NCT05353803

Digital App and Platform for Supporting Medicines Control and Optimization in Older Individuals With Heart Failure

Completed NA Last updated 8 February 2024

What this trial tests

NA trial testing Digital App and Platform for Supporting Medicines Control and Optimizationin Older Individuals With Heart Failure in Heart Failure in 9 participants. Completed in 31 January 2023.

Timeline

1 July 2022

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Clinika de Kay SL
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	9
Start date	1 July 2022
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across Spain

Drugs / interventions tested

• Digital App and Platform for Supporting Medicines Control and Optimizationin Older Individuals With Heart Failure

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Clinika de Kay SL

Who can join

60 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The intervention being piloted in this study is a novel system of supporting older individuals (\>60 years old) with heart failure to self-manage their chronic condition through the use at home of a digital health tool that facilitates the collection and visualisation of their health data and also enables remote visualisation by health professionals. This pilot is a feasibility study in order to have a first evaluation of the engagement and user-perceived usefulness of the novel system in a real-world environment. An equivalent study will be carried out in Germany (GEWI institute). In addition, collected data will serve to validate retrospectively a heart failure decompensation prediction model (VICOMTECH, Spain) and do research into correlations with disease control (TREE TECHNOLOGY, Spain). Finally, this project is undertaken within the European project SHAPES (www.shapes2020.eu).

Older person participants (users of HUMANA GROUP services) will be asked to download the SHAPES app to their own smartphone. Medical devices - specifically, a body composition scale, a blood pressure monitor, a pulse oximeter - and a non-medical, CE-marked activity wristband, will also be provided to participants for use at home. Participants will be encouraged to take daily readings with medical devices and wear the wristband at all times. Participants can view their data via the app, which collects the readings either via Bluetooth or manually inserted by the participant. Participants will also be encouraged to complete surveys via a chatbot in the app, with questions about health status (daily), the use of medicines (weekly) and whether there are updates in medication, use of health care resources or lab test results (as required).

Health professional participants (medical doctors at HUMANA GROUP) will be able to visualise some of the collected data via: 1) eCare dashboard (data from medical devices; it is worth highlighting that they will only visualise the data coming from medical, that is not from the wristband, in order to avoid interference of non-medical information); and 2) ROSA dashboard (data from surveys and other medical data collected at baseline and during the intervention, i.e. medication, use of health care resources and lab test results). Health professional participants will use the dashboards on a daily basis and may decide to contact the older person participants for further medical evaluation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.