FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/01/011111 [Registered on: 02/01/2018] Trial Registered Prospectively
Last Modified On: 02/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of education and mobile SMS reminder to increase drug intake in chronic kidney patients with cardiovascular disease 
Scientific Title of Study   Effect of behavioural intervention using education and SMS reminders on medication adherence in chronic kidney disease patients with co-existing cardiovascular disease-A randomised controlled 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 Pradeep T 
Designation  Pharmacology post graduate 
Affiliation  St Johns medical college 
Address  Room no :103 Nirmala block St Johns medical college Department of Pharmacology Bangalore Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  8220586899  
Fax    
Email  pradeep91t@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Denis Xavier 
Designation  MD Pharmacology 
Affiliation  St Johns medical college 
Address  Professor, Department of Pharmacology, St Johns medical college, Koramangala, Bangalore, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  9886126801  
Fax    
Email  denis.xavier@stjohns.in  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep T 
Designation  Pharmacology post graduate 
Affiliation  St Johns medical college 
Address  Room no :103, Nirmala block, St Johns medical college, Department of Pharmacology, Bangalore, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  8220586899  
Fax    
Email  pradeep91t@gmail.com  
 
Source of Monetary or Material Support  
Dr.Pradeep T Pharmacology Post graduate St Johns medical college Bangalore Karnataka-560034 
 
Primary Sponsor  
Name  Dr Pradeep T 
Address  room no:103 nirmala block st Johns medical college bangalore karnataka 
Type of Sponsor  Other [self funding] 
 
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 Pradeep T  St Johns medical college hospital  Department of Nephrology Koramangala Bangalore Karnataka
Bangalore
KARNATAKA 		 8220586899

pradeep91t@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, St. John’s National Academy of Heath Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic kidney disease patients with coexisting cardiovascular disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group  - The participants in these group received usual standard care with regular follow-up with the Nephrologist with regular advice about diet and medication from them. 
Intervention  Intervention group  -we provide systemic education using a diary which also has pill intake records at end and also provide motivational discussion based on barriers identified for medication adherence - we also sent one SMS reminder per week based on adherence,disease and diet 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed chronic kidney disease stage 1 to 4 with atleast one cardiovascular disease risk factor such as diabetes mellitus, hypertenion, dyslipidaemia or etablished cardiovascular disease 
 
ExclusionCriteria 
Details  1.psychiatric disorder or visual disturbance without a care taker
2.patients who are unlikely to follow up for 3 months
3.patient or care giver without mobile phones or unable to read english messages
4.critically ill patients or on dialysis
5.patients who dont know languages such as tamil, english, kannada and malayalam 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure adherence at the end of 3 month in both groups  To measure adherence at the end of 3 month in both groups 
 
Secondary Outcome  
Outcome  TimePoints 
To measure clinical outcome and knowledge at the end of 1 and 3 months  To measure clinical outcome and knowledge at the end of 1 and 3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/02/2018 
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="6"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Background:
The burden of chronic kidney disease is exponentially increasing. The complexity of treatment, lack of knowledge and increasing number of associated comorbidities lead on to non-adherence to treatment. Poor adherence to the treatment is a key factor that leads to progression of disease and mortality especially the cardiovascular mortality. The SMS  and education based intervention is found to improve medication adherence in many diseases.There are no SMS based behavioral intervention studies to improve adherence in Chronic kidney disease with coexisting cardiovascular disease in India. we confirmed this by searching PUBMED using the following MeSH terms from years 2007 to June 2017: behavioral intervention, SMS, chronic kidney disease, chronic kidney disease and cardiovascular disease and adherence.We are therefore proposing a behavioral interventional study using education and SMS reminders to assess its effect on medication adherence among patients with co-existing CKD and CVD
Objective:
Among Chronic kidney disease patients with established cardiovascular disease or its risk factors visiting a tertiary care teaching hospital:
Primary objective:

-       To assess the effect of education and SMS reminders on medication adherence at 3 months

     Secondary objectives:

-       To assess the clinical outcomes at the end of 3 months

-       To assess the Knowledge, Attitude and Practices (KAP) about disease at the end of 3 months in both groups

      Methodology:

 - In-patients will be identified as per selection criteria mentioned above from the relevant departments of St. Johns medical college hospital. The consultants from the respective deparments will help in indentification of cases. A written informed consent from the patient and his/her first degree relative will be taken. We random list the days of recruitment from the in-patient wards of relevant departments based on computer generated random list.Then we will note down the baseline demographic data, KAP, lab parameters and medication adherence using morisky adherence measuring scale and pill count method.
  - Then we randomize the patient using a variable block randomization in a 1:1 allocation ratio to either intervention or control group
  - Intervention group received education using a booklet at the time of discharge which has pill intake records at the end. They will also been given motivational discussion based on barriers identified at baseline and at every follow-up. The patients in intervention will also been sent one SMS in week based on 4 domains. During the 1st month follow-up either personal or through mobile, we ask about message delivery, give motivational discussion and also we measure adherence. During the final follow-up at 3rd month we measure KAP, clinical status and medication adherence
  - Control group received usual standard care with routine follow-up with the physician and regular advice about the diet and medication by the physician. During the 1st month follow-up either personal or through mobile, we ask about message delivery and also we measure adherence. During the final follow-up at 3rd month we measure KAP, clinical status and medication adherence.
      Statistical methods:
         -Data entry will be done using Epi Info version 7.2. All statistical analyses will be performed using Statistics Package for the Social Sciences (SPSS) version 21.
         -Demographic and base line variables such as age, gender, socio-economic status will be analysed using descriptive statistics.
         -Continuous variables such as glucose levels, HbA1C, BP, lipid profile and serum creatinine levels will be summarized using mean (± SD) and analysed using t-test/ANOVA.
         -Clinical / lab parameters between 2 groups will be analysed using Chi-square or student t-test.
         -Difference of change in adherence between the two groups from baseline will be analysed using chi squared tests and determinants of adherence explored using multivariate analysis.
         A p value <0.05 will be considered significant for all tests.
 
Close