Assessing the impact of mobile health technologies in resource limited areas
| ISRCTN | ISRCTN61479659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61479659 |
| Secondary identifying numbers | sssihms (wf)/HR/14 /) |
- Submission date
- 27/07/2016
- Registration date
- 29/08/2016
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
In recent years, heart disease has become more common in developing countries and less so in developed countries. This problem is made worse with resource-limited areas receiving a disproportionately low amount of global resources needed to look after patients including diagnostic tests and trained healthcare professionals. Coupled with the increase of rheumatic heart disease (a long-term heart condition which follows rheumatic fever, a sudden illness caused by a bacterial infection) and structural heart disease (an condition in which the heart does not function properly due to a problem with the valves or chambers), there is an urgent need to find a way to deliver cost-effective care. Smartphone-connected mobile health (mHeath) devices are providing new ways for patients to remotely monitor long-term conditions, and for providers to improve healthcare delivery at the point-of-care. Such mHealth devices include smartphone apps, wearable and wireless devices such as the smartphone-ECG (devices to monitor the electrical activity of the heart), sensor-based technologies, pocket-sized ultrasounds and miniaturized laboratory tests. The aim of this study is to investigate the effectiveness of these mHealth devices in the treatment of patients with rheumatic and structural heart disease in resource-limited areas.
Who can participate?
Patients with rheumatic or structural heart disease.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard health care. Those in the second group receive mHealth care at a mHealth clinic. This involves having their vital signs and health heart monitored using a range of mobile devices. Participants in both groups receive a complete transthoracic echocardiogram (ultrasound of the chest to view the heart) to establish the severity of their rheumatic or structural heart disease. Participants are followed up over 12 months to find out how quickly participants are able to receive surgery to correct their heart defect.
What are the possible benefits and risks of participating?
Participants benefit from receiving a more timely decision about treatment and a more comprehensive assessment of the severity of disease at the time they see a doctor. In addition, participants in this study benefit from being closely monitored through follow up. There are no notable risks involved with participating.
Where is the study run from?
Sri Sathya Sai Institute of Higher Medical Sciences (India)
When is the study starting and how long is it expected to run for?
August 2014 to October 2015
Who is funding the study?
Academic Medical Center (Netherlands)
Who is the main contact?
Dr Partho Sengupta
partho.sengupta@mountsinai.org
Contact information
Scientific
Icahn School of Medicine at Mount Sinai
1 Gustave L. Levy Place
New York
10029
United States of America
| Phone | +! 212 659 9121 |
|---|---|
| partho.sengupta@mountsinai.org |
Study information
| Study design | Nested multi-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A Randomized Trial of Mobile Health Device Assessments in Structural Heart Disease Clinics |
| Study acronym | mHealth in Structural Heart Disease |
| Study objectives | A mHealth assessment with smartphone-based diagnostic devices such as the smartphone-ECG, handheld ultrasound, activity monitoring, and point-of-care laboratory tests accelerates medical-decision-making and shortens the time to definitive therapy among patients with structural heart disease in a resource limited area. |
| Ethics approval(s) | Sri Sathya Sai Institute of Higher Medical Sciences - Institutional Review Board, 05/01/2014 |
| Health condition(s) or problem(s) studied | 1. Rheumatic Heart Disease 2. Structural Heart Disease |
| Intervention | Consecutive subjects are randomly assigned to an initial evaluation with mHealth or to standard-care. Study subjects are evaluated in either one of 5-mHealth or 5-standard-care sites. Intervention group: Participants undergo an initial assessment of heart disease with mHealth devices including: 1. Structural abnormalities with handheld-echocardiography (Vscan®, GE Healthcare) 2. Vital signs with smartphone-connected oxymetry and blood pressure monitors (iHealthLabs®) 3. Functional assessments on a 6-minute walk test with a trial-axial activity monitor (Ozeri®) 4. Cardiac rhythm abnormalities with smartphone-connected-iECG (AliveCor®) 5. Point-of-care testing with fingerstick B-type natriuretic peptide (Alere) Control group: Participants undergo a usual assessment with diagnostic tests that are available at the institution. This includes a physical examination, electrocardiography and radiographic and laboratory tests where necessary. All study participants undergo a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease and underwent a consultation by expert cardiologists prior to percutaneous valvuloplasty or a surgical valve replacement. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Time to definitive treatment with valvuloplasty or valve replacement over 12-months is determined at the time of a healthcare encounter for valvuloplasty or valve replacement through monthly medical record review. |
| Secondary outcome measures | Occurrence of a cardiovascular hospitalization and/or death over 12-months is determined via monthly medical record review, community health worker visitation to the home, and text message follow up with the patient and care giver inquiring about a hospitalization and/or death. |
| Overall study start date | 15/07/2013 |
| Completion date | 01/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 286 |
| Key inclusion criteria | 1. Symptomatic outpatients with a new or an established diagnosis of rheumatic and structural heart disease, including valvular disease, left/right ventricular failure, rheumatic valvular disease, congenital heart defects 2. Adult, pediatric, and pregnant patients 3. Patients with a prior valvuloplasty or valve replacement for structural heart disease can also be included |
| Key exclusion criteria | 1. Neonatal patients 2. Those with an unstable hemodynamic status |
| Date of first enrolment | 10/08/2014 |
| Date of final enrolment | 01/10/2015 |
Locations
Countries of recruitment
- India
Study participating centre
Karnataka
Bangalore
560 066
India
Sponsor information
Research organisation
2100 Gateway Centre Boulevard, Ste. 310
Morrisville
27560
United States of America
| Phone | +1 919 861 5574 |
|---|---|
| ase@asecho.org | |
| Website | http://asecho.org/ |
"ROR" |
https://ror.org/059gy7s73 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Peer review medical journal with submission planned for 2016 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | 29/01/2019 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added
