| CTRI Number |
CTRI/2019/08/020724 [Registered on: 14/08/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out the effect of Family focused training and counselling on foot care among people with diabetes in urban area |
|
Scientific Title of Study
|
Family centered training and counselling for enhancing foot self care practices towards prevention of Diabetic foot-A randomized controlled trial in urban Jodhpur. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRREHANA V R |
| Designation |
JUNIOR RESIDENT-ACADEMIC |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Department of community medicine and family medicine ,AIIMS Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9495349510 |
| Fax |
|
| Email |
dr.rehanavr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRASANNA T |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Department of community medicine and family medicine ,AIIMS Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9843172412 |
| Fax |
|
| Email |
drprasanmail@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRREHANA V R |
| Designation |
JUNIOR RESIDENT-ACADEMIC |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Department of community medicine and family medicine ,AIIMS Jodhpur.
RAJASTHAN
342005
India |
| Phone |
9495349510 |
| Fax |
|
| Email |
dr.rehanavr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR REHANA V R |
| Address |
JUNIOR RESIDENT ACADEMIC
DEPARTMENT OF COMMUNITY MEDICINE AND FAMILY MEDICINE
AIIMS JODHPUR |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prasanna T |
DEPARTMENT OF COMMUNITY MEDICINE AND FAMILY MEDICINE
AIIMS JODHPUR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rehana V R |
Shree Swami Prabuthanand Hospital |
UHTC Pratap nagar
Jodhpur
Jodhpur
RAJASTHAN |
9495349510
dr.rehanavr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family centered training and counselling |
Intervention given to people with diabetes and their family members which includes face to face talk,pamphlet,short video,power point presentation and demonstration.It will cover concepts of what is diabetes, its complications including diabetic foot,causes,risks,methods of prevention and treatment with special emphasize on foot care. |
| Comparator Agent |
standard care practice |
usual treatment protocol for diabetes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
people with diabetes on treatment, attending NCD OPD Urban health centre ,Pratap nagar |
|
| ExclusionCriteria |
| Details |
those with history of amputation
those with active foot problems like ulceration ,spreading infections, critical limb ischaemia or gangrene. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowledge indicators regarding foot self care in people with diabetes and their family members
Foot self care practice indicators in people with diabetes
|
at baseline and 6month post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Indicators of selfcare practices for diabetes
Characteristics involvement of family members in foot self care
Diabetes treatment care and behavioural parameters |
at baseline and 6month post intervention |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2019 |
| Date of Study Completion (India) |
01/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized,open labelled study to assess the effectiveness of family centered training and counselling in enhancing the foot self care practice in people with diabetes availing services at non-communicable disease OPD of Urban health training center , Pratap nagar, Jodhpur. This was taken as Post Graduate dissertation for the partial fulfillment of MD degree.Participant will be people with diabetes more than 18 years ,those without any history of amputation or active foot problem like foot ulceration,spreading infection,or gangrene.Participants meeting the selection criteria and willing to participate in study will be enlisted from UHTC Pratap nagar and will be randomly assigned to 2 groups with sealed envelops after getting informed consent.For baseline assessment all study participants and family members will be interviewed using a pre-designed semi-structured questionnaire which will include socio-demographic information,questions related to foot self care, diabetic self care etc to assess knowledge and practices. Relevant clinical and treatment parameters would be obtained from clinical records of the patients.Knowledge and involvement of in foot self care by family members would be obtained by questionnaire.For one group family centered training and counselling will be given ,other group will receive standard of care(routine OPD care).After 6 months post intervention, an endline assessment will be done to assess the improvement with same questionnaire and methods. Comparison will be done between end line data of both groups. |