FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/016064 [Registered on: 17/10/2018] Trial Registered Prospectively
Last Modified On: 16/10/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Asking the experience of women regarding the effect of Urinary Tract Infection (UTI) on their daily activities and assessing the effectiveness for Structured Counseling and Preventive Strategies(SCAPS) on their awareness regarding UTI and expressed habitual practices in the prevention of UTI. 
Scientific Title of Study   Lived experience of clients with Urinary Tract Infection (UTI) on Quality of Life (QOL), awareness, expressed habitual practices and effectiveness of SCAPS (Structured counseling and preventive strategies) on UTI among the women of reproductive age group 
Trial Acronym  SCAPS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonia Karen Liz Sequera 
Designation  Assistant Professor 
Affiliation  Father Muller college of Nursing,Mangaluru 
Address  Father Muller College of Nursing,FMCI, Kankanady, Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  07353074151  
Fax  08242438906   
Email  soniakaren@fathermuller.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Leena KC 
Designation  Dean/Principal 
Affiliation  Yenepoya college of Nursing,Mangaluru 
Address  Yenepoya college of Nursing, Yenepoya University, University Road, Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448059698  
Fax    
Email  leenakchacko@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sonia Karen Liz Sequera 
Designation  Assistant Professor 
Affiliation  Father Muller college of Nursing,Mangaluru 
Address  Father Muller College of Nursing,FMCI, Kankanady, Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  07353074151  
Fax  08242438906   
Email  soniakaren@fathermuller.in  
 
Source of Monetary or Material Support  
Sonia Karen Liz Sequera,Father Muller College of Nursing,FMCI,Mangaluru-575002 
 
Primary Sponsor  
Name  Sonia Karen Liz Sequera 
Address  Father Muller College of Nursing,FMCI,Kankanady,Mangaluru 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sonia Karen Liz Sequera  Father Muller Medical College Hospital,Mangaluru  Obstetric and Gynecology outpatient department(OPD Number 19); Urology Outpatient department( OPD Number 44)
Dakshina Kannada
KARNATAKA 		 07353074151
08242438906
soniakaren@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine Treatment which includes antibiotic Course prescribed by the Doctor  The Women diagnosed with UTI postive for Uine Culture,presence of pus or leukocyte or nitrates and with moderate to severe typical symptoms will be recruited using Purposive sampling to assess their lived experience on Quality of life.Thereafter their awareness and expressed habitual practices in the prevention of UTI will be assessed(pretest).The women who are assigned in the control group will undergo only routine treatment which includes antibiotic course as prescribed by the urologist/physician.The post test of the awareness and expressed habitual practices will be again assessed in the 1st post test(after 3 months of pretest) & 2nd post test(after 6th month).After the completion of the study(after data collection) women in the control group will also be enrolled for intervention to prevent bias(ethical consideration). 
Intervention  SCAPS-Structured Counseling & Preventive Strategies  The Women diagnosed with UTI positive for Urine Culture, presence of pus or leukocyte or nitrates and with moderate to severe typical symptoms will be recruited using Purposive sampling to assess their lived experience on Quality of life. Thereafter their awareness and expressed habitual practices in the prevention of UTI will be assessed(pretest).The women who are assigned in the intervention group will undergo routine treatment prescribed by the Doctor and simultaneously undergo SCAPS intervention ( Structured Counseling & Preventive Strategies).SCAPS Include 2 sessions in the 1st month immediately after pretest and in the 3rd month after the pretest. In the 1st session women will undergo counseling, motivation therapy using snake and ladder game for healthy lifestyle, Educational video on prevention of UTI, Case scenarios with potential solutions & discussions. In the 2nd session women will have 2nd round of case scenarios with discussion and focused follow-up. Women will be encouraged to maintain log book daily(to check the voiding habits & healthy dietary habits),Informative messages in SMS/Watsapp at fortnightly basis. Telephonic follow-up will be done every month for 6 months. The 1st post test will be done in the 3rd month & 2nd post test in the 6th month. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  General Inclusion Criteria: Able to communicate & read in Kannada or English, gives written consent and accessible for the follow up throughout the study period,Women diagnosed with UTI positive for urine culture and urine microscopy and having moderate to severe typical symptoms based on UTI-Symptom Score Check list residing within Dakshina Kannada district(Mangaluru),
Able to access SMS (mobile) and /or Watsapp.
Qualitative strand inclusion criteria:Women experiencing typical moderate to severe symptoms of UTI and willing to share their experiences.

 
 
ExclusionCriteria 
Details  Hearing/Visual Impairment, Unconscious women
Diagnosed with major mental disorder, Congenital defects of Urinary system,Pregnant Women,Women with Menopause & hysterectomy,institutionalized women
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SCAPS will assist women with UTI to increase thier awareness and improve in expressed habitual practices   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improve self care abilities to prevent UTI.   Prevent UTI & Improve self care abilities at the 3rd month, 6th month after the intervention and throughout their life span 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Phase 1 
Date of First Enrollment (India)   01/01/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study intends to assess the  lived experience of women with Urinary Tract Infection on Quality of life and also finds the Effectiveness of Structured Counselling & Preventive Strategies (SCAPS)on the awareness and expressed habitual practices among the women of reproductive age group. 
Close