CTRI Number	CTRI/2019/12/022435 [Registered on: 18/12/2019] Trial Registered Prospectively
Last Modified On:	13/12/2019
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Other (Specify) [DIGITAL HEALTH INTERVENTION]
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Development and impact of a healthcare decision support system on treatment outcomes of diabetes and hypertension
Scientific Title of Study	Development and impact of Healthcare decision support system on treatment outcomes of patients with diabetes and hypertension in a peri urban community
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  DR SARASWATHY M V  Address  DEPTT. OF COMMUNITY MEDICINE AND SCHOOL OF PUBLIC HEALTH PGIMER, CHANDIGARH Chandigarh CHANDIGARH 160012 India  Phone  9495161203   Fax     Email  drsmv.tmc@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  DR J S THAKUR  Address  DEPTT. OF COMMUNITY MEDICINE AND SCHOOL OF PUBLIC HEALTH PGIMER, CHANDIGARH Chandigarh CHANDIGARH 160012 India  Phone  9463602173   Fax     Email  jsthakur64@gmail.com
Details Contact Person Public Query	Name  DR SARASWATHY M V  Address  DEPTT. OF COMMUNITY MEDICINE AND SCHOOL OF PUBLIC HEALTH PGIMER, CHANDIGARH Chandigarh CHANDIGARH 160012 India  Phone  9495161203   Fax     Email  drsmv.tmc@gmail.com
Source of Monetary or Material Support	POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER) CHANDIGARH INDIA
Primary Sponsor Modification(s)	Name  DR SARASWATHY M V  Address  JUNIOR RESIDENT DEPARTMENT OF COMMUNITY MEDICINE AND SCHOOL OF PUBLIC HEALTH POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER) CHANDIGARH INDIA  Type of Sponsor  Other [INDIVIDUAL]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  DR SARASWATHY M V  URBAN HEALTH TRAINING CENTRE  ROOM NO.1 OUT-PATIENT DEPARTMENT URBAN HEALTH TRAINING CENTRE (UHTC) NEW INDIRA COLONY MANIMAJRA CHANDIGARH 160101 Chandigarh   9495161203 drsmv.tmc@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  INSTITUTE ETHICS COMMITTEE (INTRAMURAL) PGIMER  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Endocrine, nutritional and metabolic diseases
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  HEALTHCARE DECISION SUPPORT SYSTEM (HDSS)  THE INTERVENTION ARM WILL UNDERGO REGISTRATION IN HDSS A DIGITAL HEALTH INTERVENTION FOR TRACKING OF PATIENTS WITH DAIBETES OR HYPERTENSION WITH DECISION SUPPORT AND TARGETED CLIENT COMMUNICATION.IT IS A ONE TIME REGISTRATION FOLLOWED BY ADDITION OF CLINICAL DETAILS ON EVERY VISIT BY THE STUDY SUBJECT TP THE HEALTHCARE SETTING FOR THE WHOLE STUDY PERIOD OF 6 MONTHS.  Comparator Agent  NCD REGISTER  THE COMPARATOR ARM WILL BE PROVIDED WITH STANDARD OF CARE FOR REGISTRATION AND FOLLOW UP OF PATIENTS WITH DIABETES AND HYPERTENSION. THE SUBJECTS WILL BE ENTERED IN NCD REGISTER WHICH IS A PAPER BASED RECORD OF CLINICAL DETAILS AND MEDICATIONS, AND THE SAME UPDATED ON EVERY VISIT OF THE STUDY SUBJECT TO THE HEALTHCARE SETTING FOR THE STUDY PERIOD OF 6 MONTHS.
Inclusion Criteria	Age From  18.00 Year(s) Age To  99.00 Year(s) Gender  Both  Details  1. STUDY SUBJECT SHOULD BE IN THE CATCHMENT AREA OF UHTC INDIRA COLONY AND EXPECTED TO STAY FOR THE NEXT ONE YEAR PERIOD 2. ALL REPORTED CASES OF DIABETES AND HYPERTENSION (NEW AND OLD) AS OF JUNE 2019 AVAILING SERVICES FROM UHTC INDIRA COLONY AND CONSENTING FOR THE STUDY 3. THE SUBJECT SHOULD KNOW TO READ AND UNDERSTAND HINDI OR ENGLISH OR PUNJABI 4. THE SUBJECT POSSESSES MOBILE PHONE WITH OR WITHOUT INTERNET ACCESS 5. THE SUBJECT SCORES MINIMAL CUT OFF (MORE THAN 20) IN TECHNOLOGY FRIENDLINESS QUESTIONNAIRE
ExclusionCriteria	Details  1. ANY NEW CASE OF DIABETES OR HYPERTENSION DETECTED AFTER INITIATION OF INTERVENTION WILL NOT BE INCLUDED IN THE STUDY 2. SUBJECTS OUTSIDE THE CATCHMENT AREA OF UHTC INDIRA COLONY 3. SUBJECTS NOT CONSENTING FOR THE STUDY
Method of Generating Random Sequence	Stratified block randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  PATIENT TREATMENT OUTCOMES OF CONTROL OF DISEASE GLYCEMIC CONTROL IN DIABETES FBS LESS THAN 130MG/DL OR PPBS LESS THAN 180MG/DL OR HBA1C LESS THAN 7PERCENT BLOOD PRESSURE CONTROL IN HYPERTENSION LESS THAN 140/90MMHG FOR PATIENTS LESS THAN 60YRS AND LESS THAN 150/90MMHG FOR PATIENTS MORE THAN 60YRS   PATIENT TREATMENT OUTCOMES OF CONTROL OF DISEASE GLYCEMIC CONTROL IN DIABETES FBS LESS THAN 130MG/DL OR PPBS LESS THAN 180MG/DL OR HBA1C LESS THAN 7PERCENT BLOOD PRESSURE CONTROL IN HYPERTENSION LESS THAN 140/90MMHG FOR PATIENTS LESS THAN 60YRS AND LESS THAN 150/90MMHG FOR PATIENTS MORE THAN 60YRS
Secondary Outcome	Outcome  TimePoints  PATIENT HEALTH RELATED BEHAVIORS WITH STATUS OF BEHAVIOURAL RISK FACTORS (PHYSICAL ACTIVITY, HEALTHY DIET, TOBACCO USE, ALCOHOL USE) , MEDICATION ADHERENCE, FOLLOW UP ADEQUACY  BEFORE THE STUDY, EVERY 2MONTHS DURING INTERVENTION AND AFTER THE STUDY
Target Sample Size	Total Sample Size="210" Sample Size from India="210"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	20/12/2019
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	Nil
Brief Summary	The study aims to assess the impact of a digital health intervention ( Healthcare decision support system) in a clinic catering to diabetic and hypertensive patients in a peri urban community on treatment outcomes, health related behaviors and health systems and to evaluate its acceptibility among the clients and service providers. The study proposes a trial between the paper based services and digital services, and address acceptibility issues and thus aims to provide a base for provision of such interventions in similar populations. The hypothesis goes by an improvement in treatment outcomes in patients availing digital services owing to increase in medication adherence ( assumed to be 20percent in the study) and follow up adequacy.