mHealth ALIBIRD: A Digital Health Care Model

NCT ID: NCT05770869

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2022-10-28

Brief Summary

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The aim of this pilot study was to evaluate the feasibility and acceptability of the ALIBIRD platform, a new mobile health (mHealth) application prototype design for personalized and remote support on the follow-up of cancer patients. The ALIBIRD platform is a mHealth intervention that tracks PROs, improving symptom control and allowing real-time feedback, and provides personalized recommendations and educational content, promoting empowerment and encourage healthy lifestyle behaviors in patients with thoracic neoplasms in active treatment.

Detailed Description

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The investigators have developed an innovative mHealth platform that provides personalized recommendations based on Patient Reported Outcomes (PROs) records and the study of patient´s nutrigenomics and gut microbiome. The usability of the ALIBIRD mHealth platform prototype is being tested in a 28-week pilot study carried out at Infanta Sofía Hospital. A small group of stage IV thoracic neoplasms patients (n=20) were asked to participate. All the participants gave informed consent.

Conditions

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Thoracic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ALIBIRD mHealth platform

Participants are followed-up using the ALIBIRD mHealth platform. The ALIBIRD platform is made up of a mobile application for patients and a web application for the healthcare team. Through the ALIBIRD mobile application, patients regularly register Patients Reported Outcomes (PROs) and Patients Reported Outcome Measures (PROMs) regarding lifestyle (diet, physical activity, sleep, mood), and get access to individualized recommendations in order to assume more responsibility for achieving the best outcomes from their care. Moreover, the patient application includes features for tracking the appearance of symptoms, with alerts sent to the healthcare team in response to these parameters. In addition, the application contains articles and educational information.

Group Type EXPERIMENTAL

ALIBIRD mHealth platform

Intervention Type DEVICE

Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.

Interventions

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ALIBIRD mHealth platform

Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with thoracic neoplasms, histologically or cytologically confirmed.
* \< 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patients receiving cancer treatment: chemotherapy, chemotherapy-immunotherapy, immunotherapy or biological therapy.
* Patients with internet access and intermediate level in the use of technology (Smartphone, mobile applications, wearable)
* Signed informed consent.

Exclusion Criteria

* Patients with symptomatic brain metastases.
* Patients with neurological impairment, dementia or psychiatric disorders.
* Patients unable to follow the protocol due to psychological, social or geographic reasons.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Infanta Sofia

OTHER

Sponsor Role collaborator

Universidad Politecnica de Madrid

OTHER

Sponsor Role collaborator

IMDEA Food

OTHER

Sponsor Role collaborator

Instituto de Investigación en Ciencias de la Alimentación (CIAL)

UNKNOWN

Sponsor Role collaborator

Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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María Sereno Moyano, Medicine

Role: PRINCIPAL_INVESTIGATOR

Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

Locations

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Servicio de Oncología. Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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mHA

Identifier Type: -

Identifier Source: org_study_id

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