| CTRI Number |
CTRI/2022/07/043856 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
07/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Other (Specify) [management of dermatophytosis and scabies patient ] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to assess the effectiveness of ‘nurse led interventions’ for management of Dermatophytosis and scabies on selected outcomes variables |
|
Scientific Title of Study
|
A clustered Randomized Control Trial on the effectiveness of ‘nurse led interventions’ for management of Dermatophytosis and scabies on selected outcomes variables among population residing, in Dhanas, and Dadu Majra Colony UT. Chandigarh (2021-2023). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sankita Sandal |
| Designation |
Msc Nursing Student |
| Affiliation |
NINE PGIMER CHANDIGARH |
| Address |
ROOM NO. 305 NINE PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018218508 |
| Fax |
|
| Email |
sankitasandal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita |
| Designation |
Lecturer NINE PGIMER |
| Affiliation |
NINE PGIMER CHANDIGARH |
| Address |
Room no. 305 NINE PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita |
| Designation |
Lecturer NINE PGIMER |
| Affiliation |
NINE PGIMER CHANDIGARH |
| Address |
Room no. 305 NINE PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER (Post graduate institute of medical education research) |
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NATIONAL INSTITUTE OF NURSING EDUCATION |
NINE PGIMER, CHANDIGARH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sankita |
DHANAS AND DMC ( DADU MAJRA COLONY) UT Chandigarh |
Dhanas and DMC ( Dadu Majra Colony) UT PGIMER,CHANDIGARH
Chandigarh
CHANDIGARH |
7018218508
sankitasandal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group will be given Routine treatment as prescribed by doctor |
control group will be given Routine treatment as prescribed by doctor and will be asessed fir quality of life and treatment adherence |
| Intervention |
Nurse led intervention on management of Dermatophytosis and Scabies patients residing in DMC and DHANAS |
These interventions will be taught to patients like how they can will manage the superficial fungal infection at home for duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Dermatophytosis and scabies
Able to understand Punjabi, Hindi or English |
|
| ExclusionCriteria |
| Details |
Patients with severe secondary bacterial infections. Chronic illnesses like cardiovascular illness, severe hepatic, renal or CNS related diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A study to assess the effectiveness of ‘nurse led interventions’ for management of Dermatophytosis and scabies on selected outcomes variables among population residing, in Dhanas, and Dadu Majra Colony UT. Chandigarh (2021-2023). |
Primary outcome outcome will be assessed medication adherence , quality of life, management of superficial infection i.e at baseline and 10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop and implement protocol of a nurse led intervention on the management of dermatophytosis and scabies patient population residing, in Dhanas, and Dadu Majra Colony UT. Chandigarh |
secondary outcome will be assessed management of superficial fungal infection, medication adherence i.e at baseline and 10 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION AND NEED -Dermatophytosis and scabies among the most common ones due to the growing prevalence have become a worldwide public health issue. Due to poor hygienic condition of population, hot and humid climate, low socioeconomic status, crowded living environment, and poor medical care and wearing of dirty clothing with odour are the major risk factors for Dermatophytosis and Scabies. However, in India, the role of the nurses in the management of dermatologic conditions is limited. We couldn’t find any research on nurse-led interventions for Dermatophytosis and scabies. We will provide nurse-led interventions, counselling, and health education to superficial fungal patients as part of this study to determine the efficacy of these interventions. Based on the significant improvement in treatment related outcomes in this study, nurse-led interventions can be recommended to improve the patient’s quality of life, psychosocial issues, and help the patient adhere to his treatment. So by developing nurse led interventional package on management of superficial fungal infections (Dermatophytosis and Scabies) in home set up by nurse to educate them that lifestyle modification, right treatment, management improvement in personal hygiene helps them in developing habits of doing structured modification in treatment adherence. So keeping the above factors in mind the need was felt to conduct a study to assess the effectiveness of nurse led interventional package on management of Dermatophytosis and scabies that will encourage the patients for self- management and also to take every effort that contribute the patients to increase awareness and life style modifications and hence improving the treatment outcomes and decrease the recurrences. The developed booklet will also work as a ready references for the patients and will be helpful in future for patient suffered with superficial fungal infections.Objectives: Ø To identify the patients having Dermatophytosis and Scabies residing in selected communities. Ø To develop and implement the nurse led intervention for management of patients suffering from Dermatophytosis and scabies residing in selected communities. Ø To assess the effectiveness of Nurse Led Intervention on treatment adherence, quality of life, and management of Dermatophytosis and Scabies residing in selected communities. Nurse Led Intervention Protocol: It includes the Nurse-led intervention program details which will be conducted during the study in interventional phase. It will contain all the information regarding Dermatophytosis and scabies which will be given to patient and planning of how these procedures will be conducted. Protocol will be prepared in the form of booklet ‘Know about skin fungal infection’ and flash book · Personal Hygiene · Dressing · Diet · Personal Hobbies · Lifestyle changes, enhanced self- care, improve compliance · Proper use of medications · Counselling about treatment · Non pharmacological measures · Physical Exercises Re-occurrence Prevention technique |