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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 08:38:39 GMT) CTRI Number CTRI/2018/12/016603 [Registered on: 11/12/2018] - Trial Registered Prospectively Last Modified On 07/12/2018 Post Graduate Thesis Yes Type of Trial Observational Type of Study Cross Sectional Study Study Design Other Public Title of Study A study to know what the community feels about the health services being provided through their local health clinic and to design a health clinic based on their current health needs. Scientific Title of Perception of the services provided through an urban health training centre among the residents in Study a coastal taluk of southern Karnataka and designing a model Wellness Centre - a Mixed Method Study. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Deepak Sudhakaran Trial Coordinator (multi-center study) Designation Post Graduate Affiliation Kasturba Medical College, Manipal Address Dept. of Community Medicine, KMC, MAHE, Manipal Udupi KARNATAKA 576104 India Phone 9995060163 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ranjitha S Shetty Query) Designation Associate Professor Affiliation Kasturba Medical College, Manipal Address Dept. of Community Medicine, KMC, MAHE, Manipal Udupi KARNATAKA 576104 India Phone 9110401395 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sneha D Mallya Designation Associate Professor Affiliation Kasturba Medical College, Manipal Address Dept. of Community Medicine, KMC, MAHE, Manipal Udupi KARNATAKA 576104 India Phone 9880893371 Fax page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Kasturba Medical College, MAHE, Manipal Primary Sponsor Primary Sponsor Details Name Kasturba Medical College Manipal Address Kasturba Medical College, Madhav Nagar, MAHE, Manipal Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Deepak Sudhakaran Kasturba Medical Department of 9995060163 College Community Medicine, KMC, MAHE, Manipal. dk.sudhakaran@gmail. Udupi com KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 18/09/2018 No Committee Kasturba Hospital Manipal Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Not screening for Health related issues. It is to understand the perception regarding the health services being provided at an Urban Health Training Centre. Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 90.00 Year(s) Gender Both Details Men and Women of age >18yrs residing in the field practice area of the Dept. of Community Medicine, KMC, Manipal at Malpe for > 5 years. Exclusion Criteria Exclusion Criteria Details Individuals who are unable to communicate due to physical or mental illness. Method of Generating Other Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints 1.Awareness of the participants with respect to September 2020 page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in the different health services being provided through the Urban Health Training Centre . 2. Satisfaction with respect to the various health services being provided at the same centre. 3. Assess the current health needs in the community. Secondary Outcome Outcome Timepoints 1. Socio demographic data like September 2020 age,gender,literacy,occupation,marital status, religion,type of family, socio economic status etc. 2. Known comorbidities of the participants and their family members. Target Sample Size Total Sample Size=474 Sample Size from India=474 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 01/01/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=2 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None yet Brief Summary This is a mixed method study done among the community who are dependent on the health services of an Urban Health Training Centre in a coastal taluk of southern Karnataka. The study will be done in 3 phases. Phase 1 Includes the cross-sectional part of the study which will be conducted in the field practice area at Malpe. House to house visit will be made. After explaining the objectives and purpose of the study a detailed information sheet will be provided to the study participant. If more than one eligible participants are there in the house, then, whoever volunteers to provide required information with regards to all the family members will be selected as the respondent. They will be interviewed after obtaining a written informed consent. This phase of personal interviews will continue till the desired sample size (474 families) is obtained. Phase 2 The utilizers and non-utilizers identified as per phase 1 of the study, will be recruited for FGDs which will take place at the UHTC,Malpe or any identified community hall based on the convenience of the participants.These groups will also include recognized community leaders from various backgrounds and social strata.They will be informed about the date, time and venue of the FGD to be held in their area.It will be led by a trained facilitator. Minimum of 8-10 participants will be invited for one FGD. After obtaining written informed consent the subjects will be briefed about the topic and discussion initiated with the help of an interview guide. The discussion will be recorded using a voice recorder.Besides the moderator who will lead the discussion, the FGD team will comprise of note-takers who will make hand-written verbatim notes and the observations made during the discussions in English and the local language. Other members of the team will be responsible for audio recording and constructing the sociogram. Each session would last for 60 – 90 minutes. A round of introduction will be carried out and the page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in participants will be encouraged to actively participate in the informal discussion. They will be told to freely express their views as there is no right or wrong answers and the information provided will be kept confidential. A FGD guide has been developed in english keeping in line with the objectives of the study and has been translated to the local language,Kannada. The facilitator will use this guide to lead the participants through a discussion to understand the views of the participants regarding the facilitators and barriers for the utilisation of the services provided by the existing centre, the kind of services which they would desire to avail of in a model wellness centre. This qualitative data will be to understand the perception of the community regarding the kind of services that should be provided in addition to what is already available at the centre and if any modifications need to be brought about in the way the current services are delivered. The discussion will be conducted in the local language and will be documented verbatim. Appropriate probes will be used to get relevant information from the participants. Phase 3 This phase will include taking inputs from the phases 1 & 2 and propose a design for a model Wellness Centre based on the perceived needs of the community. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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