| CTRI Number |
CTRI/2017/11/010487 [Registered on: 14/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/11/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of skill training programme |
|
Scientific Title of Study
|
Effectiveness of skill training programme for the caregivers of the bedridden patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheethal Rozita |
| Designation |
Student |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING |
| Address |
Eve Villa , Church Compound , Bockapatna, Mangalore
Dakshina Kannada
Father Muller College of Nursing, Kankanady, Mangalore
Father Muller College of Nursing , A Unit of Father Muller Charitable Institution , Kankanady , Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9538727881 |
| Fax |
08242438906 |
| Email |
sheethalrozita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Victoria DAlmeida |
| Designation |
Professor |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING |
| Address |
Father Muller College of Nursing, Kankanady, Mangalore
Father Muller College of Nursing , A Unit of Father Muller Charitable Institution , Kankanady , Mangalore
Father Muller College of Nursing, Kankanady, Mangalore
Father Muller College of Nursing , A Unit of Father Muller Charitable Institution , Kankanady , Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880305653 |
| Fax |
08242438906 |
| Email |
victoriacornelio@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Victoria DAlmeida |
| Designation |
Professor |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING |
| Address |
Father Muller College of Nursing, Kankanady, Mangalore
Father Muller College of Nursing , A Unit of Father Muller Charitable Institution , Kankanady , Mangalore
Father Muller College of Nursing, Kankanady, Mangalore
Father Muller College of Nursing , A Unit of Father Muller Charitable Institution , Kankanady , Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880305653 |
| Fax |
08242438906 |
| Email |
victoriacornelio@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital, Kankanady, Mangalore |
|
|
Primary Sponsor
|
| Name |
Sheethal Rozita |
| Address |
Father Muller College of Nursing, Kankanady, Mangalore |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Mrs Victoria DAlmeida |
Father Muller Medical College Hospital |
No S & T ward
Dept of Medicine
Father Muller Medical college hospital
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA |
9880305653
08242438906
victoriacornelio@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CAREGIVERS OF THE BEDRIDDEN PATIENTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
health teaching |
teaching the techniques of changing the position, back care and personal hygiene |
| Comparator Agent |
Pre test- assessing the primary skill prior to the skill training programme |
Post test - assessing the skill after administering the skill training programme |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Care givers those who are close relatives
Care givers those who can read and understand kannada |
|
| ExclusionCriteria |
| Details |
•Caregivers of the critically ill patients
•Caregivers of the bedridden patients who are not willing to participate in the study.
•Caregivers of the bedridden patients who are above the age of 60 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The skill training program The training program
facilitated them to gain more skill about the selected care activities
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve total care of bedridden patient and prevent complications related confinement in the bed |
30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/11/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Under process of publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An evaluatory approach with one group pre test post test design was used for the present study. The sample consisted of 50 caregivers of the bedridden patients selected by using purposive sampling method. Data was collected by administering observation checklist and an opinionnaire. Data was analysed using descriptive statistics and inferential statistics.
The findings of the study showed that the mean pre test skill score was 19 and the mean post test skill was 47 hence the skill training programme was effective for the caregivers .
There was no statistical significant association between the pre test skill score and selected demographic variable. The caregivers had a very good opinion about the skill training programme.
|