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CTRI Number  CTRI/2020/12/029474 [Registered on: 01/12/2020] Trial Registered Prospectively
Last Modified On: 20/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [General, Behavioural, Social, Cognitive strategies or support]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Family based Hypertension and diabetic management Intervention Package  
Scientific Title of Study   Effectiveness of an Integrated Chronic Condition Management Program in Indian Families of Patients with Hypertension and Diabetes Mellitus: a study Protocol for randomized control Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saju MD 
Designation  Assistant Professor, Vice Principal 
Affiliation  Department of Social Work, Rajagiri College of Social sciences (Autonomous) 
Address  Department of Social work, Rajagiri college of Social sciences, carmel block, 6th floor,room no:601, opposite to college main library Rajagiri P.O Kochi Kerala Pin:683104

Ernakulam
KERALA
683104
India 
Phone  9895346190  
Fax    
Email  saju@rajagiri.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saju MD 
Designation  Assistant Professor, Vice Principal 
Affiliation  Department of Social Work, Rajagiri College of Social Sciences (Autonomous) 
Address  Department of Social work, Rajagiri college of Social sciences, carmel block, 6th floor,room no:601, opposite to college main library Rajagiri P.O Kochi Kerala Pin:683104

Ernakulam
KERALA
683104
India 
Phone  9895346190  
Fax    
Email  saju@rajagiri.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Saju MD 
Designation  Assistant Professor, Vice Principal 
Affiliation  Department of Social Work, Rajagiri College of Social Sciences (Autonomous) 
Address  Department of Social work, Rajagiri college of Social sciences, carmel block, 6th floor,room no:601, opposite to college main library Rajagiri P.O Kochi Kerala Pin:683104

Ernakulam
KERALA
683104
India 
Phone  9895346190  
Fax    
Email  saju@rajagiri.edu  
 
Source of Monetary or Material Support  
Impactful policy Research in Social Care(IMPRESS),Indian Council of Social Science Research, Ministry of education, Aruna Asaf Ali Marg, New Delhi 110067 No-IMPRESS/P798/2045/2018-19/ICSSR  
 
Primary Sponsor  
Name  IMPRESS 
Address  IMPRESS, ICSSR,Aruna Asaf Ali Marg New Delhi IMPRESS/P798/2045/2018-19/ICSSR  
Type of Sponsor  Government funding agency 
 
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 
Dr Saju M D  Rajagiri College of Social Sciences(Autonomous)  Department of Social work, Rajagiri college of Social sciences, carmel block, 6th floor,room no:601, opposite to college main library Rajagiri P.O Kochi Kerala Pin:683104
Ernakulam
KERALA 
9895346190

saju@rajagiri.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajagiri Institutional Review Board(RIRB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention and Management 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioural Interventions to those participants who belong to the behavioural risk group  Behavioural interventions involve 1) giving out brochures for risk management on alcohol consumption, smoking, sedentary lifestyle, food intake; 2) linking to de-addiction centres if necessary; 3) video-based intervention that provides anatomical explanation about impact of unhealthy habits and sedentary lifestyle on chronic conditions; 4) obesity intervention by identifying potential patients using BMI and strict diet plan prescription. 
Intervention  Cognitive Interventions to those participants who belong to the psychological risk group  Cognitive interventions will involve 1) video interventions highlighting symptoms of anxiety and depression, cognitive and behavioural steps to manage anxiety and depression; 2) strategies to improve social cohesion and communication like encouraging common meals, family routines etc. Patients with severe cognitive dysfunctions will be referred to the nearest Family Counselling Centre (FCC). 
Intervention  General Interventions to all participants in the study  Information on the protective and motivating factors collected during the second level assessment will also be highlighted effectively for encouraging treatment adherence. Other major components involve: 1) brochure for health education with information on importance of medication adherence; 2) instructions to families to monitor treatment adherence and medication compliance and steps on how families can support (physically and emotionally) through reminders, positive encouragers etc; 3) common strategies for behavioural risk management such as diet chart, healthy recipe book and health calendar to be mounted on the kitchen wall; and pamphlets for simple and effective cognitive strategies like relaxation techniques, Personnel involved: Kudumbashree members and ASHA workers will be explaining in detail the above mentioned four strategies before handing out the brochures and pamphlets. Monitoring and coordination will be done by Research team and social worker. One-day training will also be given to all ASHA workers and Kudumbasree members prior to implementation of interventions. 
Intervention  Pick and choose of intervention to those participants who belong to more than one risk group  Behavioural, Social and Cognitive interventions will be customized based on their priorities. 
Intervention  Social Interventions to those participants in the social risk category  The intervention involves 1) formation of beneficiary groups of all participants in social risk group; 2) linking participants with voluntary clubs and NGOs for availing services like free medicines, micro-pharmacy, doctor emergencies, transport to hospital etc; 3) brochures on information of support services like information on government schemes, religious support groups, contact numbers and emergencies of support systems nearby etc. 
Comparator Agent  Usual care arm  Patients with hypertension and/or diabetes in the control arm will be also referred to PHCs or encouraged to access their preferred health care facility. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Eligible families will include those with at least one family member with
confirmed diagnosis of HTN and/or DM. The medical records of the patient will be used to
confirm the diagnosis. Informed consent will be obtained from all family members.
Additionally, family members must be either first degree blood relatives or spouses of the
patient. 
 
ExclusionCriteria 
Details  Bedridden and terminally ill patients will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
improving risk factor control status (BP 140/90 mmHg and fasting blood glucose (FPG) 110 mg/dl) and abstinence from smoking/ tobacco use.
 
Baseline and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
a) Increased compliance to medication b) reduction in quantity of salt, oil, sugar and meat intake c) sticking to diet chart and health calendar e) abstinence from alcohol consumption f) engagement in physical activity g) increased engagement with social system h) reduced depression and anxiety.   Baseline and 12 months 
 
Target Sample Size   Total Sample Size="740"
Sample Size from India="740" 
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)   06/01/2021 
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   This cluster randomized control study comprises of 740 participants and their families as the average number of HTN and/or DM cases in the community is 370 per 1000 population. Targeted chronic condition prevention and management can be an effective strategy to reduce the public health burden caused by NCDs in our country. Involving family members and engaging ASHA workers and other community members in health promotion will allow for sustainability of interventions by harnessing the potential of existing healthcare resources.  
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