| CTRI Number |
CTRI/2022/12/048477 [Registered on: 26/12/2022] Trial Registered Prospectively |
| Last Modified On: |
22/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF PATIENT EDUCATION ON KNOWLEDGE OF PHYSICAL ACTIVITY, ITS PRACTICES, AND SELF CARE BEHAVIOURS IN PATIENTS WITH DIABETES TYPE 2 |
|
Scientific Title of Study
|
IMPACT OF PATIENT EDUCATION ON PHYSICAL ACTIVITY, ITS PRACTICES, AND SELF CARE BEHAVIOURS IN TYPE 2 DIABETIC PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POOJA RANA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
GANESHA ENCLAVE,BUDH VIHAR HOUSE NO. 144 , BLOCK B, GALI NO. 6
Ghaziabad
UTTAR PRADESH
201001
India |
| Phone |
8920098230 |
| Fax |
|
| Email |
rana.pooja2400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
POOJA RANA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
GANESHA ENCLAVE,BUDH VIHAR HOUSE NO. 144 , BLOCK B, GALI NO. 6
UTTAR PRADESH
201001
India |
| Phone |
8920098230 |
| Fax |
|
| Email |
rana.pooja2400@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
POOJA RANA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
GANESHA ENCLAVE,BUDH VIHAR HOUSE NO. 144 , BLOCK B, GALI NO. 6
UTTAR PRADESH
201001
India |
| Phone |
8920098230 |
| Fax |
|
| Email |
rana.pooja2400@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
POOJA RANA |
| Address |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| 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 |
| DR PRERNA SAXENA PT |
PHYSIOTHERAPY DEPARTMENT |
2nd floor
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY
KARKARDOOMA, VIKAS MARG, NEW DELHI - 110092
East
DELHI |
9999456988
prernasaxena.88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AMAR JYOTI INSTITUTIONAL REVIEW BOARD-ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with T2DM for more than 1 yr.
2. Age: 40 yrs. & above
3. Ability to understand spoken English
4. Both genders
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Uncontrolled hypertension
3. Any medical & neurological condition restricting active participation in physical activity
4. Any recent h/o musculoskeletal injury & surgery in the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 PHYSICAL ACTIVITY KNOWLEDGE QUESTIONNAIRE
2 GPAQ QUESTIONNAIRE
3 SELF – CARE ACTIVITY QUESTIONNAIRE |
AT BASELINE AND AFTER ONE MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
02/01/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT DONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The subjects will be first asked to fill out preliminary
screening form prepared by researcher evaluating the demographic data and the
sampling criteria. Duly signed consent would be taken from each subject and
procedure of study would be explained to each individual before beginning the
data collection.
All the subjects will be asked to fill out the
questionnaires to assess their knowledge of physical activity, its practices,
and self- care behavior by using the physical activity knowledge questionnaire,
GPAQ, self-care behavior questionnaire respectively.
After receiving the initial data. Subjects
will be educated about general information about T2DM, physical activity, self–care behavior
monitoring, and diet and lifestyle modification by face-to-face consultation, through
lectures and distributing the education material (adopted from ICMR 2018, American
diabetic association guidelines). To ensure the understanding of lectures/
interaction with the diabetic patients;
researcher will take a quiz comprising of 10 questions immediately after the
end of session. The patients scoring less than 50 % will be educated again in
those domains.
After one month of receival of patient’s
education, subjects will be asked to fill out the physical activity knowledge
questionnaires, GPAQ, self-care behavior questionnaire. |