| CTRI Number |
CTRI/2018/10/015956 [Registered on: 09/10/2018] Trial Registered Prospectively |
| Last Modified On: |
08/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effect of tools on medication adherence in heart failure patients |
|
Scientific Title of Study
|
A randomized controlled trial to study the effect of medication adherence tools in heart failure patients (MAT-HF) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhupendra Pawar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Room no. 4046-D, Department of Pharmacology, fourth floor, teaching block, AIIMS , New Delhi
Ansari Nagar, New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
7000205120 |
| Fax |
|
| Email |
bhupendrapawar20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Maulik |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room no. 4017, Department of Pharmacology, fourth floor, teaching block, AIIMS , New Delhi
Ansari Nagar, New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
01126593540 |
| Fax |
|
| Email |
skmaulik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhupendra Pawar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Room no. 4046-D, Department of Pharmacology, fourth floor, teaching block, AIIMS , New Delhi
Ansari Nagar, New Delhi - 110029
DELHI
110029
India |
| Phone |
7000205120 |
| Fax |
|
| Email |
bhupendrapawar20@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SANDEEP SETH |
AIIMS |
Room no. 1, cardiology OPD, CN toer, AIIMS, Ansari Nagar, New Delhi - 110029
New Delhi
DELHI |
01126594970
drsandeepseth@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEDICATION ADHERENCE TOOLS |
Components of medication adherence tools :
1) HRIDAY card-: Hriday Card is a simple 4 page card which consists of following elements:
Page 1- The basic information about the patient and the primary care provider
Page 2- Diagnosis of the patient , drugs being prescribed and vaccinations.
Page 3- Daily symptoms monitoring and accordingly when to seek for medical help.
(Divided in three zones – red, yellow and green)
Page 4- Lifestyle Modification measures to control heart failure.
It also has an extra sheet containing daily weight monitoring log and medicine chart (all medicines prescribed with their dosage and frequency)
Hriday Card is a very simple MAT to improve Medication Adherence and facilitate patient care in heart failure.
2) DHADKAN 2 app-: It is a mobile app where the patient needs to send his blood pressure, heart rate and weight to the registered medical personnel (doctor/nurse/paramedic) once a week. It also has facility to send photographs (ECG & Medicines). It also serve as a medium for communication between the healthcare provider and the patient.
In condition when there are serious changes (possibility of imminent heart failure) in the data send by patient it automatically alerts the healthcare provider and patient.
3) ABCD regime prescription with separate ZIP LOCKS for each class-: Prescription form are given in the ABCD format and the patients are also directed to put there medicines in separate labelled zip locks for all the four classes of drugs.
To facilitate better understanding of drugs being prescribed to the patient, and improve medication adherence. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18 to 60 years.
2) NYHA class 2 or 3 heart failure patients of either gender visiting the Cardiology OPD .
3) Referred patients from other clinics having previous prescription.
4) Participant willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1) Patient already recruited for other trial.
2) Patients with major organ dysfunction like renal dysfunction (Blood Urea > 50mg%,
S.Creatinine > 1.8mg%) hepatic dysfunction (AST/ ALT/ ALP/ Total S. Bilirubin > 3 times the
upper normal limit).
3) Pregnancy and lactation.
4) With other co-morbid conditions like uncontrolled diabetes mellitus, uncontrolled
hypertension and malignancy.
5) Patients with rapidly progressing disease |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in medication adherence by measuring change in Morisky, Green, and Levine (MGL) Adherence Scale score. |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in patient functional capacity by measuring change in Likert score. |
At baseline and follow up after 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/10/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TITLE : A randomized
controlled trial to study the effect of medication adherence tools in heart
failure patients (MAT-HF)
Heart failure is one of the commonest health
problems among cardiovascular diseases in India and all over the world which
constitutes a major burden over the healthcare system of a country.
It is a chronic disease where long
term medications are needed therefore medication adherence plays an important
role in the disease progress and outcome. Interventions are necessary to
improve medication adherence. This is a randomised control study to see the
effect of MAT (medication adherence tools) in heart failure patients.
Primary objective:
To determine the efficacy of
medication adherence tools in heart failure patients as an adjunct to improve
drug adherence as compared to patients on standard prescription.
Secondary objectives:
To study
improvement in patient functional capacity to medication adherence by Likert
scale and to describe the prescription pattern prescribed by general physicians
before referring to AIIMS.
MATERIALS AND
METHODS
Study design: A open
label , parallel group , randomized controlled study.
Study site: Cardiology
outpatient department (OPD), All India Institute of Medical Sciences (AIIMS),
New Delhi.
Study duration: 2 years.
Study population: Heart
failure patients (NYHA class 2 or 3) from cardiology OPD, AIIMS , New Delhi.
Sample
size: To the best of our knowledge no prior work like this is available so
200 patients (100 in each group) will be recruited.
STUDY
WORKFLOW
Patients satisfying the inclusion criteria will be
recruited after receiving Informed Consent from them.
Block randomisation will be done and patients will be
divided into two groups-the control group and the intervention group.
The control group patient will receive the standard
prescription and the intervention group will receive medication adherence tools
in addition to standard prescription.
The enrolled patients will be assessed for their
medication adherence through Morisky, Green, and Levine (MGL) Adherence Scale
and their functional capacity will be assessed through Likert scale at baseline
and after12
± 2 weeks.
|