavar |
Department of Community Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
09110401395
ranjitha.shetty@manipal.edu |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Occupation- centered diabetes self- management program |
These intervention sessions will be provided for 12 weeks and will focus on participation in daily activities and engagement in occupation, getting support from family members, goal setting, and improving self-management practices. The sessions will be based on the following themes-
• Introduction and awareness toward self-management
• Maintaining physical health
• Maintaining mental health and wellbeing
• Maintaining participation in various
• Fatigue management and energy activities and life roles conservation
• Maintaining social and leisure participation
• Medication management
• Effective communication
• Maintaining physical and strategies biochemical parameters
• Maintaining healthy nutrition and lifestyle |
| Comparator Agent |
Occupational Therapy |
12 weeks - Routine occupational therapy intervention based on the requirements of the occupational therapist. This may include mobility and balance training, ADL retraining, pain management, and sensory re-education. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Community-dwelling older adults aged 60 years and above.
ii) Having a diagnosis of type 2 DM for at least five years.
iii) Permanent residents of the field practice area of one of the health centers chosen for the trial
iv) Able to read and write (Kannada or English). |
|
| ExclusionCriteria |
| Details |
i) Any older adult with age-related cognitive decline or disabling conditions such as cerebrovascular accident, Parkinson’s disease, Alzheimer’s disease, and other known cognitive and psychiatric disorders.
ii) Any older adult with another chronic disease such as cancer, COPD, cardiac disease. iii) Any older adult who has undergone any surgery in the last year. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of activity participation |
Baseline
Three months
Six Months
Twelve months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life
Diabetes Self-management
Healthcare utilization
Biochemical parameter- glycated hemoglobin |
Baseline
Three months
Six Months
Twelve months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/08/2023 |
| 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
|
This study will comprise implementing an occupation-centered diabetes self-management intervention for community-dwelling older adults aged 60 years and above who have been diagnosed with Type 2 Diabetes in the last 5 years. Overall, the intervention will be structured for 12 weeks consisting of the following sessions delivered by an occupational therapist for two hours a week with two reinforcement sessions. These intervention sessions will focus on participation in daily activities and engagement in occupation, getting support from family members, goal setting, and improving self-management practices. The sessions will be based on the following themes- • Introduction and awareness toward self-management • Maintaining physical health • Maintaining mental health and wellbeing • Maintaining participation in various • Fatigue management and energy activities and life roles conservation • Maintaining social and leisure participation • Medication management • Effective communication • Maintaining physical and strategies biochemical parameters • Maintaining healthy nutrition and lifestyle
|