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CTRI Number  CTRI/2024/05/066845 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Family adopted by medical graduates and followed up while providing necessary medical care to the family 
Scientific Title of Study   Implementation of family health risk assessment among the adopted families under medical colleges through interprofessional collaboration. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pavani Varma 
Designation  Associate Professor,Community Medicine 
Affiliation  Apollo Institute of Medical science and Research 
Address  Department of Community Medicine,Assistant Professors room
Department of Community Medicine,Assistant Professors room
Hyderabad
TELANGANA
500090
India 
Phone  9573712150  
Fax    
Email  pavanimims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pavani Varma 
Designation  Associate Professor,Community Medicine 
Affiliation  Apollo Institute of Medical science and Research 
Address  Department of Community Medicine,Assistant Professors room
Department of Community Medicine,Assistant Professors room
Hyderabad
TELANGANA
500090
India 
Phone  9573712150  
Fax    
Email  pavanimims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pavani Varma 
Designation  Associate Professor,Community Medicine 
Affiliation  Apollo Institute of Medical science and Research 
Address  Department of Community Medicine,Assistant Professors room
Department of Community Medicine,Assistant Professors room
Hyderabad
TELANGANA
500090
India 
Phone  9573712150  
Fax    
Email  pavanimims@gmail.com  
 
Source of Monetary or Material Support  
Apollo Institute of Medical Sciences and Research, Hyderabad. 
 
Primary Sponsor  
Name  Nil 
Address  NA 
Type of Sponsor  Other [No sponsorer available] 
 
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 
DrPavani Varma  Urban slum, Shaikpet ,Hyderabad  Apollo Institute of Medical Sciences and Research, Hydeerbad,Apollo Hospitals,Department of Community Medicine
Hyderabad
TELANGANA 		 9573712150

pavanimims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committe, Apollo Institute of Medical Sciences and researche  Approved 
Institutional Ethics Committe, Apollo Institute of Medical Sciences and researche  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Families given health education 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non randomized control trial.Awareness, behavioural and life style modification.1 year  The details of intervention are mentioned as below: 1. Each student will be allotted a family 2. After visit of the family by student, based on the health and disease profile of family the student will be prepared to create awareness among the family members. 3. The most common disease profiles seen in the family visits are diarrhea, pneumonia, anemia, diabetes, hypertension, underweight children, tuberculosis, leprosy and physiologic conditions such as antenatal and postnatal mothers. 4. The student will be guided through about the disease condition of the family. If a disease prevails not mentioned in the list the student will be guided by faculty of clinical department (for eg.General Medicine) to cater to needs of the patient. Health education that needs to be given to the family will be instructed beforehand so during next visit the student will create awareness in the family. 5. Not only disease profile but health promotion measures like safe and wholesome water consumption, safe disposal of solid waste, cleanliness of toilets, cleanliness of toilets and avoiding water collections in and around the house to prevent mosquito breeding. 6. If there are addictions in the family like smoking and alcoholism the students take opinion of psychologist to support the family members. In case a family member with addiction is willing to come out of it will be directed to a psychologist for counselling. 7. Nutritionist guidance will be given to students to educate the family about balanced diet. 8. Health care utilization –The family can choose from wide variety of services from both public and private sector. The family will be guided through the national programme available according to the need by the patient. Duration 2 years 
Comparator Agent  Non rndomized control trial-Intervention is not provided to the comparator group  The general health care services provided by the government through national programmes will be continued and analyzed at the end Duration 2 years 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All the families willing to participate in the study and gave consent. 
 
ExclusionCriteria 
Details  Non coopperative families are excluded 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To enhance the skills of the undergraduate students in performing health history risk assessment and impart education to minimize risk among the adopted families.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify diseases, ill health and malnutrition among the alloted families
2. Screening of patients with family history of diseases.
3. To assess the communication skills and empathy among students.
4. To determine family satisfaction level after student intervention.
 		 1 year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   27/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included published article).

  6. For how long will this data be available start date provided 02-01-2024 and end date provided 31-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   It is non randomized trial of family adoption program by medical undergraduate students. 50 intervention families are adopted where services are provided through interprofessional collaboration towards craeting awareness among families .50 control families will receive routine health services by the government.The patient empathy and communication skills are noted as baseline data and measured after 1 year.Family satisfaction level is recorded as baseline and measured after 1 year. 
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