| CTRI Number |
CTRI/2017/09/009839 [Registered on: 19/09/2017] Trial Registered Prospectively |
| Last Modified On: |
19/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Dietary awareness programme and its impact on patients undergoing Haemodialysis. |
|
Scientific Title of Study
|
-Effectiveness of Nurse-Led Dietary Counseling on Knowledge, Nutritional requirements and Non- compliance behavior of patients undergoing Haemodialysis |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sarita Telma Fernandes |
| Designation |
Associate Prof |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Dept of PPN
Nitte university , Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964380566 |
| Fax |
0824-2203163 |
| Email |
saritafens@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fatima DSilva |
| Designation |
Principal |
| Affiliation |
Nitte Usha Institute Of nursing sciences |
| Address |
Nitte Usha Institute Of Nursing Sciences ,
Nitte University, Paneer, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9945064006 |
| Fax |
0824-2203163 |
| Email |
ftds_1970@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Shenoy M |
| Designation |
HOD, |
| Affiliation |
KSHEMA |
| Address |
Dept of Nephrology , KSHEMA
Nitte University
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844546066 |
| Fax |
0824-4257982 |
| Email |
mpradeepshenoynephro@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sarita Telma Fernandes |
| Address |
Nitte Usha Institute Of Nursing Sciences , Paneer Deralakatte |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nitte University |
Deralakatte , Mangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sarita Telma Fernandes |
K.S.Hegde Hospital |
NItte university,Deralkatte Mangalore
Dakshina Kannada
KARNATAKA |
9964380566
08242203163
saritafens@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nitte University Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ESRD undergoing dialysis center , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse Led counselling on nutrition requirement |
In this study nurse led counselling refers to an individualised Counselling programme on diet provided to haemodialysis patients which comprises of nutritional guidelines, menu, fluid intake, and measures for restriction of foods.
The counselling will be provided through using innovative teaching methods such as video, nutritional messages, printed materials. This structured programme will be administered by the investigator for duration of 10-20 mts every day for a week
|
| Intervention |
Nurse Led counselling on nutrition requirement |
In this study nurse led counselling refers to an individualised Counselling programme on diet provided to haemodialysis patients which comprises of nutritional guidelines, menu, fluid intake, and measures for restriction of foods.
The counselling will be provided through using innovative teaching methods such as video, nutritional messages, printed materials. This structured programme will be administered by the investigator for duration of 10-20 mts every day for a week
|
| Comparator Agent |
SaritaTelma Fernandes |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1. Are undergoing dialysis in K. S. Hegde Charitable Hospital, Deralakatte, Mangalore. Peripheral Health Centres at Karkala and Puttur
2.Could understand and speak Kannada
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA FOR SAMPLING
1. Patients with multiple organ failure
2.Patients who are critical ill
3. Unconscious patients
4. Patients not intersted in the counselling programme
5. Patients with HIV or Hepatitis.
-
6.Patients preparing for kidney transplantation.
-
7.Patients with ARF.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be a significant difference between knowledge of nutrition requirements among haemodialysis patients before and after dietary counselling programme.
H2: There will be a significant difference in the Biochemical parameters among haemodialysis patients before and after dietary counselling programme
|
2yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
H3: There will be a significant difference between nutritional status among haemodialysis patient before and after dietary counselling programme
H4: There will be a significant association between knowledge, nutritional status and selected demographic variables
|
2yrs |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
18/10/2017 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nurse Led Counselling may improve the knowledge of nutrition requirements and nutrition status among patients undergoing haemodialysis. Dietary counselling programme will bring about a changes in the biochemical parameters of patients with haemodialysis |