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

NCT05353803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

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

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

Sponsors & Collaborators

  • Clinika de Kay SL

    lead INDUSTRY

Principal Investigators

  • Karina Anahi Ojanguren Carreira · Medical Director

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353803 on ClinicalTrials.gov