| CTRI Number |
CTRI/2024/08/071775 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Community Based Intervention To Improve The Quality Of Life Of Patient With Diabetes and Hypertension |
|
Scientific Title of Study
|
Behavioral Management Of Diabetes And Hypertension Among Urban Poor Patients: A Community-Based Intervention Study In Adopted Slums Of IMS & SUM Hospital,Bhubaneswar, Odisha.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Kumari Samantaray |
| Designation |
Associate Professor |
| Affiliation |
SUM Nursing College, faculty of Nursing,Siksha O Anusandhan Deemed to be University |
| Address |
Room no-04, Second floor, SUM Nursing College, Campus-2, Siksha O Anusandhan Deemed to be University, K-8, Kalinga Nagar, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
7381359676 |
| Fax |
|
| Email |
krishnasamantray@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Kumari Samantaray |
| Designation |
Associate Professor |
| Affiliation |
SUM Nursing College, faculty of Nursing,Siksha O Anusandhan Deemed to be University |
| Address |
Room no-04, Second floor, SUM Nursing College, Campus-2, Siksha O Anusandhan Deemed to be University, K-8, Kalinga Nagar, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
7381359676 |
| Fax |
|
| Email |
krishnasamantray@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasmita Das |
| Designation |
Associate Dean |
| Affiliation |
SUM Nursing College, faculty of Nursing,Siksha O Anusandhan Deemed to be University |
| Address |
Room no-02, Ground floor, SUM Nursing College, Campus-2, Siksha O Anusandhan Deemed to be University, K-8, Kalinga Nagar, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
9776645936 |
| Fax |
|
| Email |
das.sasmita2@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUM Nursing College, Siksha O Anusandhan Deemed To Be University, Bhubaneswar. |
|
|
Primary Sponsor
|
| Name |
Krishna Kumari Samantaray |
| Address |
Room no-02, Second Floor, SUM Nursing College, Campus-2, siksha O Anusandhan University, K-8, Kalinga Nagar, Bhubaneswar,751003. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Krishna Kumari Samantaray |
Tapoban slum |
Lane-1,Tapoban High School road,Near B K Art College, Khandagiri, Bhubaneswar, 751030.
Khordha
ORISSA |
7381359676
krishnasamantray@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute Of Medical Sciences (IMS) and SUM Hospital, Siksha O Anusandhan Deemed To Be University, Bhubaneswar. |
Approved |
| NOC From The Local Authority |
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 |
Community-Based Intervention (CBI) |
In This study, Community-Based Intervention Is A Non-Pharmacological Program Which Includes Demonstration And Practice Sessions Of Yoga Or Yogasanas. Here, The Yoga Sessions Will Be Practiced For Six Days/Week (Monday-Saturday) From Morning 7AM-7:45AM (45mins) For a Period Of 6 Weeks. The yoga Session Will be Carried Out In Group. There Will be 15-20 Participants in Each Group. The Researcher Will Take The Help Of A Yoga Professional To Carry Out The Yoga Session. The Yogasana Includes In This Yoga Practice Sessions Are Sukhasana, Vajrasana, Trikonasana, Paschimottanasana, Pavana mukhtasana, Bhujangasana, Shavasana, Kapalabathi and Meditation.After 6 Weeks Of Intervention Period The Researcher Will Pay A Visit To The Participants Once In Every Weeks Upto The 6 Month Intervention Period. To Get The Information Regarding Practice Of Yogasanas. The Researcher Will Do The Post Intervention Test On 2nd, 4th And 6th Month Of The Total Intervention Period. To Know The Post Intervention Results The Researcher Will Use MMAS-8 Tool To Know The Adherence To The Medication,EQ-5D Tool to Measure The Quality Of Life Of The participants. To Measure The Health Related Outcome, The Researcher will Measure The Blood Pressure (BP) By using Sphygmomanometer & Stethoscope and Do The Random Blood Sugar (RBS) Test Using Needle, Glucometer & Glucometer Strip. This Program Was Developed After Consultation With The Yoga Professionals and Guidance From The Concerned Physicians. |
| Comparator Agent |
Standard treatment |
Patient with Diabetes and Hypertension will get standard treatment. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patients who are diagnosed with both Diabetes and Hypertension more than one year.
Patients who are willing to participate in the study and available at the time of data collection.
|
|
| ExclusionCriteria |
| Details |
Who are diagnosed with any mental illness.
Who are having physical limitations to perform Yoga.
Patient who had undergone any surgery .
Patient who cannot understand Odia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behavioral Outcome Includes Of Adherence To Medication, Quality Of Outcome, Health Related To Outcome i.e. Blood Pressure (BP), Blood Sugar. |
The Researcher Will Do The Post Intervention Test On 2nd, 4th And 6th Month Of The Total Intervention Period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Health Outcome
Quality of life
Medication adherence |
6 month |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
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 2 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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 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
|
As because the cases of Diabetes and Hypertension is rising globally as well in India. The quality of life of the patient is compromising due to its consequences. Hence the authors has come up with this trial to introduce the Community-Based Intervention with continuous follow up of patients up-to 6 months as well to see its effect on the behavioral outcome.
Hypothesis: H01-There is no significant difference between post test score of experimental and control group in terms behavioral outcome. H02- There is no significant change in patients blood pressure, blood sugar and quality of life before, during and after receiving intervention. |