| CTRI Number |
CTRI/2021/12/038617 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
10/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Smartphone app for heart attack patients- A Clinical Trial |
|
Scientific Title of Study
|
Smartphone based application for drug adherence and risk factor modification in outpatients with coronary artery disease – an open label randomized 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 Santhosh Satheesh |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Cardiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443426244 |
| Fax |
|
| Email |
drsanthoshsatheesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh Satheesh |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Cardiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443426244 |
| Fax |
|
| Email |
drsanthoshsatheesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurav Banerjee |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Cardiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9874657534 |
| Fax |
|
| Email |
bsaurav0206@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Alumni Association of North America |
|
|
Primary Sponsor
|
| Name |
JIPMER Alumni Association of North America |
| Address |
28072 Clima, Mission Viejo, CA 92692, USA |
| Type of Sponsor |
Other [Alumni Association of JIPMER] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jawaharlal Institute of Postgraduate Medical Education and Research |
Dhanvantari Nagar, Pondicherry 605006 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santhosh Satheesh |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
Room Number: 5027,
Cardiology OPD, Ground Floor, Super Specialty Block, JIPMER, Dhanvantari Nagar, Pondicherry- 605006.
Pondicherry
PONDICHERRY |
9443426244
drsanthoshsatheesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active App |
Active App will be customised based on patient profile and risk factors; will actively interact with the patient through alerts, reminders and warnings, based on automatically captured data (steps per day, inactivity, sleep per day, clicks on stress and medication screens) and actively entered patient data weekly (Every Sunday- BP, HR, Blood sugars (for diabetics only), Diet Scoring, Smoking Scoring, Alcohol Scoring, Stress Scoring) |
| Comparator Agent |
Control App |
Control App will only monitor and display steps walked and sleep data to the patient. Control patients will be given a diary to record their weekly BP HR and blood sugars (for diabetics). Both groups will receive guideline directed standard cardiac care. Follow up visits will be scheduled at 30 days interval till 180 days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinically documented stable CAD attending cardiology OPD of JIPMER hospital.
2. 18 years to 64 years
3. Able to use a smart phone with android function
4. Able to read English or Tamil
|
|
| ExclusionCriteria |
| Details |
1. Recent ACS or PCI within 1 month
2. Patients awaiting revascularization
3. Has visual, auditory, cognitive or motor impairment
4. LVEF<35%
5. COPD, Peripheral Vascular Disease, Post Pacemaker
6. Recent CABG within 6 months.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Medication adherence will be measured by assessing the number of adherence failure events (defined as 1 missed dose during a observation cycle of 30 days) using pill counting method and Medication adherence score.
Improvement of CV risk factor targets (defined before).
|
Medication adherence will be measured by assessing the number of adherence failure events (defined as 1 missed dose during a observation cycle of 30 days) using pill counting method.
Improvement of CV risk factor targets (defined before).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Quality of Life, Stress level and Quality of sleep are the secondary outcomes measured at baseline, 12 weeks and 24 weeks |
3 |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
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)
|
15/12/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Digital health intervention randomized controlled trial analyzing an Android smartphone application for achieving risk factor modification and medication adherence in stable coronary artery disease patients for six months. |